Search results for " CGMP" in Articles / App Notes
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…
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…
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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…
Article
Understanding Validation and Technical Transfer, Part I
The 1978 CGMP regulations (4) discussed validation in terms of automatic, mechanical, and electronic equipment (21 CFR § 211.68), validation of supplier’s test results for components, drug product con…
Article
The New World of Biopharmaceutical Manufacturing
An initial focus on small-batch clinical trials has expanded to full-scale cGMP commercial production. More recently, drug manufacturers are using fully closed systems to make multiple drugs in large …