Search results for " formulation" in Articles / App Notes
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…
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).
Article
Breakthrough Drugs Raise Development and Production Challenges
For biologics, breakthrough designation may prompt greater focus on the reliability of the Phase I cell line, process and formulation, as shorter pivotal trials may truncate optimization of the Phase …
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Have the end in mind
Such things as formulation issues, dosage potency, impurities, residuals, and microbial assurance need to be thought out clearly from the start, Hampson says, as well as indic…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
Fuller adds that the immunogenicity risks associated with biosimilars could relate to their formulation and technology platforms, “but the specific patents will not be known, as the originator will no…