For novel technologies like photobioreactors, infrastructure is scarce. Companies must partner with separate CMOs for upstream cultivation and downstream processing to reach initial commercial revenue before building their own integrated facilities.

Infinimmune selected KBI Biopharma as its manufacturing partner partly because KBI's Celexis cell line is highly portable. This foresight de-risks future global scale-up, ensuring the manufacturing process can be easily transferred to different facilities worldwide, a key consideration for long-term commercialization and partnerships.

Contrary to the decade-long trend of outsourcing to CDMOs, major pharmaceutical companies are now vertically re-integrating their supply chains. Driven by supply chain vulnerabilities, they now view manufacturing not as a cost center but as a strategic advantage, creating opportunities for technology enablers rather than just capacity providers.

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.

The build vs. outsource decision is strategic. Building in-house is justified when manufacturing is a core competitive advantage or the process itself is your key IP. Otherwise, outsourcing to a CDMO offers critical speed to clinic and preserves capital.

A simple heuristic for the build-vs-partner decision: Does your manufacturing process create unique intellectual property? If so, own it. If it merely consumes capital, partner with a CDMO. This preserves precious resources for R&D, clinical evidence, and commercialization.

AdvanCell CEO Philina Lee, a veteran of multiple billion-dollar acquisitions, observes that successful radiopharma M&A targets like Algetta and Fusion shared a key trait: they owned their manufacturing. This vertical integration provides a crucial differentiator and de-risks the asset for potential buyers.

Eupraxia views its delivery technology as a broad platform beyond one drug. It employs a dual strategy: advancing its own pipeline of proprietary drugs in-house while simultaneously seeking external partnerships for other applications, like cancer therapy. This hybrid model diversifies opportunities and aims to maximize the technology's value across multiple therapeutic areas.

Instead of building costly in-house GMP capabilities early on, a more effective strategy is to concentrate on the core preclinical science. By partnering with established CDMOs and consultants for the translation to GMP, startups can de-risk development and accelerate their timeline to an IND filing.