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IEPM'S NEW PRESCRIPTION
’m so excited to introduce myself as the new editor of European Pharmaceutical Manufacturer! After spending almost three years in the medical industry, I’ve had the privilege of seeing how interconnected and impactful our work can be. Now, I’m thrilled to shift my focus to the pharmaceutical sector.
Before stepping into this role, I was the editor of Medical Plastics News. There, I covered everything from high-performance polymers to regulatory updates. That experience gave me a front-row seat to the incredible collaboration and innovation that define this amazing industry. I’m looking forward to building on that foundation here at EPM.
challenges, or setting new sustainability standards. It’s inspiring to see how much this sector achieves, and I’m honoured to have the chance to share your stories.
The past few years have been a powerful reminder of what this industry can do. During the pandemic, the pharmaceutical sector came together to deliver vaccines, ramp up manufacturing, and find creative ways to get treatments to those who needed them most. It showed just how vital this work is—and how much of an impact it has on the world.
advances in areas like digital transformation and AI, there’s so much to explore—and I can’t wait to dive in.
One thing I’ve learned during my time in this industry is the power of sharing knowledge. The pharmaceutical sector thrives on collaboration, and that’s exactly what EPM is all about: being a platform for ideas, insights, and meaningful discussions. Whether it’s through case studies, expert interviews, or guest articles, I’m eager to highlight the incredible work being done and amplify your voices.
Address changes should be emailed to subscriptions@rapidnews.com
European Pharmaceutical Manufacturer is published by Rapid Life Sciences Ltd. European Pharmaceutical Manufacturer is distributed in electronic and print formats to a combined readership of 14,000 pharmaceutical manufacturing professionals.
Volume 24 Issue 5 Nov/Dec 2024
While every attempt has been made to ensure that the information contained within European Pharmaceutical Manufacturer is accurate, the publisher accepts no liability for information published in error, or for views expressed. All rights for European Pharmaceutical Manufacturer are reserved and reproduction in part or whole without written permission is strictly prohibited.
My goal for EPM is simple: to keep it as a trusted resource for you while adding my own perspective. From exploring manufacturing techniques to navigating complex regulations, I want the content to reflect the topics that matter most to you. With exciting
EDITOR’S DESK
For me, this isn’t just a job—it’s an opportunity to connect with the people shaping the future of healthcare. I’d love to hear from you, whether it’s feedback, story ideas, or just a quick chat about what’s happening in your world. Your input will be invaluable in helping make EPM even better.
OLIVIA FRIETT
I’m really looking forward to this journey and getting to know you all. Thank you for welcoming me into the EPM community and trusting me to guide this publication. Together, I know we can continue to inform, inspire, and innovate.
"The pharmaceutical sector thrives on collaboration, and that’s exactly what EPM is all about."
The role of alarm annunciators in PRESERVING LIFE-SAVING MEDICATION
The use of IoT Technology in the era of Industry 4.0 is widespread, so the benefits of remote monitoring key assets are more compelling than ever. It provides laboratory managers, pharmaceutical manufacturers and distributors with a convenient and costeffective way of managing system performance.
In hospitals and clinical environments globally, cryopreservation units are used to store everything from human tissue samples to blood and bone marrow. In these applications, managing the temperature of storage facilities is paramount, and continuous monitoring is essential to managing sample and medication storage.
Therefore, it is an increasingly important requirement for lab managers to validate the cold chain of all materials with specific temperature storing requirements. Famously, the Pfizer coronavirus vaccine had very strict temperature requirements for long-term storage and transportation.
Temperature monitoring is a critical requirement in various industrial settings, this is especially important in the pharmaceutical sector when various medicines require storage at set temperatures for preservation. Here Ian Loudon, international sales and marketing manager at alarm annunciator specialist Omniflex, explores the importance of alarm annunciators in monitoring the temperature in pharmaceutical and laboratory environments.
Ensuring that medications are stored at the right temperature means that they can preserve chemical integrity – meaning that active ingredients won’t degrade or decay. This helps protect the patient from any unintended side effects and preserves any medication’s effectiveness.
Good monitoring systems allow any potential problems to be quickly identified, allowing them to be rectified and ultimately preserving the medication, helping save money from any waste that may otherwise be incurred.
Alarm annunciators with built-in
Built-in remote monitoring technology also enables text and email alerts to be sent to relevant personnel, such as lab managers and maintenance technicians, so they can act quickly to protect research samples. This prevents the previously common occurrence of systems failing overnight only to be discovered the following working day when the damage is already done.
Alarms are sent to key personnel via text message, email and even pop-up alarm messaging on a computer. Alarms are managed using duty schedules preprogrammed into the system to ensure off duty personnel are not bothered. Alarm recipients must acknowledge the alarm within reasonable time periods otherwise the alarm is escalated to another group of recipients for action.
remote monitoring provide lab managers with the most costeffective means of validating freezer system performance. They do this by being hardwired directly into the monitored processes, in this case the cryofreezers in labs, so there is no risk of network failures that impede the alarm’s performance.
In the event of the temperature deviating outside of normal limits, the relevant panel on the annunciator lights up and an alarm sounds, sending a clear signal to all nearby personnel that the freezer is in an abnormal state.
