Search results for " opportunity" in Articles / App Notes
Article
Single-use technologies in downstream process intensification
In bioprocessing, thorough cleaning is critical in order to take full benefit of the resin by removing impurities. When using conventional chromatography solutions, cleaning and cleaning validation …
Article
Managing Biomanufacturing Capacity Expectations
These developments can arise because an opportunity presents itself to improve a drug or add more indications—or, scientific issues may have to be addressed that were not planned. Wyss notes that ther…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Product development
New product development presents an ideal opportunity to incorporate all the relevant principles of SbD into the new process. Here, product safety is intentionally desi…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
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Antibody Fragments and Their Purification by Protein L Affinity Chromatography
Antibodies and related proteins comprise one of the largest and fastest-growing classes of protein pharmaceuticals. A majority of such molecules are monoclonal antibodies; however, many new entities…
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The Metrics of Quality Culture
The guidance leaves the opportunity open to establish quality-culture metrics by stating, “these metrics are not intended to be an all-inclusive set of the quality metrics that FDA could consider usef…
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Selecting a Comprehensive Bioburden Reduction Plan
In these cases, the hold times are typically shorter, but there is less of an opportunity to reduce the temperature of intermediate product pools. As such, the approach that might be adopted for biobu…
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Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
Article
Biopharma Advances Demand Specialized Expertise
Those companies that are best able to successfully characterize and differentiate innovator and biosimilar products for safety and efficacy will have the greatest opportunity to benefit.
The knowle…
Article
Re-use of Protein A Resin: Fouling and Economics
Overall, the survey suggested that there may be opportunity for manufacturers to come up with more economical Protein A resins with extended lifetime.
Summary
The survey provides a detailed in…