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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
November 10, 2022
The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.
November 09, 2022
The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.
The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.
November 08, 2022
The collaboration will see Shimadzu and UMG develop new clinical laboratory methods using LC-MS for TDM analysis.
MGI and Imperial College will jointly operate a CEC designed to provide European customers with first-hand experience with various automation and sequencing instruments.
Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.
November 04, 2022
This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.
November 03, 2022
Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality.
Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.
High-concentration injectable formulations present unique challenges.