For small and medium-sized biotech’s, for many years the common practice has been to outsource to both contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) to help streamline processes and allow companies to focus on their pipeline.

However, there are some companies wavering and even more so given the recent announcement of the US Biosecure Act, first mentioned in December 2023. The Act proposes to prohibit federal contracts with biotechnology providers connected to foreign adversaries. Some Chinese companies in the drug manufacturing industry have been added to the list, and given this list is likely to grow further, companies are considering other options to keep their development in line with the Act.

While some will be trying to secure contracts with US CDMOs, some companies may be considering taking manufacturing processes in-house. This can be an effective way to manufacture, given the company full control and not being limited by time slots. It is however costly and requires a great deal of experience to be employed in the team.

Carol Houts, Chief Strategy Officer at Germfree, a cleanroom manufacturing company, speaks to the Clinical Trials Arena about the positives and negatives of bringing manufacturing in house and the key impacts that biotech’s should be considering.

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