There are three escalation groups. Often the facility will have 24/7 security who can also be mobilised to action in the event of alarms. These techniques help mitigate the risk of alarms being overlooked or missed.
Omniflex has worked with research labs, such as at Oxford University and South Africa’s Medical Research Council, to install this technology and help lab managers overcome challenges with cryopreservation and have long-term confidence in the cold chain for their stored materials.
LogiPharma marks 25 years in 2025 with return to Lyon A small dose
LogiPharma, a life sciences supply chain event, is returning to Lyon in 2025 where it will celebrate its 25th anniversary. Hosted at the Palais des Congrès on 8 – 10 April, the milestone event is expected to attract 2,500 attendees from across the global life sciences industry. Leaders and companies from the pharmaceutical, logistics, and biotech sectors will once again have the opportunity to share insights, gain valuable knowledge and build essential industry connections.
First held in Geneva, LogiPharma has grown
from a 120-attendee, European-focused logistics event to one of the world’s leading platforms for advancing the life sciences supply chain. Industry representatives from the U.S, Europe, Asia, the Middle East and Africa will attend the 2025 edition, reflecting the event’s expansion to a truly global event.
“From our early days as a logistics-focused gathering in Switzerland, LogiPharma has evolved to
become the essential meeting point for supply chain professionals,” said Jake Brown, commercial lead at LogiPharma. “We’re delighted to see the extensive range of representation at LogiPharma today, with attendees from around the world spanning the breadth of the life sciences sector.”
The 2025 conference promises an updated and tailored agenda focused on the key topics that are essential for the industry’s future. Visitors can expect panel discussions, conference tracks and masterclasses addressing critical areas such as Artificial Intelligence, Sustainability, Strategy & Planning, Digital Transformation, TemperatureControlled Operations, Logistics, and Distribution, among others.
“LogiPharma continues to play a crucial role in enabling professionals to stay informed about trends and drive improvements to patient care throughout the entire end-to-end supply chain,” concluded Will Robinson, LogiPharma’s conference director.
“As we prepare to celebrate our 25th anniversary, we look forward to welcoming attendees back to Lyon for engaging discussions that will help shape the future of the industry.”
STARGET PHARMA SECURES $5.1 MILLION FOR TARGETED
ARC Innovation, the innovation branch of Sheba Medical CenterIsrael’s largest hospital and a global leader in clinical trials and medical advancements - announced the successful $5.1 million funding round of Starget Pharma, a startup specialising in precise cancer diagnosis and targeted radiotherapy. The investment was secured from Cancer Focus, a fund established in collaboration with the MD Anderson Cancer Center at the University of Texas, one of the world’s leading cancer centres.
Founded in 2019 via ARC, Starget Pharma is at the forefront of developing innovative radioligand-based therapies that precisely target tumour cells with focused radiation, minimising damage to surrounding healthy tissue. The funds will support an upcoming clinical trial aimed at treating cancers such as sarcomas,
neuroendocrine tumours, melanoma, and liver cancer. The trial will be conducted at the University of Texas and other leading institutions, with patient recruitment
expected to begin in early 2025.
Before this investment, Starget Pharma has raised a total of $10 million to date. The company, cofounded by CEO Sigal Clemenson-Kushnir and chairman Ronen Clemenson, leverages AI technology to accelerate the development of personalised cancer therapies.
Starget Pharma’s innovative platform combines diagnostic imaging with targeted radiotherapy to create a personalised treatment approach for advanced metastatic cancers. The platform’s AI-driven technology enables
CANCER THERAPY
highly accurate radiation delivery to tumour cells, offering greater precision and a broader therapeutic range than traditional radiotherapy. This approach could advance cancer treatment by providing safer and more effective alternatives, particularly for patients with advanced cancers and limited treatment options.
CEO Sigal Clemenson-Kushnir said: “This investment highlights the potential of our radioligand-based technology to deliver safer and more effective treatments for complex cancers. We look forward to collaborating with MD Anderson in our upcoming clinical trial, where early studies have already demonstrated safety and strong tumour cell uptake. We believe our technology offers a significant alternative to existing therapies, particularly for patients facing advanced cancer with limited treatment options.”
Prof. Yitshak Kreiss, director general of Sheba Medical Center, commented: “The decision of a leading institution like MD Anderson to invest in Israeli medical innovation is yet another vote of confidence in our high-tech nation. It underscores the growing recognition that healthcare is a powerful engine of growth.”
ACG Inspection debuts Life Sciences Cloud for improved data insights
At Pack Expo US 2024, ACG Inspection will be debuting its Life Sciences Cloud - a complete end-to-end analytical and traceability solution which aims to deliver production quality, manufacturing effi ciency and transformational supply chain traceability - empowering customers to create a healthier world.
As the pre-eminent integrated service provider of oral dosage, producing capsules, encapsulation, tabletting, barrier packaging materials, process manufacturing/ packaging machinery, quality inspection systems and traceability solutions to the pharmacies of the world, ACG is launching its Life Sciences Cloud. The solution provides a complete and holistic approach to manufacturing, packaging and traceability at the click of a button.
