Search results for " biologics" in Articles / App Notes
Article
Witnessing Major Growth in Next-Generation Antibodies
…most prevalent technologies, according to Mike Riley, vice-president and general manager at Catalent Biologics.
The various formats can be placed into four main categories. One involves technolog…
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Managing Biomanufacturing Capacity Expectations
These findings could have implications for future demand calculations for biologics, as well as biosimilars with numerous market competitors—especially if the Centers for Medicare and Medicaid Service…
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Innovative Therapies Require Modern Manufacturing Systems
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and agency officials expect this pace to continue. Manufacturers are testing a full pipeline of importa…
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mAbs to Watch in 2016
Clinical-trial supplies of ibalizumab were manufactured at WuXi's biologics manufacturing facilities in China for its partner, developer TaiMed Biologics, according to a WuXi press release. The drug r…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
Even though one of the key objectives of the Biologics Price Competition and Innovation Act (BPCIA) is to identify and limit the number of patents that can be the subject of litigation, according to E…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
The very nature of aggregation is challenging, says St John Skilton, senior global market manager of biologics at SCIEX, a life-science analytical technologies company. The fact that aggregation is “d…
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Quality by Design and Extractable and Leachable Testing
Table I and Table II from FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics (4) illustrate this relationship.
USP and (3) are baseline tests that shoul…
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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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Eliminating Residual Impurities Starts with a Strategic Plan
…ishbone diagrams or failure mode and effects analysis (FMEA), agrees Luc-Alain Savoy, global head of biologics at SGS.
“Critical quality attributes will be identified during this risk-assessmen…
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Flexible Facilities for Viral Vector Manufacturing
Modular approach
Modular facility designs and modular construction are being used in biologics manufacturing, with a key benefit being faster time from inception to startup. The BioPhorum Group ho…