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www.biopharminternational.com Manufacturing and Facilities 2022 eBook BioPharm International ® 35 OUTSOURCING its performance continuously evolving. As a drug de- veloper, these costs may seem elevated—especially if associated with no commitment to final yield—when presented with them for the first time by a contract ser- vice provider. But in many cases, these costs are similar to or lower than the developer would otherwise expe- rience doing everything in-house. When considering perceptions around control, it is often a point of frustration for product developers that issues arise at contract service providers that cre- ate problems for their programs. It is true that such setbacks can have a serious impact on the overall prod- uct development timeline and even the financial via- bility of the company. This may lead to the belief that CGT CMC activities are better performed in-house, as this enables more direct control and—as such—more reliable outcomes. This may not always be true. It is unlikely that qual- ity standards or reliability are significantly lower at CDMOs than for comparative internal performance. For larger pharmaceutical companies, whether in new product platforms or on more mature product classes, everything doesn't always work perfectly all the time. Sometimes, mistakes are made. It is important to con- sider how issues arising externally at CDMOs would be viewed if they occurred internally. As such, the bar may be set higher for a CDMO in relation to what would be accepted in-house. Deciding whether to outsource or insource Let's break this down and examine working with CDMOs from the perspective of a large organization as well as from the perspective of small biotech com- panies. For a large company with the financial means and a deep and promising product pipeline, it might make more sense to insource if a company has the financial capital to construct, buy, or reconvert the necessary facilities (manufacturing and testing) and recruit, train, and develop the different supporting teams. Depending on how companies with scale and financial means see their pipeline developing in the coming years, perhaps the "make" decision is the best one. But with all of this (facilities, trained personnel, etc.), large companies must be ready on time for their product pipeline and also consider their competitors' products (and their anticipated arrival to market). If the timing is not coherent with the product mile- stones, maybe a medium-term partnership with a contract service provider can be a prudent choice (a "hybrid" model). This could allow a company to con- tinue to develop a product internally in alignment with their chosen platform (manufacturing and ana- lytical) while supplying clinical material via a CDMO. CDMOs are generally quite f lexible in this regard and can adapt to different platforms. On the other end, many younger and/or smaller biotech companies may not have the relevant skill set or experience to guide their own CMC activities. In some cases, the team is focused on the direct prod- uct aspects (clinical evaluation, fundraising, etc.) and does not have the capacity or experience to develop and drive the CMC program. An experienced CMC professional can be brought on board to enable the company to develop the CMC program, but they may not have experience in all relevant areas. As such, working with a CDMO may be the prudent choice here. A key consideration for these companies may be man- ufacturing and analytical portability, as the company or its product assets may be acquired in the future by another company that already has internal CMC ca- pabilities or is working with a different preferred pro- vider, and the transfer to another provider should not be a blocking point for a potential deal (between the biotech company and the acquiring company). Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 1 BioPharm International's sister publication, Pharmaceutical Technology, presents the Drug Solutions podcast, where experts share insights into the technologies, strategies, and regulations related to the development and manufacture of drug products. In what instances should organizations outsource vs. insource? Determining the right outsourcing strategy is key to limit unnecessary costs, maintain output and turnaround times, and enable continued flexibility. In, "Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 1," John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals, shares outsourcing strategies in biopharma. Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 1 PharmTech.com/drug-solutions-podcast