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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.
A look into the latest developments in biopharmaceutical manufacturing and facilities.
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.
March 06, 2024
The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.
February 28, 2024
The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.
February 27, 2024
CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.
February 05, 2024
The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.
February 02, 2024
Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.