As part of the BPDG program, we are running twelve collaboration point shares. The benefits of membership to the Development Group include a shared experience via case study presentations, publication of white papers and benchmarking surveys on a wide range of topics such as Managing Breakthrough, Facilitating Post-approval Changes, First in Human, CMC Management, Outsourcing, Automation in PD, QbD and Process Characterization, Cell Line Technologies, Molecule Selection.
Some of the targeted benefits include:
Analytics – Sharing the development of high throughput (HT) and automated analytical techniques to support HT knowledge build for the various companies.
Formulation – Published a scientific paper on drug product robustness and presenting it at various 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, presenting it at the BEBPA conference in 2016 and 2017. This has been published in a two-part article in BioProcess International and a toolkit developed to sit alongside.
Demonstration of Monoclonality – Co-developing an experimental protocol with several companies pooling their experimental data for statistical analysis into monoclonality. Planning to publish a white paper covering approach to qualifying imaging technologies.
Viral Clearance – Publishing a scientific paper on generic viral claim to leverage small virus strategy based on multiple company data and presenting it at various conferences in Europe, North America and Asia. Developing a second paper to show that appropriately cleaned chromatography resins maintain viral clearance as predicted by performance attributes and presenting it at conferences.
Qualification of Scale Down Models – Focusing on the Upstream and Downstream aspects of Scale Down Model Qualification and sharing case studies on approach to scale down model qualification which is supported by in depth round table discussions.
Additionally, the group is collaborating on Forced degradation studies, Bioassay, CMC Regulatory, CMC Considerations for Expedited Development Programs and Development Outsourcing.
Process Development and Regulatory functions of BioPharmaceutical companies.