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.

Teams hyper-focus on replicating process parameters during tech transfer, but this is a blind spot. The true measure of success is a statistically powerful analytical and sampling plan that rigorously proves the process transferred successfully and can detect any deviations.

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.

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.

Companies, especially in early stages, should resist outsourcing production too quickly. Keeping a new process in-house is essential for understanding its pain points, which is a prerequisite for being able to specify clear, effective requirements to an external vendor later on.

To leverage modern, faster FDA pathways for biosimilars, robust analytical data demonstrating biosimilarity is critical. Therefore, a startup's choice of a Contract Development and Manufacturing Organization (CDMO) should hinge on their analytical expertise, which can reduce or eliminate the need for lengthy clinical trials.

Companies often mistakenly expect their CDMO to fill strategic gaps. A CDMO's role is to execute the plan provided. Handing over an incomplete process is a 'wish,' not a tech transfer, and forces them to improvise in ways that may not align with your regulatory or commercial goals.

In bioprocessing, it is more efficient to design a development process that accommodates the constraints of the manufacturing facility. Forcing a plant to adapt to a rigid process is difficult and costly. This includes making early, scalable choices about materials like chromatography resins to ensure a smooth tech transfer.