Search results for " CGMP"
Article
Biomanufacturing Outsourcing Globalization Continues
This trend is changing, as domestic CMOs focus on being able to meet full US and EU cGMP standards and be allowed to manufacture commercial products for those markets.
Michael Yu, president and CE…
Article
Quality by Design and Extractable and Leachable Testing
Confirmation that the supplier has cGMP control over its manufacturing process is essential. Once variability is known, one can assess the impact of this variability on component leachables, and in tu…
Article
Report from the 6th International HTPD Conference
However, when working in a cGMP environment, these challenges become even more important to tackle.
Analytics is still a challenge in HTPD work
The challenge of having access to sufficie…
Webcast
Xcellerex™ X-platform bioreactor live virtual demo
Whether in pilot or cGMP facilities, the modular and application-based approach improves cell culture productivity.
In this virtual workshop Ken Clapp will explain how we developed the Xcellerex™ X…
Article
What is process development?
What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recomb…
Article
Maximum Output Starts with Optimized Upstream Processing
“If you think broadly, from process development to clinical to CGMP [current good manufacturing practice] production, advances in digital solutions are accelerating the pace of drug development. Valid…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
By Feliza Mirasol
The advancement of digit…
Resource
Mechanistic Modeling: Theory to Implementation
Gain a better understanding of effective modeling implementation to develop robust lab scale processes, enabling smooth scaling into cGMP manufacturing.
Article
Flexible Facilities for Viral Vector Manufacturing
Single-use and modular systems will meet demand for rapid implementation at different scales.
By Jennifer Markarian
Industry experts have noted that there are limitations in the…
Article
Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…