The Life Sciences Cloud gives pharmaceutical companies the ability to visualise the entire manufacturing process on a very simplistic dashboard providing powerful insights enabling maximum operating effi ciencies. It aims to deliver end-toend supply chain traceability from raw material to end consumer, keeping the sanity of the integration and data exchange. This encompasses supporting global regulatory compliances, including the impending Drug Supply Chain Security Act
(DSCSA) regulation.
The Life Sciences Cloud platform is designed to be user-friendly and effi cient, enabling companies to obtain the information they need quickly and easily. It is also highly scalable and, therefore can grow alongside a business. The customer engagement layout within the platform allows pharmaceutical companies to add engagement tools along with the mandatory fi elds for regulation guidelines. This not only builds trust by verifying product authenticity but also helps to foster strong customer relations.
Udit Singh, CEO at ACG Inspection, said: “At ACG, our mission is to tailor technological innovations specifi cally designed to enhance the pharmaceutical industry. Whether it’s effi cient manufacturing, higher OEE, harnessing the power of supply chain intelligence, demand forecasting, sustainable production methods, diversion control or implementing cutting-edge anticounterfeit technologies, we have been at the forefront of innovations utilising machine learning, AI and advanced analytics to elevate the quality of various critical processes and applications. ALSC is one such product that gives us confi dence to go a step closer to our mission of Make it Better.”
PLANOVA FG1 BRINGS A STEP FORWARD IN BIOPHARMA MANUFACTURING
In the rapidly evolving landscape of biopharmaceuticals, innovation is paramount. The introduction of Planova FG1 as a new product showcases significant advancements in the field, particularly in enhancing the safety and efficiency of biopharmaceutical manufacturing.
UNDERSTANDING THE CURRENT ENVIRONMENT
Trends in biopharmaceutical development have been marked by a shift towards targeting more complex diseases. This shift is driven by the need to offer innovative solutions for diseases that have historically had limited treatment options. For example, though cancer remains a primary focus, there is increasing interest in addressing formidable illnesses such as Alzheimer’s disease and autoimmune diseases.
In addition, the acceleration of biosimilar development has introduced a new dimension to the market. Biosimilars are emerging as cost-effective alternatives to existing biopharmaceuticals, driving down prices and expanding access. This price reduction is instrumental in the democratisation of biopharmaceuticals, making these advanced treatments more accessible to wider populations than ever before.
To continue growing/expanding this widespread access, biopharmaceuticals must be produced safely and at a
Koki Obara, marketing manager, Asahi Kasei Medical, delves into the current biopharmaceutical environment, the critical role of virus removal filters, and how Planova FG1 stands to impact the development and production of biopharmaceuticals.
lower cost. Additionally, the manufacturing processes must also adhere to environmental conservation efforts.
Companies are increasingly utilising existing infrastructures and working to develop sustainable processes to minimise environmental impact, aligning biopharmaceutical production with Sustainable
Development Goals (SDGs).
THE ROLE OF VIRUS REMOVAL FILTERS
VF are essential for biopharmaceutical production, serving as the final defense in ensuring product safety. These systems are responsible for removing potential viral contaminants from medications before they reach patients,
safeguarding their health.
The recently revised ICH guidelines clearly state the Log Reduction Value (LRV) of effective virus removal and inactivation processes, reflecting the trend towards strengthening global safety standards. Meeting these stringent demands requires improvements in existing VF processes to ensure compliance and maintain patient trust.
VF operations involve multiple steps, from initial setup to filtration, followed by post-use integrity testing. These steps can extend over an entire day, creating bottlenecks in production. Any reduction in time spent in these stages can significantly enhance productivity, allowing manufacturers to bring products to market more quickly and efficiently.
INTRODUCING PLANOVA FG1: PROMISE OF UNRIVALED PERFORMANCE
Planova FG1 represents an advancement in the realm of virus filtration. It embodies two attributes critical to biopharmaceutical manufacturing: reliable and rapid.
Reliable: Planova FG1 ensures viral safety in various process conditions as highlighted below, confirming its robustness and reliability.
In addition, Planova FG1 is compatible with SIP (Sterilisation-In-Place) and CIP
(Clean-In-Place) processes within stainless steel facilities, broadening its applicability across various manufacturing setups.
Rapid: Planova FG1 boasts a significantly higher filtration speed compared to its predecessors and other high flux filters on the market, potentially contributing to reducing filtration time as demonstrated below. This speed not only enhances manufacturing throughput but also allows flexibility in production scheduling, enabling quicker turnaround of the manufacturing floor.
In consideration of the environmental impact mentioned above, Planova FG1 is shipped sterilised and prewetted, reducing time and water
usually needed when preparing for filtration.
CONCLUSION
The introduction of Planova FG1 into the biopharmaceutical manufacturing sector offers a beacon of innovation and progress. These filters will ensure that high standards of safety are maintained without compromising the efficiency and cost-effectiveness of
production processes.
