With the November 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the four key takeaways as well as your next steps for DSCSA compliance.
Allan Shaw offers a no-holds-barred retrospective on the top stories and trends of 2021. From the frontlines of the COVID-19 pandemic to the questionable approval of Aduhelm to leadership instability at the FDA and more, Shaw dissects the year past and predicts how those stories will influence the biotech industry in 2022 and beyond.
By L. Helmonds and P. Andrea, MWA Consulting, Inc. (a subsidiary of Mastercontrol)
A discussion on implementation of a phase-appropriate quality management system (QMS), the importance of starting early in the product development life cycle, and the advantages of a digital QMS over a manual approach.
This technical poster discusses how an alkali stable protein A resin is used as a platform for fragment monoclonal antibody (mAb) purification to overcome downstream challenges associated with nonclassical antibody constructs.