Search results for " production"
Article
Mapping a Route for Cell and Gene Therapy Process Development
Challener
The regenerative medicine field is still quite young, and companies developing commercial processes for the production of cell and gene therapies face several hurdles. These product…
Article
Maximum Output Starts with Optimized Upstream Processing
Viral vectors are a special case
Viral vectors, which are used directly in therapeutics and vaccines and also in the production of gene and gene-modified cell therapies, represent a special case…
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Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
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Platform Approach Speeds Process Development
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
Commercial production of complex biopharmaceuticals such as recombinant monoclonal an…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Mammalian cells meet these criteria quite efficiently by virtue of their post-translation modification system, and this has made them a dominant production system for the biopharmaceutical industry. M…
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A Look Ahead at BioPharma Manufacturing and Regulation
FDA will consider establishing different frequencies for active ingredient and finished dosage form production facilities. Facilities that make sterile drugs will likely be a higher priority than othe…
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Understanding Validation and Technical Transfer, Part 3
Non-traditional process validation
The following example of production of cells used in autologous cellular immunotherapies for personalized medicine demonstrates how some conventional validation …
Article
Continuous Manufacturing: A Changing Processing Paradigm
It is expected to use fewer resources and increase bulk production capabilities, which is estimated to result in “a cost reduction of 60% or more per gram of protein,” according to an Amgen statement …
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Single-Use Technologies Prove Effective for Viral Vector Process Development
“The ability to provide a reproducible and uniform ideal microenvironment is a prerequisite for reproducible and uniform vector production in a bioreactor,” he states.
Increasingly, single-use tec…
Article
Aseptic Processing: Keeping it Safe
While investigational medicinal products are not typically expected to be validated at the same standards as are products for routine production, sterile products must have validated processes “of the…