Search results for " biologic" 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
This demand underestimation is an important finding considering the large number of biologic, immune-oncology therapeutics (with various proposed indications) that are currently in the pipeline. The a…
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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
Reslizumab—Teva is gunning for FDA approval in 2016 for its biologic reslizumab (trade name Cinquil), which targets IL-5. Although the company will first seek an approval for the medication for the tr…
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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
CQA is defined as a physical, biological, or microbiological property or characteristic that should be within an acceptable range to ensure the desired product quality. The FDA guideline states that C…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
A critical quality attribute (CQA) has been defined as “a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distributi…
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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…