Search results for " drug" in Articles / App Notes
Article
Biosimilars to Drive Modern Manufacturing Approaches
FDA officials are emphasizing how advanced analytical methods can document product performance similar to a reference drug, and that cutting-edge technology can ensure reliable production of high-qual…
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EMA Collaborates with HTA Assessment Networks
The licensing of a new drug is only a preliminary step in what can be a lengthy and complex procedure for some pharmaceutical companies, particularly those with innovative biopharmaceuticals. First a …
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change (SIC) …
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A Closer Look at Affinity Ligands
This concept is applied to the drug development sector and revolutionized manufacture of large complex medicines where use of ligands that have a specific affinity for the drug are used for purificati…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
…because of its promise and potential to increase efficiency and thereby reduce the cost of producing drugs and the time it takes to get them to market. Workflows, capital and operating expenses, prod…
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Best Practices for Selecting a Top-Quality Cell Line
Challener
Cell lines determine the performance of bioprocesses and the quality of the biologic drug substances they produce. As such, selection of the optimum cell line for each specifi…
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Moving PAT from Concept to Reality
Speeding drug development is crucial given that many drugs in clinical trials fail to reach the market. Drug companies would like to start manufacturing process development later in the overall develo…
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Advances in Engineering of Protein-Based APIs
Bi/multispecific and fusion proteins are emerging as promising third-generation protein drug substances. Peptides and peptidomimetic therapeutics offer the advantages of mAbs but in smaller molecules …
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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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