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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
August 02, 2022
CRYOPDP is expanding its footprint to Spain with its acquisition of Polar Expres.
Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.
The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.
Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.
FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.
Promising applications for targeted delivery may be cresting the horizon.
Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.
Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.
FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.