Search results for " pharmaceutical" in Articles / App Notes
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…
Article
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…
Article
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…
Article
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…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…mpurities (PRI), as defined by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q6B (8), and could have potential implications on the safety a…
Article
Going Small to Achieve Success on the Commercial Scale
“This approach to scale-down modeling is in the earliest phases and largely limited to large pharmaceutical companies and university research groups with the resources and computing power required,” J…
Article
Biopharma in 2015: A Year for Approvals and Innovations
First Hospira Biosimilar mAb Approved in West Europe, Randi Hernandez, Pharmaceutical Technology, Feb. 17, 2015.
3. Global & USA BioSimilar Market Analysis Report 2015-2021, Research and Markets, h…
Article
mAbs to Watch in 2016
Although the pharmaceutical manufacturers developing these mAbs will likely seek various indications for their products, the preliminary indications include treatments for various cancers, multiple sc…