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| Four Steps To Identifying The CDMO Proposal Worth Signing | Transparency and communication are essential to the success of a manufacturing partnership. If a CDMO is unwilling to have frank conversations during the proposal phase, that's likely a red flag. The right partner's team will help you make educated choices while ensuring quality, reasonable costs, and timeline efficiency. |
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By G. Gellermann, et. al., Novartis Technical R&D | Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP. |
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By Allison Radwick, U.S. Pharmacopeia | From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality. |
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By Maria Löflund, Takeda Manufacturing Austria AG | At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights. |
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| Quantitation Of Monoclonal Antibodies In Serum | White Paper | By Beata Talar, Ph.D., Mabion | Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development. |
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