By Christian Cattaruzza, Steven Strubbe, Laure Valognes, Corinne Lavie-Cambot, Laetitia Botrel, and Muriel Richard, BioReliance® End-to-End Solution
Selection and implementation of a commercial manufacturing strategy that will ensure long term success is among the most critical decisions a biopharmaceutical company will make.
Every drug is unique and there are many options and factors to consider when it comes to identifying the best approach to commercial GMP manufacturing. The right strategy must align with your organizational objectives and be cost-effective, deliver the necessary quantity of drug substance, reduce risk and meet regulatory expectations. In this guidebook, our experts share key considerations for biopharmaceutical companies as they advance to commercial manufacturing and navigate complexities associated with business planning, process scale-up, optimization and validation, technology considerations and regulatory compliance.