BioPharm International - November 2022

BioPharm International - November 2022

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Page 32 of 36 Manufacturing and Facilities 2022 eBook BioPharm International ® 33 I n the past 20 years, the contract development and manufacturing organization (CDMO) sector has grown strongly—initially in chemical man- ufacturing (outsourcing capacity for special- ized manufacturing chemistries) and more recently for biopharmaceutical manufacturing, as parts of this sector have matured (e.g., monoclonal antibody therapeutics [mAbs]) (1). Choosing a CDMO When (or whether) to work with a CDMO for all or part of bioprocessing development needs, or whether to keep these activities in-house, has been the sub- ject of many articles, reviews, and discussions (2–9). These reviews, principally in the trade media, have dealt extensively with thematics such as scope, ex- pertise, capacity, quality systems, and risks when evaluating whether to develop and/or manufacture biotherapeutics in-house or outsource these activities to an external partner. Among many of these factors that could be con- sidered (2–9), this decision comes down to some key considerations (see also Figure 1): • Expertise. Determine whether the necessar y expertise/capabilities exist in-house. This can include at a minimum scientific and technolog- ical expertise but can also extend to associated expertise, such as the ability to translate the manufacturing and analytical technology into current good manufacturing practice (CGMP) mode, scale it up, or support regulatory activi- ties (e.g., dossier submission). • Capacity and technology. Is the analytical and manufacturing technolog y at the necessar y scale and standard to develop and/or produce the product at the required volumes? Is this capacity available now, or is it being built and will only come online in a couple of years' time? • Economics. Is the product pipeline sufficiently developed to utilize internal capacity (based on Choosing the Right CDMO for CGT Programs Brian Mullan is the chief technical officer of Yposkesi, an SK Pharmteco company. Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products. VITALII VODOL AZSKYI - STOCK.ADOBE.COM

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