CPHI Frankfurt Day Three newsletter

DAY THREE 3rd November

NEWSLETTER Complex lipids for sophisticated xRNA therapeutics

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ordenPharma’s custom and standard lipids enable pharma to encapsulate advanced xRNA therapeutics.

One of the more popular enabling technologies in pharma development today are lipids and Lipid NanoParticles (LNPs). The recent success of mRNA vaccines is partly due to innovation in LNP

Thermo Fisher Scientific to expand clinical research laboratory in Kentucky

delivery systems. These systems work because, not only do they express the mRNA-encoded immunogen after intramuscular injection, but they also play a key role as adjuvants and in vaccine reactogenicity.

Robust platforms for development, lipids and LNPs have become increasingly complex. This, in turn, is driving innovation by chemists and process engineers seeking to introduce sustainable, costefficient ways to produce these critical drug substances at scales suitable to development and commercialisation needs.1

The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, today announced plans to invest $59 million to significantly expand its laboratory operations in Highland Heights, Kentucky, helping customers deliver life-changing medicines to patients. The current facility, which includes central lab and biomarker operations, provides biopharma customers with high-quality laboratory services to accelerate drug development. Much of the expansion involves adding to the business’ sample management and testing

capacity to support new therapeutics, including vaccines and cell and gene therapy products.

The current 71,600-squarefoot operation will grow to 114,000 square feet and be completed in stages by the end of 2024, creating 200 new jobs over the next five years. The current operation employs nearly 650 Ph.D.-level scientists, analytical laboratory staff and other scientific and support professionals.

To read more go to: https://www. lskh.digital/news/thermo-fisherscientific-to-expand-clinicalresearch-laboratory-in-kentucky/

To read more go to: https://www. lskh.digital/article/complex-lipidsfor-sophisticated-xrna-therapeutics/

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DAY THREE - NEWSLETTER

CDMOs + energy costs + raw costs = ?

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By Kenneth Drew, Ph.D,Vice-President at Flamma USA

ver the past several years, our world has changed more than we are used to. Much of this is expected, but much of it is not.

Nobody was prepared for a pandemic regardless of what they say today. The fallout from the pandemic is still playing out with supply chain shortages and nations struggling to deal with the aftermath across many industries.

Adding the unprovoked invasion of Ukraine by Russia has provided a ripple effect that now has carried over to CDMOs. The rise of inflation has caused great pain across the globe, specifically in Europe and North America. It is very easy to see that everything costs more today.

For example, the cost of natural gas and electricity has risen dramatically over the past few years. Depending on where you look for your data, energy costs

have increased anywhere from 3X to 10X when compared to 2020.

This has a ‘trickle down’ effect to almost everything.

Specifically, those CDMOs that produce APIs have been hit hard.

Recent reviews of pricing models that were put into place two to four years ago for quoting purposes are now being shown to be off by huge amounts. Many pharmaceutical drugs made today come from very sophisticated starting materials that can often be 10-20 steps to make. Since the starting materials are so sophisticated, the lead times for these APIs could be well over 12 months.

To read more go to: https://www. chemicalsknowledgehub.com/ article/cdmos-energy-costs-rawcosts/

Interview with Catalent’s President and Chief Executive Officer, Alessandro Maselli Alessandro Maselli became Catalent’s President and Chief Executive Officer on July 1, 2022, and now heads a leading development and manufacturing company with a history going back over 90 years. Catalent enables its partners in pharmaceutical, biotech, and consumer health to optimise product development,

launch, and commercial supply of around 8,000 products to patients around the world. Each year, the company produces more than 80 billion doses of medicines and consumer health products for more than 1,200 customers.

To read more go to: https://www. lskh.digital/article/18430

Cingulate announces agreement with societal CDMO and provides clinical update Cingulate Inc., a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced it has executed a Master Services Agreement (MSA) with Societal CDMO, Inc., a bi-coastal contract development and manufacturing organization (CDMO) dedicated

to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development.

