FROM
MOLECULE TO MEDICINE
Transforming the way pharmaceuticals are made with a simplified, end-to-end supply chain for companies of all sizes, Thermo Fisher Scientific is committed to offering its clients a track record of quality and performance through the Patheon™ pharma services brand. We speak to Kym Baker, General Manager of the company’s Brisbane site, to learn more
Writer: Lauren Kania | Project Manager: Cameron Lawrence
FROM MOLECULE TO MEDICINE
Helping customers bring medicine to patients requires science, technology, and worldclass expertise.
This necessity is certainly recognised by Thermo Fisher Scientific (Thermo Fisher) at its Australian site in Brisbane, specifically in its state-of-the-art facility specialising in clinical and commercial manufacturing and single-use biologics technology.
Thermo Fisher is helping to transform the way pharmaceuticals are made with a simplified, end-toend supply chain for pharmaceutical and biopharmaceutical firms of all sizes through its Patheon™ brand.
By offering a comprehensive range of services spanning phases and scales as a contract development and manufacturing organisation (CDMO), Thermo Fisher prides itself on a track record of high quality and on-time performance.
“Thermo Fisher provides clinical and commercial biopharmaceutical production as well as analytical services, process validation, technical transfer, and commercialisation services,” introduces Kym Baker, General Manager of the Thermo Fisher’s Brisbane site.
Additionally, the company is one of a small number of mammalian cell biomanufacturing companies in Australia that meets global regulatory standards with the Therapeutic Goods Administration (TGA), Food and Drug Administration (FDA), Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Evaluation Agency (EMEA), and
Korean MHRA.
Thermo Fisher is also the first company in the country to contract manufacture multiple biotherapeutic drugs on a commercial scale using mammalian cell lines.
“Our ability to undertake sovereign manufacturing of medicinal products locally is important in Australia as it contributes to allowing both regional and overseas researchers and companies access to the country’s attractive R&D tax incentive and the ability to leverage the Clinical Trial Notification (CTN) scheme, which can significantly help to reduce the timelines to get to clinic and, ultimately, approval,” insights Baker.
Alongside these benefits, it also contributes to providing greater control of the production process, reducing costs, and heralds the return of Australian life scientists and bioengineers, all helping to ensure the continued innovation and advancement of the nation’s healthcare manufacturing profession.
ON A MISSION TO SAVE LIVES
Inspired by her father to take up chemical engineering, a field that was primarily dominated by men in the 1970s and 80s, Baker knew that healthcare was the career for her from a young age and was determined to work hard to make a difference with
“OUR BIGGEST ASSET AND INVESTMENT ARE OUR PEOPLE, AND WE ARE CONTINUING TO WORK ON NEW AND EXPANDED DEVELOPMENT PATHWAYS TO SUPPORT THEM”
– KYM BAKER, GENERAL MANAGER- BRISBANE SITE, THERMO FISHER SCIENTIFIC
her passion and ambitions.
“Roll back time to the first BioTech boom in the 1980s, and I aspired to find a cure for cancer. I started university enrolling in the first ever BioTech degree and have never looked back!” she enthuses.
“Working in a CDMO, I now get to make treatments for cancer, rheumatoid arthritis, immunological therapies, and much more in both the clinical and commercial industry. I like to think my dreams have been realised as I actively play a part in many positive patient health journeys.”
As healthcare manufacturing is notoriously one of the most rapidly changing industries across the world, with new technologies, advancements, and medicines constantly being developed to better treat the public, there are always new hurdles to overcome.
THERMO FISHER’S SPECIALISED CAPABILITIES
• Optimised production from preclinical to commercial launch, including commercial supply.
• Single-use technology and flexible facility design.
• Expertise in most process modes for commercial cell lines.
• Mobile equipment to match process needs.
• Upstream and downstream technologies enabling lower investment costs and scale-up risks, reduced labour costs, and quicker process times, which help contribute to a shorter time to market.
• Experience with the majority of commercial cell lines.
Quantity Meets Quality
The race to get advanced therapies to market continues to intensify, placing pressure on manufacturing to streamline workflows, test faster, and release without compromising quality.
