Search results for "regulatory" in Articles / App Notes
Article
Implementing QbD in Sterile Manufacturing
To gain perspective on the implementation of quality by design (QbD) in sterile manufacturing, BioPharm International spoke with Wolfgang Weikmann, vice-president quality assurance at Vetter Pharma-Fe…
Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
This Application note describes a three-step purification process of a domain antibody (Dab) expressed in the periplasm of E. coli. First, a capture step using Capto™ L was used to reduce E. coli host…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
Article
Welcome to the new Process Development Forum
August 15, 2013
Welcome to the new Bioprocess Development Forum (PDF) website.
We launched www.ProcessDevelopmentForum.com two years ago as a new channel for information relevant to research…
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…
Article
Quality Considerations for Using AI in Bio/Pharma
Schniepp, distinguished fellow at Regulatory Compliance Associates, stresses that a robust quality management system and document control are necessary when adding AI to a process. “I also worry about…
Article
Moving Biosimilars Forward in a Hesitant Market
“There’s so much work that goes into demonstrating, analytically, that a product is comparable or similar to its reference product in order to achieve that type of regulatory approval,” Gabrielson sta…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
“The availability of trained, regulatory-compliant GMP manufacturing staff and quality control and quality assurance personnel is a critical success factor,” he says. Much investment in facilities wil…