Overview

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Development Group’s (DG) mission focuses on better and faster process development of biopharmaceutical medicines.  Formed in 2011, DG has succeeded in bringing collaboration to the drug development community while navigating the challenges of being close to intellectual property. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies and molecule selection.

Development Group supports the biopharmaceutical industry in its quest for better and faster process development.

 DG achieves this by

  • Connecting process development organizations
  • Providing an environment where subject matter experts collaborate on shared issues
  • Accelerating improvements across the process development arena

Benefits include:

Analytics – A technical forum to benchmark selection of appropriate methods to deliver the data in accordance with quality requirements. Build a common understanding of the level of detail required from specific assays due to tightening regulatory requirements.

Formulation – Published on drug product robustness and presenting at conferences in Europe and North America.

Host Cell Protein – Feeding back to USP, European Pharmacopoeia on new guidelines for HCP assays. Developing a risk assessment approach.

Demonstration of Monoclonality – Co-developing an experimental protocol, pooling experimental data for statistical analysis into monoclonality.

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