Search results for "biologic"
Article
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…
Article
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…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
…shbone 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-assessment…
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
But she notes that is not always true for biopharmaceuticals, for which biological activity is in the third dimension. “With biopharmaceuticals, a great deal depends on how the individual molecule is …
Article
Methods Accelerate Biosimilar Analysis
…ation of primary structure and both enzymatic and non-enzymatic post translational modifications of biologics. Until recently, higher-order structures, including secondary and tertiary structures, we…
Article
Making the Move to Continuous Chromatography
…cording 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 t…
Article
Industry Adoption of Single-Use Systems Remains Low
The ability to manufacture a comparable amount of biologic product due to process optimization means a smaller facility with single-use equipment can be a preferable solution to a traditional stainles…
Article
Reducing Cross-Contamination Risks in Process Chromatography
Today, single-use bioreactors are widely used for biologic drug manufacturing, and downstream disposable technologies for commercial-scale production operations are being introduced and increasingly a…