Harp talks ADCs on Exceeding Your Benchmark podcast
Feb 2, 2023
Innovation in the pharmaceutical industry results in manufacturing facilities having to pivot. This includes the change in drug delivery from chemically combining highly potent APIs and monoclonal antibodies into antibody drug conjugates (ADCs).
CRB’s Ashley Harp discusses a few of the challenges that come with such advancements in the industry. Finding a balance between containment and cleaning, lack of adequate manufacturing capacity, and a lag in regulatory guidance are a few of the areas that Harp addresses. She goes on to discuss a solution that includes a hybrid approach to manufacturing.
Overall, companies must plan for flexibility when planning and designing for new manufacturing facilities. By planning for flexibility, companies can save time and money, while also ensuring that they remain agile and compliant with GMP.