Search results for " development" in Articles / App Notes
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Cell detachment is probably one of the most relevant processes hindering a faster development for cell-based biotechnology. In this article, the authors focus on different strategies available for ani…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
These developments have been timely, as regulatory authorities’ requirement for better understanding of product and process has encouraged a process-space approach to bioprocess development.
Chara…
Article
The Bullish Outlook for Biosimilars
This growth trend is set to continue, with more than 370 biologics currently in development, and pharma giants like AstraZeneca, Bristol-Myers Squibb, and Pfizer poised to have biologics represent a s…
Article
Improving PAT for Biologics
… is, however, a key enabler of PAT approaches, according to Kumar Dhanasekharan, director of process development at Cook Pharmica. Advances in high-throughput systems, Raman and near-infrared (NIR) s…
Article
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
Article
Evaluating Design Margin, Edge of Failure and Process
In this respect, limits are justified based on critical information gained from the entire process spanning the period from early development through commercial scale production.”
Table I: Measu…
Article
Global Expansion Shapes Drug Oversight
At a London meeting in April, senior leadership from FDA, EMA, and the European Commission reviewed efforts to leverage each other’s inspection resources; collaboration to support global development o…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Nonetheless, the pharmaceutical industry has been internally adopting the QbD concepts laid down in the guidelines of the International Conference on Harmonization (ICH) covering pharmaceutical develo…
Article
Drugs, At What Cost?
The underlying question for any drug in development is: What price can (or will) patients pay for the needed therapy? Patient sticker shock, government austerity programs, blockbuster drugs falling of…
Article
Best Practices in Adopting Single-Use Systems
Decisions made early in process development and scaleup will affect the trajectory of manufacturing at successive production scales. Employing best practices when selecting single-use products during …