ARTICLES BY BRIAN CLARK
-
Complex Antibody-Drug Conjugate Supply Chains: To Integrate or Not?5/29/2018
The number of critical components in the antibody-drug conjugate (ADC) production process creates one of the most complex supply challenges in the biopharmaceutical industry. The decision to go with one or more CDMOs is the start of a partnership that will be key to the success of an ADC product.
-
Beyond The FDA Guidance: Practical Considerations For Quality Agreements5/19/2017
Many sponsors, particularly small to midsize organizations, opt to use their CMO’s boilerplate quality agreement. These agreements in many cases are compliant with the standards, but they usually lack many of the practical details to ensure an effective relationship with clear expectations.
This website uses cookies to ensure you get the best experience on our website. Learn more