Search results for " conference" in Articles / App Notes
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
Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 6
The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…
Article
Host-Cell Protein Measurement and Control
Regulatory Requirements for HCPs Measurement and Control
According to International Conference on Harmonization (ICH) guidelines Q6B, “For host-cell proteins, a sensitive assay (e.g., immunoassay,…
Article
Optimization of Protein Expression in Escherichia Coli
May 01, 2015
By Siavash Bashiri, David Vikström, Nurzian Ismail
BioPharm International
Volume 28, Issue 5
Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…
Article
Securing the Single-Use Supply Chain
“At any conference with single-use as a topic, you can find a case study or conversation about a single-use component being changed with either no prior notification or inadequate notification to the …
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
Following his keynote presentation to attendees at the recent HTPD Conference in Italy, Arne Staby, PhD, Fellow, Novo Nordisk, Denmark, spoke to Process Development Forum about why he prefers mechanis…
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Setting Standards for Biotech Therapeutics in India
IPC and USP have been working closely together and organize an annual conference to share updates and ideas. Similar relationships need to be pursued with other global agencies such as National Instit…
Article
DoE Provides Benefits, but Preparation Is Necessary
In addition, a DoE-driven approach meets the International Conference on Harmonization Q8 guidelines for multivariate design space and the subsequent justification of formulation components when devel…
Article
Application of Quality by Design to Viral Safety
This approach uses the concepts laid out in the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines, Q8 Pharmaceutical Development, Q9…