Search results for "biopharm" in Articles / App Notes
Article
New Era for Generic Drugs
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue 27, pp. 8-10
The 30th anniversary of the Hatch-Waxman Act in September generated widespread recognition of how the leg…
Article
Continued Process Verification for Biopharma Manufacturing
Oct 1, 2014
By: Jeff Fleming, Robin Payne
BioPharm International
Volume 27, Issue 10, pp. 48-52
Continued process verification (CPV) is the activity that provides ongoing verification…
Article
Healthcare Reform in China
Sep 1, 2014
By: Jane Wan
BioPharm International
Volume 27, Issue 9, pp. 8-12
On March 25, 2014, the Chinese government announced a string of initiatives in a continued move to overhau…
Article
Evaluating Design Margin, Edge of Failure and Process
Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or process’ design space is generally considered to be the area where process parameters safely (without fail…
Article
Relationship Building at Top of Mind for Clients
Aug 1, 2014
By: Eric Langer
BioPharm International
Volume 27, Issue 8, pp. 12-14
Contract manufacturing organizations (CMOs) should have the technical expertise to be considered by clients…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
Challener is a contributing editor to BioPharm International.
Article
Global Expansion Shapes Drug Oversight
Few FDA officials discuss pharmaceutical regulation these days without reference to how the international reach of the biopharmaceutical industry has altered drug research, production, and regulation.…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
Drivers for adoption
The success that biopharmaceutical manufacturers have had with single-use technologies for upstream applications is providing significant impetus for their application to down…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
“The Sf9/BV genetic engineering technology is now well established in the biopharmaceutical industry, and has for example been used for the production of a licensed human papilloma virus vaccine and a…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
“Since 2002, we have made significant investments in facilities, human resources, and technology to become a global and innovative biopharmaceutical company,” he says.
Need for clear regulatory pa…