Know Your Product, Know Your Path: A Primer On Advanced Therapy Development
By Michael Covington and Gregg Nyberg, Landmark Bio

Small biopharma and academia — often credited with being the primary drivers of innovation — sometimes lack the specialized expertise and resources necessary to develop robust manufacturing processes. Immature manufacturing processes can result in variable product quality and, eventually, to delays in regulatory approval.
Through a deeper understanding of a product’s critical quality attributes (CQAs) and the critical process parameters (CPPs) that influence them, manufacturers can prevent knowledge gaps and design a process and control strategy that ensures a product will consistently meet today’s rigorous quality standards.
Moreover, when developing advanced therapies, it is vital to devise regulatory and CMC strategies early and in alignment with one another. Otherwise, the sponsor potentially risks significant process changes becoming necessary in the midst of a pivotal clinical trial. Focusing on near-term milestones and objectives, without full consideration and understanding of actions that drive commercial success, can slowly undermine an advanced therapy development program. To that end, helping customers thoughtfully define their products and create bespoke CMC roadmaps is part of Landmark Bio’s expertise.
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