BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.
Demand for biologic drug processing is placing pressure on contract manufacturing organizations to meet capacity demands in a timely manner. Christoph Winterhalter, senior vice-president of business development at Rentschler Biotechnologie GmbH, discusses the ways the company is prepared to handle new challenges related to client requests and heightened scrutiny from regulatory authorities.
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FDA Approves Pfizer Combination Regimen for Treating R/R Diffuse Large B-Cell Lymphoma
February 14th 2025The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.