Search results for "biopharm"
Article
Advancing Single-Use Technology Through Collaboration
By Cheryl Zigrand
The use of disposable, single-use components within the biopharmaceutical manufacturing process is not a new phenomenon. Silicone tubing, capsule filters, tissue culture flasks, …
Article
Framing Biopharma Success in 2016
Peters
The US biopharmaceutical industry turned a new page in 2015 when FDA approved Zarxio (filgrastim-sndz), the first biosimilar approved for use in US markets, in March 2015. Biotechnology sto…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
…will still be the subject of significant litigation in years to come, she said in an interview with BioPharm International.
Pre-litigation steps for biologics has been set out by the BPCIA, where…
Article
SEC in the Modern Downstream Purification Process
Kevin O'Donnell
BioPharm International
Volume 3, Issue 28
Since the introduction of commercial chromatography resins approximately six decades ago, size-exclusion chromatography (SEC) ha…
Article
Viral Clearance Challenges in Bioprocessing
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitious and endogenous viruses have traditionally been achieve…
Article
Setting Standards for Biotech Therapeutics in India
Singh
BioPharm International
Volume 11, Issue 27, pp. 35-40
The past decade has seen considerable growth in the Indian pharmaceutical industry. India has emerged as a key supplier of high…
Article
DoE Provides Benefits, but Preparation Is Necessary
An added benefit of this efficiency, Yang notes, is the reduced quantity of material needed for formulation development, which can be important early in the development of a biopharmaceutical product …
Article
Application of Quality by Design to Viral Safety
Oct 1, 2014
BioPharm International
Volume 27, Issue 10, pp. 40-47
The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the quality of biopharmaceutical…
Article
Challenges of Protein Aggregation During Purification
Sep 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 27, Issue 9, pp. 32-35
Removal of protein aggregates from biologic APIs is crucial due to their potential to incre…
Article
2014 Manufacturing Trends and Outlook
In a recent survey of current trends and practices in biopharmaceutical manufacturing, BioPharm International readers revealed a preference for disposable systems, identified challenges for different …