Search results for "manufacturing"
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Success demands consistent discipline and rigor from supply chain and manufacturing operations, as well as programs and procedures that mitigate risk and variability.
This article discusses effo…
Poster
FlexFactory™ Automation
This automation platform is the foundation of the flexible, configurable, and scalable FlexFactory biomanufacturing solution. The FlexFactory biomanufacturing solution can be delivered as either an in…
Article
Process Chromatography Selection for Downstream Processing Applications
Protein A enables a platform process for mAbs thus enabling higher throughput of projects through process development and manufacturing.
BioPharm: What are some common chromatography column issues…
Article
Generating a Fully Processed Antibody
…ds to be stable through the cell-line development, subsequent scale-up, and eventually, large-scale manufacturing. Because balancing ratios of individual proteins is so crucial for these types of pro…
Article
Biosimilars: Making the Switch Comes with Challenges
If necessary, the manufacturing process would be adjusted to achieve the QTPP.
The focus would be comparisons of in-vitro studies to characterize extensively the functions and activity of the mole…
Article
Reporting Quality Metrics to FDA
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), specializing in chemical synthesis of APIs. Since the publication of FDA’s draft guidance, Request for Quality Metrics, …
Article
Selecting the Right Viral Clearance Technology
… approach generally used to understand the clearance potential of a step that will be included in a manufacturing platform.
Lot-to-lot-variation in both product feedstocks and consumables is anot…
Article
Robust Optimization, Simulation, and Effective Design Space
In reference to modern drug development ICH Q11, Development and Manufacture of Drug Substances states (2):
“Risk assessment can be used during development to identify those parts of the manufactu…
Article
Ensuring the Quality of Biologicals
The rationale is that there is a direct relationship between glycosylation and the manufacturing process. This new approach is aligned with the development approach for biosimilars and involves commun…
Article
Drug Discovery and Development in India
…f Pharmaceuticals Pharma Vision 2020 (7), which is designed to make India a hub for end-to-end drug manufacturing. He says, “To encourage greater participation from industry players, the government m…