Selection and implementation of a commercial manufacturing strategy is among the most critical decisions a biopharmaceutical company will make. Once the decision to outsource commercial production is made, it is essential to select the right partner. An experienced CDMO will be able to help you address important considerations when it comes to identifying the best approach for your commercial 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 their antibody drug to commercial manufacturing and navigate complexities associated with business planning, process scale-up, optimization and validation, technology considerations and regulatory compliance.

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