Search results for " methods"
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…
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Preclinical Evaluation of Product Related Impurities and Variants
Although separation of basic variants has been achieved to a satisfactory extent, resolving acidic variants using either of these methods is partial at best. Second, isolating individual variants in a…
Article
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
One consequence of this emphasis on speed is increased demand for more efficient development and validation of faster analytical methods. Rapid inline or online methods that can provide results within…
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
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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…