Search results for " learning" in Articles / App Notes
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
Article
Early Communication with Regulators is Essential for SMEs
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
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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
Climate Change in Outsourcing
Further, business-development practices in the US differ from those in Europe, so European CMOs could face a long learning curve trying to get established in North America.
The European interest c…
Article
ReadyToProcess WAVE 25 Bioreactor System
The single-use ReadyToProcess WAVE 25 bioreactor system is a reliable and intuitive cell culture device for working volumes up to 25 L.
The system is based on a well-known rocking technology tha…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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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)…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Interested in learning more? For more insight into what the FDA is planning, check out the 2013 FDA list of guidance documents.