To read more go to: https://www. lskh.digital/news/cingulateannounces-agreement-with-societalcdmo-and-provides-clinical-update/

DAY THREE - NEWSLETTER

Cambrex to invest $16.5 Million in new R&D facility in Minneapolis, Minnesota and expansion in Charles City, Iowa

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ambrex today announced it is investing in a new, 21,000-square-foot research and development facility in Minneapolis, Minnesota, expanding its capacity for small molecule development and manufacturing. Strategically located near the Minneapolis–St. Paul Airport, the new facility will specialize in analytical and chemical development for pharmaceutical

drug candidates and will operate as an extension of Cambrex’s flagship facility in Charles City, Iowa. Cambrex is expected to add approximately 40 new jobs over the next 2-3 years at the new site in Minneapolis.

Cambrex will simultaneously launch a multi-phase, 9,000-squarefoot expansion and 21,000-squarefoot renovation project in Charles City, Iowa. The expansion will add

a new quality control laboratory and administrative office space, which will bring 40 new jobs at the site. The expansive renovations will enhance and modernize the existing quality control and research and development facilities. The Iowa Economic Development Authority (IEDA) board awarded the company tax benefits and $300,000 in direct financial assistance to support the

expansion through the High Quality Jobs (HQJ) program.

To read more go to: https://www. lskh.digital/news/cambrex-toinvest-16-5-million-in-new-rd-facilityin-minneapolis-minnesota-andexpansion-in-charles-city-iowa/

SIRIO launches two novel Curia celebrates groundGummies at CPHI Frankfurt breaking ceremony in Albuquerque SIRIO Pharma (SIRIO) – the global nutraceutical contract development and manufacturing organization (CDMO) – launches two new gummies at CPHI Frankfurt (Stand: 91D70). The new products are

formulated to help customers meet the growing demand for nutraceuticals that aid with sleep and stress, as well as boost the immune system.

Both newly created gummies will form part of the company’s growing ChewyVita® range and have been launched in time for the winter months, with production capacity and customization immediately available. The products, presented to customers for the first time at the event, were specifically developed by SIRIO’s large R&D department to offer superior taste, texture and visual appearance to rival formulations with similar ingredients.

To read more go to: https://www. lskh.digital/news/sirio-launchestwo-novel-gummies-at-cphifrankfurt/

Curia, a leading contract research, development and manufacturing organization, today hosted a ground-breaking ceremony to mark the beginning of construction of its expanded campus in Albuquerque, New Mexico. The additional space will house a new, advanced isolated high-speed fill-finish vial line – which includes biosafety level 2 (BSL-2) containment as well as two lyophilizers for the high-speed fill-finish line and an isolated flexible filling line for vials, syringes, and cartridges to support smaller-batch

advanced therapies.

“We are delighted to recognize the beginning of construction for this much-needed expansion in bioscientific capacity and capabilities,” said Curia Chairman and CEO, John Ratliff.

To read more go to: https://www. lskh.digital/news/curia-celebratesground-breaking-ceremony-inalbuquerque/

DAY THREE - NEWSLETTER The Knowledge Hub TV INTERVIEWS

Quotient Sciences Dr Asma Patel, Vice President

AMPAC an SK pharmteco Company - Jeff Butler, President

NEW! At CPHI Frankfurt we have met with Dr Asma Patel Vice President of Integrated Developmet at Quotient Sciences. In this engaging interview Asma talks about the team, their expertise, their recent expansions and much more.

NEW! At CPHI Frankfurt we had a brief chat with Jeff Butler President at AMPAC Fine Chemicals an SK pharmteco Company.

Find out in this interview what he had to say about investment in emerging technologies.

To see the whole interview go to: https://youtu.be/Z3xNBtHxbHo

To see the whole interview go to: https://youtu.be/1ETRZzYSX-Q

Hovione Marco Gil, SVP Sales and Marketing

Veranova - Niek Stapel, CEO

Here is our latest interview with Marco Gil, SVP Sales and Marketing at Hovione. We discussed their new manufacturing line dedicated to continuous tableting, their strategic partnership to market Zerion Pharma’s Dispersome technology and much more!

NEWS! Certainly another busy day at CPHI Frankfurt. Our team stopped at the Veranova stand to speak to Niek Stapel, CEO and find out more about the new brand!

To see the whole interview go to: https://youtu.be/mC0c9wd6vt0

To see the whole interview go to: https://youtu.be/NIRYT9TRNJc