Planova FG1 stands to become a key component in aligning the goals of patient safety, cost reduction and environmental responsibility. By reliably and rapidly advancing the virus filtration process, Planova FG1 enhances the overall efficiency of biopharmaceutical manufacturing. It thus supports the broader mission of making
Biosimilars are emerging as coste ective alternatives to existing biopharmaceuticals, driving down prices and expanding access.
advanced therapies accessible to everyone, especially those in underserved communities, further propelling the democratisation of healthcare.
In conclusion, Planova FG1’s development is a testament to innovation’s potential in addressing both existing and emerging challenges in the biopharmaceutical industry. By prioritising safety, efficiency and environmental sustainability, Planova FG1 not only enhances current manufacturing processes but also sets a new standard for future developments. As such, Planova FG1 is poised to make significant contributions to the evolution of biopharmaceuticals, ultimately improving patient outcomes and expanding global access to life-changing therapies.
Niall Balfour, chief executive officer, Tower Cold Chain examines the growing importance of measurable sustainability in temperature-controlled logistics, highlighting data-driven strategies and innovations that balance environmental goals with operational efficiency.
In today’s data-driven world, the measurement of sustainability efforts has become a critical priority –particularly in the pharmaceutical and life sciences sectors, where data-led decision-making can underpin success. The ability to demonstrate genuine sustainable practices is no longer optional for temperaturecontrolled container manufacturers, it is now a necessity.
Traditionally, products in this field have always been selected based on reliability and performance. However, sustainability credentials are now also an essential criterion, shaping choices on long-term partnerships in the supply chain. As the industry grows, the need for transparent, verifiable claims becomes all the more important to avoid the pitfalls of greenwashing.
PRIORITISING REUSABILITY
A significant way to improve sustainability within temperature-controlled logistics is simply through the use of fully reusable containers. Unlike single-use or semi-reusable containers, reusable options represent a tangible step toward reducing a company’s carbon footprint. Although single-use containers may offer some cost advantages and convenience, their environmental impact can be understandably hard to justify and measure in an era of heightened responsibility.
Sustainability that counts:
THE FUTURE OF TEMPERATURE-CONTROLLED LOGISTICS
Reusable containers, often designed to last over 15 years, are built with durability and sustainability at the forefront. These units can be cleaned, sterilised, and quality-assured time and time again for repeated use, significantly cutting down on packaging waste and reducing environmental strain. It is this robustness in manufacture that enables reusable containers to withstand the rigour of repeated transportation while maintaining quality and reliability.
In contrast, single-use containers are typically designed to be lightweight and affordable – exactly what is needed for one-time use. However, this compromises their long-term viability. Their disposal often leads to environmental challenges, particularly in regions where waste management regulations are inconsistently enforced and where the product’s end-of-life plan cannot be guaranteed, meaning these containers can still often end up in landfills.
Even some semi-reusable container options, despite offering a middle-ground solution, come with the caveat of component replacement and continued maintenance, which creates a dilemma of priorities between cost, efficiency, sustainability and performance.
LEVERAGING HUB NETWORKS
An often overlooked strategy for enhancing sustainability in pharmaceutical logistics is leveraging a global hub
network. This approach allows manufacturers to minimise the distance traveled by containers during return logistics, directly contributing to lower carbon emissions. By selecting a container provider with a comprehensive and strategically positioned network, pharmaceutical companies can optimise their supply chains, ensuring that containers are transported the shortest possible distance for their return, thus reducing their environmental footprint.
HARNESSING DIGITAL TOOLS
Leading container manufacturers are already optimising their hub networks for this very reason. For example, Tower Cold Chain has introduced a “Click and Collect” service for its reusable, small box containers. This system empowers customers to initiate a seamless collection process by simply scanning a QR code on the container. The ease of this technology not only reduces administrative overhead but also streamlines the return logistics process. These optimised return paths reduce fuel consumption and associated emissions, emphasising how logistical efficiency can align with sustainability goals. Hub networks and collection and return services highlight the significant potential for emission reduction by avoiding excess movements and simplifying logistics management. By embedding these advanced systems into their operations, pharmaceutical manufacturers can more effectively track, manage and report on their carbon reduction efforts - reinforcing their commitment to environmentally conscious practices while enhancing the overall efficiency and reliability of their logistics networks.
As sustainability becomes an increasing industry focus, technological advancements within the supply chain are also playing a pivotal role in achieving environmental goals. Digital tools aid in a multitude of ways, from inventory management to lane simulation and temperature logging. These technologies therefore enhance overall operational efficiency, preventing product damage, misplacement, or misroutingeach contributing to reduced waste and optimised use of resources.
One increasingly popular tool in this context is carbon footprint calculators. These calculators provide a transparent assessment of the emissions associated with specific pharmaceutical shipments, allowing logistics teams to make informed decisions. By offering detailed analyses, companies can identify opportunities to reduce emissions and select the most sustainable container solutions.
For instance, Tower Cold Chain recently launched a carbon calculator offering as part of its “Sustainability Hub”, which showcases the company’s sustainability initiatives and provides information about the tools the company offers for customers to evaluate the sustainability of their logistics. These include the carbon calculator, engineering consultancy and the company’s own ‘Control Centre’ where
customers have real-time visibility and comprehensive monitoring and tracking, ensuring greater control and efficiency.
