Search results for " pharmaceutical"
Article
Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
Resource
Interphex
April 17-19: INTERPHEX is pharmaceutical, biotechnology, and medical device development and manufacturing event where you can “Experience Science through Commercialization”.
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
In a draft guidance for industry, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (December 2015), the agency outlined a process for biopharmaceutica…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
There is also a growing interest in the pharmaceutical industry to develop small-scale models to study the potential impact of large-scale freeze-thaw process variables on protein stability. The small…
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Biosimilars to Drive Modern Manufacturing Approaches
Momenta Pharmaceuticals CEO Craig Wheeler agreed that advances in biotechnology manufacturing and efficient plant utilization will be key over the long term for biosimilars to provide an expected 30-4…
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
Article
Analysis of Glycosylation in Biosimilars
In summary, glycosylation is a post-translational modification present on many proteins of pharmaceutical significance, and as such must be characterized and monitored closely. MS analysis provides de…
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Microbiological Testing: Time is of the Essence
Conventional protocols no longer suitable for traditional biologics
Microbiology testing of pharmaceutical products is performed with a view to detection, enumeration, and identification of microbi…
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Continuous Processing for the Production of Biopharmaceuticals
An example of this is the MIT-Novartis collaboration in continuous pharmaceutical production. In recent years, there have been publications reporting development of a fully integrated end-to-end comme…