By Nina Weis, Julia Doreen Johann, and Tim Berger
Affinity and ion exchange resins are essential to the purification of monoclonal antibodies, vaccines, plasma and novel therapeutic modalities. Because of their fundamental role in manufacturing processes and the impact on drug product purity and yield, assurance of quality and supply is vital to avoid shortages which could ultimately affect patient care. Any changes in the quality of the resin can impact the impurity profile, such as the content of host cell proteins and DNA, which in turn, could affect the quality and efficacy of the medicine. Adding to the need for quality and supply chain control is the fact that chromatography resins are often sourced from a single supplier as qualification processes for new manufacturing processes are costly and time-consuming, as is replacing a resin in an existing manufacturing process.
This white paper explores key components of our chromatography resin supply chain program which help customers control their supply chains as they seek to ensure steady progress towards their next milestone and consistent availability of medicines for patients in need.