To access the calculator, customers can reach out to their regional sales team, where they will evaluate the container type, PCM (phase change material) plate temperatures, transportation mode, travel distance, and payload weight. The tool therefore empowers pharmaceutical manufacturers with valuable insights, making it easier to choose the solutions that best align with their sustainability strategies.
As sustainability expectations continue to evolve, the temperature-controlled logistics industry must innovate and adapt to provide measurable, credible sustainability outcomes. The emphasis on reusability, a broad hub network and digital tools demonstrates the sector’s capability to align operational efficiency with environmental responsibility.
Proving sustainability claims through data-driven evidence and helpful tools builds trust and adds value for customers striving to meet their own environmental targets. By adopting comprehensive strategies that include reusable solutions, efficient logistics frameworks, and innovative technology, the industry can work together to pave the way for continuous sustainability improvements.
Hub networks and collection and return services highlight the potential for emission reduction by avoiding excess movements and simpli ing logistics management.
Drive leads and engagement with a EUROPEAN PHARMACEUTICAL MANUFACTURER WEBINAR
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Webinars offer a multi-layered marketing outcome, enabling you to tell your story to a global audience, define your organisation as a thought leader and simultaneously deliver a healthy number of leads for your sales team to get to work on.
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To discuss how you can leverage our audience and marketing channels with a Webinar contact our Sales team: Robert Anderton: +44 (0) 1244 952 359
robert.anderton@rapidnews.com
Advanced microbial ID system ACCELERATES PRODUCT RELEASE TESTING
Drug development brings an inherent risk of product contamination as many active pharmaceutical ingredients (APIs) and excipients support microbial growth. Specialised microbial testing is essential to prevent bacterial and fungal contamination posing a serious threat to drug efficacy and patient safety, with the potential for painstaking, time-consuming and costly follow-up action.
The Food and Drug Administration (FDA) Enforcement Report Program reports that 40% of the 1,712 product recalls associated with contamination in the USA between 2012 and 2023, were the result of microbial contamination. Manufacturers in this highly regulated sector need effective microbial monitoring and contamination control strategies compliant with good manufacturing practices (GMP) – which are often outsourced to specialist laboratories.
Stefan
Karl, CEO, Mikrobiologisches Prüflabor GmbH, Innsbruck (L) and Olaf Degen, director industry microbiology, Bruker Microbiology & Infection Diagnostics (R).
TIME CHALLENGES ASSOCIATED WITH GENOMIC SEQUENCING
Fast and efficient product release testing and environmental monitoring are critical. Traditional contaminant detection uses genomic sequencing - an effective but typically time and cost-intensive method. With mounting pressure to cut drug development time and cost, the industry needs a quicker and simpler solution that does not compromise data integrity.
A NEW APPROACH TO PRODUCT RELEASE TESTING
A new microbial identification system implemented at the MPL, based on Matrix-Assisted Laser Desorption/ Ionization Time-Of-Flight Mass Spectrometry (MALDI-TOF MS), has brought down the time of identification testing for product release from days to minutes. Validated results are delivered from a small amount of culture using a comprehensive reference database.
It used to take anywhere between four hours and 20 hours to perform reliable identification testing for product release; more if additional sample preparation activity was needed, which could easily add one or two extra days. MPL’s new identification system has brought the process down from days to minutes – literally a few minutes per sample.
The system can also detect fungal contamination, less common than bacterial contamination, but still with a significant impact on the manufacturing process, the product, and the patient. Fungal contamination has been subject to increased scrutiny due to the potential for severe fungal disease outbreaks triggered by contaminated pharmaceuticals.
Identifying moulds and multicellular fungi presents a challenge for microbiologists, with filamentous fungi being particularly hard to identify. Many global laboratories identify fungi using manual processes which are highly subjective and inherently nonstandardised. The new approach offers a standardised analysis of a wide range of fungal contaminants that minimises error, increases
efficiency and allows for reliable cross-referencing with morphological and microscopic assessments.
CONCLUSION
New technological innovations are helping minimise the risk of contamination in the drug development process, while providing an accelerated and standardised product testing model. The move away from genomic methods provides pharma developers with fast, accurate and reproducible data to bring safe new drugs to market more quickly and costeffectively.
What new products or innovations did your company showcase at BIO 2024?
At BIO 2024, Purolite announced a major product innovation in affinity chromatography. Our new protein A resin, DurA Cycle A50, promises to address key challenges facing the biopharmaceutical industry. Our new offering represents the culmination of extensive research and development, and collaboration with top experts in the field, and we were delighted with the significant impact it has made at the show.
BIO International provides the perfect platform for showcasing this major product launch to a global audience of industry leaders, innovators, and stakeholders. With its networking opportunities, educational sessions, and access to potential partners and customers, the event offered us a prime opportunity to generate buzz, build brand awareness, and drive engagement around our new solution.
Attending the event also aligned perfectly with our strategic objectives of expanding our market presence, forging valuable partnerships, and staying at the forefront of industry trends and developments. By taking part in this event, we have demonstrated our commitment to driving positive change within the sector.
