Search results for " supply" in Articles / App Notes
Article
Single-Use and Continuous Processing Technologies Change Facility Design
With technology development ongoing, prices are still relatively high and the supply chain has not been totally optimised, but in 10 years, SU will be more widely accepted.
In parallel, another ch…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
One approach of decreasing feed volumes but still stoichiometrically supplying nutrients to cells is to concentrate the feed media. The preparation of highly concentrated feed media is, however, chall…
Article
Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
Article
Bioprocessing Advances in Vaccine Manufacture
stainless steel) for their application in precommercial R&D, clinical-trial-material supply, and commercial manufacture. This use of SUS is projected to result in the market (primarily US and EU) for …
Article
Supplier-Change Management for Drug-Product Manufacturers
…urers can ensure that their collaborations improve the product while avoiding unnecessary product or supply risks to the patients who depend on them.
Reference
1. The International Pharmaceut…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
This is particularly true in manufacturing, where they are the experts in the technologies and processes they use—and the first line of defense to assure the uninterrupted supply of high-quality produ…
Article
Operational Excellence: More Than Just Process Improvement
…rk by reducing waste, streamlining processes, increasing productivity, and assuring an uninterrupted supply of products to customers. In addition to increased efficiency and cost reduction, there is …
Article
QbD and PAT in Upstream and Downstream Processing
Issues arise when one goes to volumes greater than 1000 L and when it increasingly becomes more difficult to strip off the CO2 generated by the cells and in ensuring uniform supply of O2 and other cri…
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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)…