Unlike small-molecule drugs, biologics manufacturing cannot be simply scaled up on demand because "the process is the product." A superior manufacturing and supply chain capability is not a back-office function but a key market differentiator that commercial teams must leverage to win customers and outpace competitors.

A Complete Response Letter (CRL) from the FDA due to manufacturing issues can destroy a biotech. CEO Ron Cooper warns leaders to invest heavily in Chemistry, Manufacturing, and Controls (CMC) early, even when the cost exceeds the clinical trial spend. This early investment in professionalizing CMC is critical to de-risk the company's future.

A capacity crunch in the US sterile fill market is driven by two factors: large pharmaceutical companies acquiring CDMO facilities for their own use, and a growing client demand for US-based manufacturing (reshoring). This creates a significant shortage and an opportunity for independent CDMOs with available capacity.

The sterile fill market isn't monolithic; it's segmented by manufacturing type. High-volume, low-mix products like GLP-1s require different CDMO capabilities than high-mix, lower-volume biologics. The latter demands deep expertise in tech transfer and new product launches, a distinct skill set from routine, high-scale production.

When founders claim a proven but labor-intensive channel 'doesn't scale,' they often misdiagnose a resourcing problem. The bottleneck isn't the channel's viability but their inability to solve the operational challenge of hiring, training, and managing a team to execute that channel at massive volume.

When preparing to scale a manufacturing team, the highest priority is the well-being of the core, foundational members. They hold the critical tribal knowledge and culture. Losing them to burnout right before a major expansion can cripple the entire operation.

The CDMO market is segmenting, rewarding companies that specialize in complex niches like sterile filling. Rather than trying to do everything, focusing on being a world-class expert attracts clients who need specialized services, much like a patient chooses a heart surgeon over a general pharmacy for a critical procedure.

Because in vitro gametogenesis is so new, there's no pre-existing talent pool. Ovelle's hiring strategy prioritizes finding intelligent scientists who can learn quickly. Scientific co-founder Merrick Smela emphasizes that his ability to train these new hires is a critical contribution to the company's success.

Unlike most biotechs that start with researchers, CRISPR prioritized hiring manufacturing and process development experts early. This 'backwards' approach was crucial for solving the challenge of scaling cell editing from lab to GMP, which they identified as a primary risk.