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There are considerations companies may want to consider before seeking out a service provider.
Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.
Demand for efficient tech transfer, as well as compliant on-time delivery, is rising.
April 23, 2024
As the industry adjusts to new regulations, including Annex 1, bio/pharma manufacturers must rethink facility designs to remain in compliance.
April 22, 2024
BioPharm International sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies at INTERPHEX 2024 to examine the implementation of Annex 1.
April 04, 2024
Lonza has made a deal with Acumen Pharmaceuticals to manufacture sabirnetug, a mAb that will soon be entering Phase II development for treating Alzheimer’s disease.
April 01, 2024
A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.
March 28, 2024
The new Verafit products from STERIS are designed to help manufacturers conform to regulatory requirements laid out in Annex 1.
March 21, 2024
CDMO White Raven aims to reduce contamination risk and gain the capability to handle multiple product formats with the installation of Cytiva’s SA25 Aseptic Filling Workcell.
March 19, 2024
Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) marks the first gene therapy approved in the US for treating children with metachromatic leukodystrophy.
March 13, 2024
Under a new agreement, Chime Biologics will manufacture Domain Therapeutics’ antibody cancer immunotherapy candidate, DT-7012.
The company is investing more than $2 million in its analytical testing services and adding suppository manufacturing capabilities.