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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
February 21, 2023
In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.
February 17, 2023
In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.
The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.
February 16, 2023
To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.
February 15, 2023
Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.
Takeda’s acquisition of Nimbus Lakshmi will grant them rights to NDI-034858, an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases.
Bill Anderson, former CEO of Roche’s pharmaceutical division, will take over as CEO of Bayer on June 1, 2023.
GenScript PrioBio and Bio Immunitas will work together to develop and fast track manufacturing of a novel therapeutic platform.
The kit is meant for use for the detection and quantitation of residual host cell protein.