Search results for " method"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…single-cell cloning of the candidate production cell lines using single-cell sorting (or alternative methods); and profiling of transgene copy number in cell-line populations across cell generations …
Article
Ensuring the Quality of Biologicals
monographs are supported by a large number of general chapters that describe standard methods. These general chapters give requirements for equipment and equipment verification and instructions on how…
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Predicting Progress in Protein Aggregation
…blishment of predictive models and more advanced analytical techniques, particularly high-throughput methods, to enable the design and formulation of stable, protein-based therapeutics.
T…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical manufacturers’ change-control systems are designed to ensure that any changes to raw materials, product contact materials, manufacturing methods, product tests, and production equipment…
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Regulatory Challenges in the QbD Paradigm
There is even the possibility of real-time release through the implementation of alternate and rapid microbiological methods and through the use of an effective microbial control strategy. A QbD inspe…
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Enhancing Resins Addresses Purification Concerns
However, for truly large target molecules or challenging feed streams, other purification methods may offer more competitive solutions,” Ihre explains.
“Another challenge in purifying pDNA i…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
The shutdown of many clinical sites and difficulties in visiting medical facilities required researchers to use virtual and remote methods for identifying potential trial participants, obtaining infor…
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Moving PAT from Concept to Reality
One of the greatest difficulties with many current at-line methods is the extended length of time required to receive results—for instance, 28 days for most cell-based assays. The focus of research in…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
In this method, a series of parallel exoglycosidase digestions is performed with enzymes that are specific for particular sugars that comprise N-glycans. Typically, the parallel reactions are individu…
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Being Thorough When Transferring Technology
During tech transfer, methods, skills, technologies, and importantly, knowledge is transferred from the drug developer to another site or group, often a contract manufacturing organization (CMO). It’s…