Search results for " GMP" in Articles / App Notes
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…
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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…
Article
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…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
At its simplest, the answer requires a comparison of the tasks, labor time, labor rate, raw materials, and overhead to pack a glass column on site and prepare it for use in a GMP suite with a similar …
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
… for one candidate, including the necessary mammalian cell culture facility built in compliance with GMP regulations and a highly educated and experienced workforce, according to Kim. “Since 2002, we…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Common quality assessors and GMP inspectors, however, usually do not have such knowledge, the study noted.
Design space verification
Both regulators and industry executives at the meeting conced…