Search results for "regulatory"
Article
Vaccine Development and Production Challenges Manufacturers
Mar 01, 2015
By Jill Wechsler
BioPharm International
Volume 3, Issue 28
Vaccines are front-page news these days. Researchers are advancing new vaccines for Ebola and other devastating di…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Fermentation for the Future
Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have b…
Poster
Accurate comparability assessment of a biosimilar interferon in process development
This application note describes how to achieve accurate comparability assessments using Biacore™ T200 and
Amersham™ WB system in the development of a biosimilar. This is exemplified in this study…
Article
What Drove Biopharma Development in 2014?
Process Development Forum (PDF) featured a myriad of topics at the forefront of biopharmaceutical development. But some issues stood out as garnering the most attention from readers in 2014. One of …
Article
Setting Standards for Biotech Therapeutics in India
Unlike a lot of developing and developed countries, the standards stated in the IP are authoritative and legally enforceable by the Indian regulatory authorities (CDSCO and State Drug Regulators). In …
Article
DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist t…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implementi…
Article
Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies.
Sep 1, 2014
By: Jane Wan
BioPharm International
Volume 27, Issue 9, pp. 8-12
On March 25, 2014, the…
Article
A Q&A With Phil Lester, co-organizer of the HTPD Conference
The 3rd HTPD Conference will take place this October, in Siena, Italy. Process Development Forum spoke with Phil Lester, one of the principal organizers of the conference.
PDF: This is the third…