Search results for " drug"
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Modeling the Degradation of mAb Therapeutics
FDA has approved a number of these antibody drug molecules, which are in various stages of clinical and pre-clinical development. But since the major constituent of the final drug product is protein, …
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Understanding Validation and Technical Transfer, Part 3
When correctly done, linking process to product to patient, validation ensures safe and effective drug and biologic products and benefits the patients whose health and wellbeing depend on them.
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Industry Adoption of Single-Use Systems Remains Low
The movement away from the blockbuster drug model to more targeted therapeutics, however, is driving the need for drug manufacturers to avoid costly investments in traditionally large, stainless steel…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
In support of a visual inspection program of the items being washed in the parts washer, a visible residue limit (VRL) study was performed on the final drug product as well as on a formulated alkaline…
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Platform Technologies Improve Protein Expression
Manufacturers are seeking mechanisms for increasing efficiencies and reducing costs without compromising the safety and efficacy of their drug products. In addition to exploring novel production metho…
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Patenting Prospects for Cell-Based Therapies
…es may not be given the type of robust patent protection conventionally available for small-molecule drugs. Even method-of-treatment claims, which are less prone to impediments in patent procurement …
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Unifying Continuous Biomanufacturing Operations
These products include drugs made by Baxter, Genzyme/Sanofi, Biogen, Merck Serono, Bayer, BioMarin, Pfizer, Janssen, Novartis, Shire, and Eli Lilly. Although these drugs only exploit continuous techni…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical industry by attacking disease using the mechanisms of the cell and immune system. These therapies are fragile…
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Defining Risk Assessment of Aseptic Processes
Schniepp
Q: I work in the quality group for a manufacturer who makes intravenous (IV) injectable drugs using aseptic processing techniques. Recently, the facility has experienced an increase in the…
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Perfusion in the 21st Century
Many drugs have or will soon come off patent, increasing pressure on manufacturers to reduce costs. The biosimilars market is growing at a healthy rate (5), yet it is also extremely competitive.
M…