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Despite a growing number of biosimilar approvals, market uptake remains a challenge.
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Proprietary cell lines offer opportunities for achieving high AAV titers.
A tidal wave of questions floats the need for more upstream automation.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
February 21, 2024
GSK is expanding its respiratory biologics portfolio with its acquisition of Aiolos Bio and its novel therapy, AIO-001.
February 20, 2024
Challenges in fermentation can be addressed through equipment changes, facility design, and process development.
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
February 16, 2024
In surplus and shortage, compounding amplifies all.
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.
February 15, 2024
An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.
The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.
February 12, 2024
Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.
February 09, 2024
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
February 08, 2024
Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.
February 07, 2024
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.