Manufacturing And cGMP For Cell And Gene Therapies

Practical considerations for establishing GMP manufacturing of cell and gene therapies

Ultimately, two objectives exist for the commercial manufacture of advanced therapy medicinal products (ATMP) and cell and gene therapies (CGT). The first is to deliver an advanced therapeutic benefit to patients, and the second is to capture a return on investment for the manufacturer. Achieving both objectives depends critically on the manufacturing decisions taken throughout the therapy development process.

Advocating a complete consideration of the manufacturing pathway for early stage therapies is naïve. In reality, therapeutic development is a game of resource allocation and risk management. Balancing the combined risks of a non-linear therapy development pathway, funding limitations, clinical trial progress and scarcity of skilled personnel means giving the right amount of attention to commercial manufacturing considerations. Too little attention, paid too late, risks embedding schedule or cost burdens. Conversely, expending too much effort too early could distract from the core therapy development – a pitfall that could conceivably kill the company. How then, can therapy owners appropriately consider manufacturing establishment as they progress their development towards commercialization?