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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
July 03, 2023
Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.
July 02, 2023
Data from environmental monitoring can assist in keeping sterile environments sterile.
Automation can be balanced with operator oversight.
Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.
Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.
Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.
The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.
Problems continue despite actions by regulators to better prevent and address drug shortages.
FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.
If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.