Search results for " method"
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Part of this initiative identifies specific standards, methods, and questions for drug reviewers to use in their review process. The overall effort builds upon the agency's Critical Path Initiative, l…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Scale-up/scale-out:Stability studies and cryopreservation/biopreservation methods optimization, logistics worked out.
Manufacturing change validation/product comparability studies:Necessary t…
Article
Preclinical Evaluation of Product Related Impurities and Variants
First, a rigorous method for separation of these variants is needed (23) and is non-trivial due to the fact that the physicochemical properties of these variants are nearly identical. Researchers have…
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Ensuring the Biological Integrity of Raw Materials
These procedures are effective for most agents, but some organisms, particularly viruses and prions, have evaded standard prevention and testing methods. New technologies in biosafety testing target t…
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Sterilization Trends for Single-Use Consumables
“As EtO and gamma irradiation, the principal methods used today, have a limited supply capacity, concerns persist that regulation changes, newsworthy events, and supply-chain constraints could easily …
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
…r of technologies that human operators must manipulate by automating sample collection, preparation, method implementation, and results analysis (inline or online), enabling automated and continuous …
Article
Reimagining Affordable Biosimilars
Recent advancements in technology and computational biology offer tools for development of accurate and predictive methods to understand the potential risks related to safety and efficacy. With the ev…
Article
Good Manufacturing Practices: Challenges with Compliance
With a single entity like a small molecule, characterization is straightforward, and we can utilize methods such as impurity profiling to give an accurate quality overview. However, complicated biolog…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
The method makes use of the mass transport limitation, which occurs when high-density ligand surfaces are used. By injecting the analyte at two different flow rates (e.g., 10–90 µl min-1), the active …
Article
Nurturing Knowledge from Disparate Data Streams
Pharmaceutical methods applied today generate increasing quantities of data. These data are stored and manipulated using a variety of software platforms from different suppliers. Pharmaceutical scient…