PUROLITE: An Interview With Felix Solamo
We caught up with Purolite’s Felix Solamo to look back on Bio International 2024 and what it meant for the company.
What has Purolite achieved from the event?
The biopharmaceutical industry is very much a people-focused industry, and collaboration is key, so we’re always looking for new ways to engage with delegates who attend BIO International and nurture relationships across the value chain. There’s nothing like meeting people face-to-face to discuss projects and help build deeper, more meaningful relationships. This way attendees of BIO get a real feel for who we are, the innovative solutions we provide, and the culture of our business.
The main objectives for participating in BIO include engaging with current customers, meeting prospective new customers interested in our solutions, and presenting Ecolab’s capabilities and investments in Purolite. The
event is a regular fixture on Purolite’s events calendar, presenting an excellent opportunity to introduce our offering to a broader audience
What challenges are currently facing the pharmaceutical market, and how is your organisation addressing them?
Sustainability has become a critical consideration in recent years. Purolite is focused on how decisions made during
downstream processing can help mitigate environmental impacts, conserve resources, and ensure economic viability while meeting sustainabilityrelated regulatory requirements. To address these challenges, we are implementing innovative practices and technologies that minimise waste and energy consumption, thereby reducing our environmental footprint.
Can you discuss any plans for expansion or market growth in the pipeline?
In response to customer and market needs, Ecolab has not only developed innovative new products but has invested in additional manufacturing capacity to increase global resin supply and provide increased supply security.
Through a heavy and continued investment from Ecolab, we are investing in dualcontinent supply capabilities. This means that as our customers’ production scales and grows, we can provide the necessary volumes to our global customer base from strategically located manufacturing locations. This enhances supply chain reliability - especially during challenging times, such as the pandemic - and enables Purolite to strategically locate its manufacturing operations close to key customers.
This investment into the additional manufacturing facility will enable Purolite to continue to meet market demand.
BIO International provides the perfect pla orm for showcasing this major product launch to a global audience of industry leaders, innovators, and stakeholders.
HOW READY ARE YOU?
Annex 1 and the Impact of Primary Packaging
While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe when it came into force on 25 August 2023. At this point, entire supply chains entered a new era defined by a raft of updated rules, all of which are ultimately focused on enhancing levels of public health protection. Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and patient safety.
For a pharmaceutical company to meet their CCS responsibilities, therefore, they must rely on the support of a supply partner capable of addressing both aspects of process and people. Only then can they receive full assurance that primary packaging components do not only comply with the specific rigorous demands of EU GMP Annex 1 but are managed via a holistic approach that supports continual improvement into the future.
WHAT IS ANNEX 1?
Annex 1 provides technical guidance on the principles and guidelines of good manufacturing practice (GMP) for medicinal products for human use and veterinary use. A deliberate and well-documented contamination control strategy is one of the new focuses in the EU GMP Annex I revision. The 2023 GMP Annex 1 revision is
Niamh Bissett, director, operations, PMO, West Pharmaceutical Services
causing a seismic shift in drug manufacturing. The regulations have more than tripled in length with this revision, and they contain over 30 references to primary packaging material alone.
WHAT ARE THE IMPLICATIONS FOR PRIMARY PACKAGING?
Specifically, section 8.2 in Annex 1 defines “Primary packaging containers and components should be cleaned using validated processes to ensure that particulate, pyrogen and bioburden contamination is appropriately controlled.” The evolving regulatory landscape requires pharma and biotech companies to partner with a true expert who can help them navigate the new regulations successfully. Supplier components may be part of the overarching sterile manufacturing process and contamination control strategy; however, it is the responsibility of the finished product (drug/biologic) manufacturer to comply with the regulation.
WHAT DOES A GOOD CCS LOOK LIKE?
The holistic approach to CCS required by EU GMP Annex 1 considers primary packaging components and the wider supply chain vital to compliance. West has a comprehensive contamination control strategy for limiting biological, loose, and embedded contamination throughout the stages of design, installation, testing,
and manufacturing at our sites. We also have an ongoing internal initiative to assess the manufacturing controls within our facilities along with our current manufacturing process, facility, equipment, and workflows against the requirements of EU GMP Annex 1. It is our goal to continually evaluate and evolve our contamination control strategy.
WHAT ARE THE KEY CONSIDERATIONS FOR ASSESSING COMPONENTS IN ANNEX 1?
There are four key considerations to consider for Annex 1 readiness:
1. Product: Analysing the current quality level of packaging components, understanding the specifications for particulate, bioburden, and endotoxins, and if a tighter specification is required.
2. Process (manufacturing design): where is the product sterilised- is in house or with the component supplier? How will components be introduced on the fill/finish line? Will sealing occur in an aseptic environment?
3. Protection (CCI): Is there a robust understanding of the factors that will impact the CCI? Is there a monitoring and testing plan in place over the life of the drug product? and finally,
e holistic approach to CCS required by EU GMP Annex 1 considers primary packaging components and the wider supply chain vital to compliance.
4. Does your supplier have a Contamination Control Strategy (CCS): and are they focused on continual improvement? What documentation is available to support your CCS?
