Search results for "raw material variability"

Article The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…

Article Raw Material Variability
Raw material variability may lead to quality compliance issues, process inconsistency, or bioprocess productivity problems. Many of these issues would be upstream in the cell-culture or fermentation s…

Article The Evolution of Supply Chain Security: Increasing Focus on Raw Material Variability
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened raw material control. Click here to read more >>

Article Managing Risk in Raw Material Sourcing
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial. By Agnes Shanley Choosing excipients and supplie…

Article Raw Material Variability: The Need for Deeper Process Understanding
This article shares some insights into how raw material variability is a potential source for process variation. The focus lies on chromatography resins. Click here to read more.

Article Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment. Click here to read more >>

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance. Oct 1, 2014 BioPharm International …

Article Economic drivers and trade-offs in antibody purification processes
The future of therapeutic MAbs lies in the development of economically feasible downstream processes.  By Suzanne S. Farid, PhD  ABSTRACT Increasing titers in mammalian cell culture has rec…

Article Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain. Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…

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