Search results for " biotechnology" in Articles / App Notes
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…
Article
Trends in Downstream Bioprocessing
Indeed, a survey conducted in late 2012 among 450 global subject matter experts and senior participants who make up BioPlan’s Biotechnology Industry Council confirmed that a leading 24% of bioprocessi…
Article
Prescribing Caution for Biosimilars
Recognizing the authority US states have over biosimilar and interchangeable biologic medicines, the Biotechnology Industry Organization (BIO) developed five principles on biologic substitution that w…
Article
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