Unlike traditional drug development, cell therapy logistics require extremely close, integrated relationships with contract research (CRO) and manufacturing (CDMO) organizations. Due to the direct line from patient to manufacturing and back, these partners function as critical extensions of the core team to ensure timeliness and safety.

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.

As the outsourcing market becomes crowded, technical capabilities are table stakes. For smaller biotech clients, the key differentiator is now customer service. Poor service experiences are creating lasting negative impressions, making relationship management critical for CDMOs to win business from this growing segment.

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 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.

The true constraint in scaling sterile fill manufacturing is the availability of skilled personnel, not the equipment. The expertise required for compliance and product launches is harder to acquire than capital assets. This makes proactive, long-term hiring and training a critical competitive advantage for growth.

The increasing volume of new therapies requires pharma companies to stop treating each launch as a unique event. Instead, they must develop a scalable, repeatable, and excellent launch capability to handle the future pipeline efficiently and consistently.

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.

To overcome production bottlenecks, Legend Biotech employs a diversified manufacturing strategy. They operate their own large facilities in the US and Belgium while also contracting with pharmaceutical giant Novartis to produce their CAR T therapy. This enables a rapid scale-up to a planned 10,000 annual doses.