Search results for " GMPs"
Article
Good Manufacturing Practices: Challenges with Compliance
Gaps in GMPs
BioPharm: Where are the gaps in GMPs where guidance is still needed?
Cohen (Lubrizol): Further guidance is still needed on quality control and analytical methods. There is a bri…
Article
Gowning Practices Provide Clues to cGMP Compliance
…Do you need to gown and de-gown just to get to a desired destination?
Regulatory guidelines for GMPs include straightforward statements, but the application of cGMPs to a facility is not so simp…
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
Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
That includes careful selection of equipment and starting materials with scalability and manufacturability under current GMPs taken into consideration and being guided by data, not perception.
“The…
Article
Implementing Inline Conditioning to Advance Process Intensification
Buffer preparation is still a highly manual activity that often requires a lot of resources due to the large number and overall volume of buffers. With inline conditioning buffers can be prep…