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Leverage our suite of QC and biosafety testing products and services to quickly deliver safe therapeutics to patients.
While these challenges may seem intimidating to some, Thermo Fisher faces them head-on with the knowledge that its state-ofthe-art facilities, performance, and regulatory compliance record allow it to navigate compressed timelines and develop solutions to provide a dependable, high-quality supply to clients.
Most recently, the COVID-19 pandemic posed challenges to sectors across the entire globe. However, for healthcare manufacturing, it provided both opportunities and momentum.
“The support for healthcare development and innovation increased, and confidence in STEM collaborations across government, industry, and academia to transform the industry continues,” expands Baker.
“While the supply chain to support this increased manufacturing demand was very challenging during
the pandemic, we are seeing a return to normal, enabling improved speed to market that is closer to prepandemic levels.”
END-TO-END SOLUTIONS
Thermo Fisher has worked diligently over the years and gained a reputation for reliability, highquality service, and dedication to its partnerships.
By putting quality at the core of everything it does, Thermo Fisher has earned the trust of clients around the world, and those companies have, in turn, secured millions of medicinal doses for their patients.
While the company’s ability to generate time and cost efficiencies has earned it new business and customers across the industry, Thermo Fisher’s commitment to quality continues to build its client relationships and strategic partnerships.
Additionally, the company
HEALTHCARE OUTLOOK: AS A CDMO FOR BIOTHERAPEUTIC DRUG SUBSTANCE MANUFACTURING, HOW CRITICAL IS YOUR SUPPLY CHAIN?
KYM BAKER, GENERAL MANAGER - BRISBANE SITE:
“We have approximately 2,500 different cGMP-grade raw materials which require sourcing, procurement, delivery, testing, and storage in our 4,000 sqm warehouse prior to kitting, transport, and use in cGMP manufacturing or quality control.
“Add in the logistics of shipping thousands of samples and hundreds of batch shipments, and it becomes a complex operational hub.
“These starting materials are sourced from a multitude of suppliers, each of which must meet our strict quality standards. Therefore, the relationships with our key suppliers are dynamic and collaborative.”
highlights the consistent pursuit of improvement, proactively seeking out opportunities in order to prevent problems before they occur and regularly examining and refining its systems and processes.
“Within the biotherapeutic space, we offer very flexible services, which support a wide range of global client needs from early clinical stage through to commercial production,” details Baker.
“Offering both technical expertise combined with exceptional quality, we can support a client’s clinical to commercial manufacturing journey.”
A DIVERSE FUTURE IS A SUCCESSFUL FUTURE
Thermo Fisher recognises the critical importance of a diverse, inclusive working environment to any company’s innovative future and is proud to have a multicultural workforce, with more than 35 nationalities represented on site and approximately 50 percent female representation across most aspects of the business, including management.
“OUR STAFF ARE REMINDED EVERY DAY AS THEY WALK THROUGH THE HOSPITAL GROUNDS WHY WE EXIST - WE ARE HERE TO MAKE LIFE-SAVING MEDICINES TO HELP OUR CLIENTS’ PATIENTS”
– KYM BAKER, GENERAL MANAGER- BRISBANE SITE, THERMO FISHER SCIENTIFIC
“The diversity of our team pays dividends, not just from a level of cultural understanding but also by generating diversity of thought, which keeps us agile and progressive,” asserts Baker.
The importance of this was exemplified when Thermo Fisher needed to meet a client’s tight timeline during the transition from another manufacturing provider.
Thermo Fisher had a native speaker attend the client’s plant in Asia and translate batch records by hand to facilitate an accelerated technical transfer to Thermo Fisher’s site, ultimately contributing to the continued supply of the drug.
“Our client relationships are personalised and tailored to meet their demands. Having a level of diverse cultural experience and appreciation helps us to please our equally diverse clientele,” expands Baker.
This focus on the vast benefits of diversity is parallel to the company’s culture and Mission to enable customers to make the world
healthier, cleaner, and safer.
“We have a culture of collaboration, trust and solution orientation to ensure our clients are successful. We are a large family, all pulling in the same direction. I am immensely proud of the team and what they achieve every day,” concludes Baker.