Anew survey from Censuswide with 100 senior regulatory professionals in US pharma and biopharma organisations, confirms that regulatory obligations have soared over the last five years, with three in five (60%) saying the scale of increase is far beyond that of normal company growth - a trend set to continue over the next five years.
Specific regulatory process challenges include excessive time spent producing submissions/dossiers; maintaining labelling compliance; inputting data/ documents into IT systems; verifying submission correctness/completeness; performing regulatory impact assessments; and locating data or documents in existing IT systems. More than a quarter of the research base indicated each of these issues. Further barriers to efficiency include responding to agency queries; inadequacy of current IT systems; and time lost to data quality checks/assessing submission readiness.
Regulatory AI appetites are G R O W I N G, new survey suggests
Pharma regulatory workloads are now outpacing company growth, fuelling investment in AI-boosted regulatory process automation. ArisGlobal’s director of product management, Agnes Cwienczek, reports on these and other top-level findings from a new Censuswide survey of senior life sciences regulatory professionals.
A lack of qualified people was much less likely to be registered as a concern, suggesting that preferred strategies do not involve allocating more people to processing regulatory workloads. Rather, pharma and biopharma regulatory functions are looking to smarter use of technology.
Although specialist AI tools and applications for targeted regulatory use cases are only now coming to market, over a third (35%) of respondents claimed to be using AI for regulatory purposes in some form already, while 42% plan
to invest in the next 18 months. A further 15% are looking at a timeframe beyond that, but do also have plans to roll out AI within the regulatory function.
While no respondents were ignoring AI entirely, 6% were not yet convinced by the technology’s potential for regulatory purposes and had no current plans to invest in AI.
CAUSES OF HESITATION
Asked what might be holding back initial or further investment in AI for Regulatory purposes, respondents most commonly cited outdated existing IT landscapes (45%); a belief that risks currently outweigh the benefits (44%); and inadequate availability/quality/consistency of data or content resources to derive the value from AI (42%).
In addition, 39% of respondents felt the technology remained too immature/unproven; similarly, that the tools do not exist today to address their particular regulatory pain points. 16% blamed a lack of trust in AI currently. This was ahead of budget challenges: only 15% named a lack of budget as a barrier to AI investment.
The research also identified the factors most likely to convert interest and inertia into active projects. Here, respondents most commonly cited the discovery that their competitors are using the technology (41%); soaring workloads/continued resource pressures (40%); advances with the technology/ its being more mature and proven (36%); the availability of specific tools geared to the tasks regulatory teams find most challenging or expensive (35%); and relevant IT systems becoming easier and more affordable to deploy (33%).
Beyond those drivers, 31% said updating their upgrades
to existing IT set-ups (making it possible to use AI reliably) would prompt investment. Endorsement or recommendation of AI by regulators would inspire investment also for just under a third of respondents.
REGULATORY AI AIDS WILL BECOME PARAMOUNT
To conclude, the survey asked about respondents’ expectations of AI in a regulatory context over the longer term. Almost half (48%) of respondents agreed that, in time, AI would transform a lot of routine regulatory work and considerably streamline processes. Over 2 in 5 (43%) felt AI would drive up accuracy and quality in the information they produce for regulators and patients. Almost 2 in 5 (39%) respondents believed AI would be critical to the regulatory function’s ability to keep pace with market demands. And over a third (35%) of respondents agreed that AI would save a lot of time and money.
This supports the finding above that pain points are multiple and diverse, and suggests that ideally an investment in the right AI capability should address all of these challenges over time.
The full research report is available here: https://www.arisglobal. com/resources/regulatory-industry-survey/
FACTS & FIGURES
• Over 90% of respondents see AI’s growing acceptance in automating the intake of Health Authority interactions, performing regulatory impact assessments and suggesting improvements to submissions.
• Over a third of respondents say they are using AI for regulatory purposes in some form already, while 42% say they plan to invest in the next 18 months.
• 18% indicated that the availability of a new budget would allow for AI investment.
• 6% said that they were not yet convinced by the technology’s potential for regulatory purposes and had no plans to invest in AI.
Almost half of respondents agreed that AI would transform a lot of routine regulatory work and considerably streamline processes and almost 2 in 5 respondents believed AI would be critical to the regulatory nction’s ability to keep pace with market demands.
LEADERS IN PHARMA:
Urmi Prasad Richardson, president of EMEA at Thermo Fisher Scientific.
In the latest episode of MedTalk, we delve into the journey of leadership in the pharmaceutical industry with Urmi Prasad Richardson, president of EMEA at Thermo Fisher Scientific. The conversation offers a compelling insight into what it takes to lead in such a transformative and challenging sector. Here’s an excerpt from this inspiring discussion, highlighting Urmi’s journey and leadership philosophy.
Urmi Prasad Richardson describes herself as a “recovering scientist who crossed over to the dark side of business.” With over 25 years in biotech, biopharma, and life sciences, her career has been defined by bridging the gap between scientific innovation and practical application. “I’ve always been fascinated by how we translate scientific breakthroughs into sustainable clinical use to improve patient outcomes,” she shares.
