BioPharm International - May 2023

BioPharm International May 2023

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32 BioPharm International ® Partnerships for Outsourcing eBook May 2023 www.biopharminternational.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 another. Complex products such as biologics and messenger RNA (mRNA) vaccines come with addi- tional challenges during the tech transfer process. To gain more insight on the complexities of trans- fer of pharmaceutical technology between contractors and sponsors, BioPharm International ® spoke with Petra Dieterich, scientific leader, and Jeffrey Mocny, scien- tific leader-Early Development, both with Abzena; Peter Ercoli, chief operating of f icer, 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 BioPharm: How does the tech transfer of complex prod- ucts, 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 technologies like mRNA tech and other complex new biologics can present unique challenges some devel- opers and manufacturers haven't experienced before, particularly as the project scales. 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. TADAMICHI - STOCK.ADOBE.COM

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