Pharmaceutical Technology Europe- February 2023

Pharmaceutical Technology Europe- February 2023

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22 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook 2023 TADAMICHI - STOCK.ADOBE.COM T he relationship between pharmaceutical companies and the contract organizations that perform development and manufac- turing services comes with the necessary process of transferring intellectual information, processes, and product from one organization to an- other. Complex products such as biologics and mes- senger RNA (mRNA) vaccines come with additional challenges during the tech transfer process. To gain more insight on the complexities of transfer of pharmaceutical technology between contractors and sponsors, Pharmaceutical Technology spoke with Petra Dieterich, scientific leader, and Jeffrey Mocny, scientific leader-Early Development, both with Ab- zena; Peter Ercoli, chief operating officer, Biologics, at BIOVECTRA; Deepak Thassu, PhD, MBA, senior vice president, R&D and Regulatory Submission, at LGM Pharma; Emma Rhodes, head of New Product Intro- duction at Sterling Pharma Solutions; Sara Schemel, senior process engineer, Dona York, principal process engineer, and Gauri Patki, senior process engineer, all at Catalent Biologics; Uwe Hanenberg, PhD, head of Product Development at Recipharm; and Rebecca Powell, associate director, Tech Transfer at Arranta Bio, a Recipharm company. Considerations in tech transfer PharmTech: How does the tech transfer of complex products, such as mRNA vaccines, differ from tech transfer of legacy small-molecule products? Dieterich and Mocny (Abzena): A key difference between tech transfer of small molecules and com- plex products like mRNA tech transfer is familiarity. The methods and processes used for small-molecule manufacturing are generally well-understood and defined. [Whereas], the production of relatively new Communication is Key in Complex Tech Transfer Susan Haigney, managing editor The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

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