Search results for " biotechnology"
Article
Framing Biopharma Success in 2016
Senior executives of large biotechnology and pharmaceutical companies surveyed by ReedSmith (3) plan to stay on the investment track; 94% plan to initiate an acquisition during the next 12 months; mor…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Changes in OPQ’s Office of Biotechnology Products (OBP), for example, aim to enhance its capacity for assessing the quality and safety of a broader range of biotech therapies in development or under r…
Article
Drug Discovery and Development in India
According to a study into life-sciences venture capital published in 2013, only 32 out of a surveyed 170 biotechnology firms in India were backed by venture capital (2).
Market challenges
Phar…
Article
Continuous Manufacturing: A Changing Processing Paradigm
… Novartis AG are among the pharmaceutical companies and contract organizations building or expanding biotechnology facilities to make drugs in innovative ways. BioMarin and Vertex also plan to incorp…
Article
Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
Application of Quality by Design to Viral Safety
ICH Q5A, Note for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Animal Origin, describes how the level of viral contami…
Article
Challenges of Protein Aggregation During Purification
Careful selection of downstream processing conditions is a must.
Sep 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 27, Issue 9, pp. 32-35
Removal of protein a…
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…