To ensure a robust tech transfer, biotech companies should first develop and optimize analytical assays internally. This establishes a deep understanding of product characteristics and process parameters before outsourcing, preventing downstream issues and ensuring the CDMO has a well-defined protocol to follow.
A key manufacturing advantage is using simple, non-pathogenic strains. This strategy sidesteps the need for expensive, high-containment facilities like BSL-2 or BSL-3 that are required for working with pathogens, resulting in a more cost-effective and lower-tech process that can even be run on a benchtop.
Early-stage biotechs must prioritize defining CQAs and developing quantitative assays from day one, even before it seems necessary. This includes creating tools like monoclonal antibodies to quantify the product. This early focus on what defines a 'good product' ensures experiments are designed to meet regulatory expectations from the outset.
Critical expertise doesn't always come from industry conferences or formal channels. The CEO of Versatope found a key CMC consultant at a Boy Scout event. This demonstrates the value of discussing your work in everyday settings, as crucial team members can be found in the most unexpected places.
Instead of over-engineering processes, lean biotech startups should focus on identifying the absolute minimum requirements for regulatory acceptance. This "good enough" mindset simplifies development, allowing teams to complete essential work first, meet deliverables, and conserve precious resources by filling in less critical details later.