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Growth and Advancements in Fill/Finish
Employing novel technologies and more patient-centric approaches
Delving into Biopharmaceutical Development and Manufacturing
Quality Considerations in Changing Excipient Providers
May 08, 2024
This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
May 07, 2024
Novel delivery technologies enhance brain penetration to target neurodegenerative diseases and glioblastomas.
ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.
The two companies will combine their cell therapy platforms to develop convertibleCAR programs targeting solid tumors.
May 06, 2024
The request for more information was received weeks after an application to the FTC was refiled to approve the deal.
Digital transformation is allowing for better handling, analysis, and protection of vast data collection.
The use of appropriate taste-masking and appearance technologies can facilitate patient compliance.
May 05, 2024
A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.
May 04, 2024
The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.
A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.