Search results for " formulation"
Article
Drug Quality Key to Innovation and Access
And pressure to combat the devastating opioid epidemic across the United States highlights the need for innovative methods to produce new formulations to treat pain that also resist abuse and misuse. …
Article
Microbiological Testing: Time is of the Essence
Due to the recent discovery of this phenomenon and the various formulations of drug substances and drug products, there have been difficulties in developing proper studies for LER.
Rapid solutions:…
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Make buffer preparation more time and cost efficient with inline conditioning
Both standard formulations and customized solutions are available.
To learn more about how buffer preparation can be made simpler, and other ways to gain efficiency in downstream bioprocesses, dow…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Demand for custom formulations and packaging have increased, as has customer demand for quality control reports.
Several suppliers reported facility expansions to increase capacity for these vital…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Framing Biopharma Success in 2016
…e made in the boardrooms of bio/pharma companies, but the frontline professionals--those involved in formulation, development, and manufacturing functions--can offer interesting observations about th…
Poster
Benchmarking, scalability, and protein production in CHO cell culture
ActiPro cell culture medium and feed supplements has a tailored formulation that supports viable cell counts of more than 25 million cells per mL and protein production greater than 5 grams per liter…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
…s in the 20–200 mg range, and covers the requirements for early in vitro and in vivo profiling and formulation of these drug candidates.
Read the full article.
Article
Best Practices in Qualification of Single-Use Systems
Hershenson, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals (Wiley, 2010).
15. L. Ducry, Antibody-Drug Conjugates (Humana Press, 2013).