Search results for " biologics"

Article 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…

Article 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, …

Article 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…

Article 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…

Article Mapping a Route for Cell and Gene Therapy Process Development
These products are highly complex and often involve production methods that, while in some ways are similar to those used in biologics and vaccine manufacturing, in many ways are quite different. …

Article Driving Improved Access to Biosimilars
US Federal Register, “Proposed Rule, Biologics License Applications and Master Files,” federalregister.gov, June 28, 2019.  

Article Methods Accelerate Biosimilar Analysis
…zation of primary structure and both enzymatic and non-enzymatic post translational modifications of biologics. Until recently, higher-order structures, including secondary and tertiary structures, w…

Article Making the Move to Continuous Chromatography
…ccording to Michelle Najera, senior development scientist for downstream product development for AGC Biologics. “The load phase can be split into two columns in series as well, allowing more product …

Article Industry Adoption of Single-Use Systems Remains Low
One of the company’s most important investments was the 2012 acquisition of Xcellerex, a supplier of manufacturing technologies, including FlexFactory for biologics, a centrally automated, flexible bi…

Article Reducing Cross-Contamination Risks in Process Chromatography
Preferred target molecules A variety of biologics benefit from the use of disposable technology in their production, from monoclonal antibodies (mAbs) and recombinant medicines to vaccines and…

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