Search results for " meeting" in Articles / App Notes
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
Editors’ Note: This article is based on a topic addressed during the 6th Pharmaceutical Inspection Co-operation Scheme (PIC/S) Expert Circle on APIs meeting, held in Rome in May 2014 and hosted by the…
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Biomanufacturing Outsourcing Globalization Continues
May 02, 2015
By Eric S. Langer
BioPharm International
Volume 28, Issue 5
Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America …
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
Article
Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
Navigating Emerging Markets: Middle East and North Africa
The lobbying group does note that it is encouraged by the Minister of Health’s announcement at a PhRMA meeting that the government would reduce the review time required for marketing authorization and…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
AAPS Annual Meeting. 2007.