Search results for " biologics"
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
FDA Urged to Preserve Biosimilar Naming Conventions
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in the United States for chemical drugs and currently approved biologics, the…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Q&As with Industry Leaders
Discovering the unknown: How does in silico process development change PD scientists’ work?
Jeanne Linke Northrop, BioPharm International
Nora Ketterer, Manager, Modeling Services…
Article
Manufacturers Struggle with Breakthrough Drug Development
31, 2014, manufacturers submitted 140 requests for breakthrough status for drugs and biologics; the agency has approved 39 of these, approximately 30%, and denied 76. New approvals in 2013 included th…
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
Article
Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
Today, mAbs constitute the single largest class of biological drugs and accounts for about 36% of the total biologics market with an annual sales growth rate of approximately 10% (4).
Com…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
…s Schmid, and Michael Larson are development associates, all in the Process Development Group at CMC Biologics, http://www.cmcbio.com/.
REFERENCES
1. FDA, Draft Guidance for Industry: Targe…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
However, it was assessed and approved in the US as an original biologics license application (BLA), because a biosimilar pathway was not available to the sponsor at the time of submission to the regul…