Search results for " assays"
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
Being Thorough When Transferring Technology
Due to the complex nature of biologics and uncertainty of how the biochemical and in-vitro assays truly simulate the mode of action in vivo, exerting control on the manufacturing process is an integra…
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USP Publishes Monoclonal Antibody Guidelines
…assay (SEC) and the capillary sodium dodecyl sulfate (SDS) electrophoresis (reduced and non-reduced) assays (CE-SDS), described in General Chapter .
For SEC, the monoclonal IgG system suitability…
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Vaccine Development and Production Challenges Manufacturers
…rch and Development Authority (BARDA) in HHS is working with vaccine makers to validate and optimize assays. These would facilitate comparability studies for eventual licensure of the vaccines from G…
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High-Throughput Process Development in an Historical Environment
Instead, the main utilization of its high-throughput technologies and equipment are mainly used for sample preparations for complex assays, which has proven to be very beneficial.
Conversely, Vane…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
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Predicting Progress in Protein Aggregation
There are ongoing studies aimed at developing sophisticated cell-based assays for the evaluation of the immune response to protein aggregates, but despite some preliminary links between in vitro data …
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Comparability of the reference products of one original manufacturer but from different jurisdictions could be established by similarity of quality based on stringent analytical and biological assays,…
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QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…