13 Keys to a Successful Monoclonal Antibody BLA Submission
By Modality SolutionsWhen a monoclonal antibody therapy advances through its development lifecycle, planning ahead and optimising the biopharmaceutical cold chain is key to advancing towards approval.
Monoclonal antibody treatments have specific requirements for shipping validation and require a more precise and thorough regulatory submission process—which starts with a biologics license application (BLA) filing.
In this guide, we’ll go over what you need to know to ensure your cold chain is ready for a successful filing.