Search results for " GMP"
Article
Single-use Bioreactors Have Reached the Big Time
She does note, however, that the state of single-use sensor technology for use with single-use bioreactors in GMP biomanufacturing is constantly improving. “There are several approved biologic manufac…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
…ment purposes (pre-clinical), clinical trials, or commercial scale, as this will define the relevant GMP requirements. Also, if producing at commercial scale, which regulatory standard is needed? Is …
Article
Platform Approach Speeds Process Development
After an additional six months, material from GMP facilities can be provided for clinical studies resulting in a time requirement of 20 months from DNA to Investigational Medicinal Product Dossier. Th…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
At present, there is little or no standardized training on cell-culture best practices and authentication in basic biological research groups, although these do exist in GLP and GMP labs.
Im…
Article
Selecting a Comprehensive Bioburden Reduction Plan
In my experience, this is typically covered in GMP training, for example, gowning procedures, good aseptic practices, and specific operating procedures for operations, such as taking samples.
Mitt…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Some of the reasons leading to supply shortages could be increased market demand, poor product quality and/or GMP practice, increasing regulatory expectations, or limited or competing manufacturing ca…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
Article
Continuous Manufacturing: A Changing Processing Paradigm
There are also some worries about the overall novelty of the technology in the continuous space, as not all equipment needed to perform continuous processes may yet be available for GMP manufacturing.…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
To further reduce the risk of aggregates, FDA also recommends selection of an appropriate cell substrate, a facility that employs GMPs, a robust purification protocol, and formulation/container closur…