Search results for "regulatory" in Articles / App Notes
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…
Article
Single-Use and Continuous Processing Technologies Change Facility Design
Viewing Changes in Pharmaceutical Facility Design
Single-use systems, continuous processing and isolator technology use a smaller footprint. Experts predict how the facilities of the future may …
Article
A Q&A With Parrish Galliher About Adopting Single-Use Systems
This week, Process Development Forum speaks with Parrish Galliher, Chief Technology Officer Upstream at Cytiva, about trends within the bioprocess area.
What’s one of the biggest t…
Article
FDA Urged to Preserve Biosimilar Naming Conventions
The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have …
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…