Having started her journey as a biochemical engineer researching recombinant antibodies before they were called monoclonal antibodies, Urmi later pursued an MBA to “learn the language of business.” Her career path includes stints at industry giants like Novartis and Roche, as well as smaller biotech firms. Now at Thermo Fisher, she focuses on leveraging a vast portfolio of technologies to create cohesive solutions for academic institutions, biotech, biopharma, and governments.
LEADERSHIP LESSONS FROM A GLOBAL CHILDHOOD
Growing up across six countries by the age of 16, Urmi attributes much of her leadership style to her multicultural upbringing. “When you’re the new kid in school every couple of years, you learn how to listen, recognise patterns, and connect with people from diverse backgrounds,” she explains.
This foundation in empathy and adaptability became the cornerstone of her leadership philosophy. “Listening and understanding what drives or concerns others is key to empowering people and creating effective teams. Despite the differences, there’s often more that connects us than divides us,” she emphasises.
SUSTAINABILITY AT THE CORE
Sustainability is not just a buzzword for Thermo Fisher; it’s deeply embedded in its mission. Urmi details the ambitious goals her company has set: achieving net-zero emissions by 2050, reducing Scope 1 and 2 emissions by 50% by 2030, and powering all U.S. sites with renewable electricity by 2026. “These targets are not optional; they’re essential for supporting a healthier planet and advancing global public health,” she notes.
Urmi acknowledges that aligning such a large organisation behind these goals is complex, but collaboration with customers and regulatory bodies accelerates the process. “Our partners’ commitments drive us to act proactively and create solutions that are impactful not just for today, but for the future,” she adds.
INSPIRING THE NEXT GENERATION
Urmi’s advice to aspiring leaders? “Stay curious, take calculated risks, and listen deeply.” She underscores the importance of empathy paired with accountability: “Empathy helps you connect, but accountability ensures you act.” Her dedication to mentorship and advocacy for diversity in STEM shines through as she reflects on her own journey: “Being visible and sharing your story inspires others to see what’s possible.”
For the full conversation with Urmi Prasad Richardson, including insights on innovation, leadership challenges, and more, scan the QR code to listen to the podcast episode.
Talking points
NHS LAUNCHES ANTI-SMOKING PILL TO HELP THOUSANDS QUIT
As part of the UK government’s efforts to create a smoke-free generation, the National Health Service (NHS) England is rolling out a new and improved pill to help people stop smoking, giving thousands of smokers a better chance to quit for good.
The smoking cessation pill, known as Varenicline, will be offered to around 85,000 smokers in England to help them kick the habit alongside behavioural support, according to a November press release.
NHS England states that the tablet is as effective as vapes in helping people stop smoking and performs even better than nicotine-replacement gum or patches. About 1 in 4 people who take varenicline with behavioural support manage to quit for at least six months, the NHS reported.
Varenicline works by reducing nicotine cravings by blocking its effect on the brain as well as easing withdrawal symptoms like irritability and trouble sleeping. The pharmaceutical company Teva UK will
manufacture the drug for the NHS.
A decline in smoking rates over the past couple of decades means that only 11.6% of adults in England still smoke – about 6 million people. There were more than 400,000 hospital admissions in England linked to smoking last year, alongside 74,600 smoking-related deaths in the UK in 2019, accounting for around 15% of all deaths that year. This rollout ties in with the UK government’s new Tobacco and Vapes Bill, which aims to gradually phase out smoking as it expects to curb the £2.5bn spent each year on the NHS treating smoking-related health issues.
“Prevention is better than cure,” added Wes Streeting, health and social care secretary.
“The rollout of this pill can save the NHS millions of pounds, save appointments to help other patients be seen faster, and save lives. Taken alongside our tobacco and vapes bill, the government and NHS are building a healthy society to help power a healthy economy.”
UK medicines manufacturing skills centre welcomes UK £520 million Budget
Some of the UK’s leading academics and industry professionals welcomed Rachel Reeves’ recent announcement of £520 million to develop the UK’s medicine manufacturing capabilities, but say creating a trained workforce must be a priority.
“This announcement in the Budget to support life sciences is a welcome step for the UK medicines manufacturing sector,” says Professor Ivan Wall – co-director of Resilience, the UK’s fi rst Medicines Manufacturing Skills Centre of Excellence. “However, there is an acute skills shortage that must be addressed to ensure we have trained staff ready to work in the sector.”
Resilience was set up recently to address the acute skills shortage faced by the medicines manufacturing industry in the UK. It is a £4.5 million, two-year project funded by the Offi ce for Life
Sciences, part of the UK Government’s Department for Science, Innovation & Technology, and managed through Innovate UK.
The fi rst wave of investments from the Budget will increase manufacturing capacity to ensure the UK can respond to future healthcare emergencies and adapt to the manufacturing demands of new treatment types. This will increase the country’s physical capacity to make medicines.
Resilience will create and deliver new training courses for industry, the NHS and education providers, addressing key sector priorities, including digital technology, artifi cial intelligence, data analysis and environmental sustainability.
Check out EPM’s full chat with Professor Ivan Wall about the Resilience project at pharmaceuticalmanufacturer. media.
