Search results for " meeting"
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
According to the agency, to participate in the new FDA program, applicants must submit a written request for a Type C meeting to CDER-ETT@fda.hhs.gov. Requests can include an explanation of the new te…
Article
GMP Challenges for Advanced Therapy Medicinal Products
The meeting also acknowledged that the term “GMP grade” meant different things to different groups, according to an EDQM report on the conference (5).
Adapting GMP implementation based on risk
S…
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
Article
Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
Article
Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …
Article
USP Stresses Pharmacopeial Standards at CPhI China
Jun 29, 2015
By BioPharm International Editors
The United States Pharmacopeial Convention (USP) hosted a pharmacopeial and regulatory compliance seminar at the 2015 CPhI China conference, he…
Article
What’s In a Name? For Biosimilars, A Lot
Jun 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 6
There is still some uncertainty surrounding whether a biosimilar will share the same compendial identity—or …
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
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
SEC in the Modern Downstream Purification Process
…ich on the 5- to 10-L scale indicated previously, would be enough to generate sufficient product for meeting the annual needs of a company. The low-cost/low-complexity use of SEC resins in single-use…