Development Group

Our goal is to support the industry in its quest for better and faster process development.

 

The BioPhorum Development Group (BPDG) started in 2011. The BPDG brings the benefits of our collaboration approach to the drug development community which has enormous challenges given the proximity to IP. Despite this, BPDG has worked out how to successfully connect process development organizations and provide a space where subject matter experts (SMEs) collaborate on shared issues and look to accelerate improvements across the process development arena.

 

BENEFITS:

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 – Publishing 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 and looking to publish It.

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.

 

MEMBERS INCLUDE:

Process Development and Regulatory functions of BioPharmaceutical companies.

 

PHORUM INFLUENCE (PI):

 

 

 

PUBLICATIONS: 

An inter-company perspective on biopharmaceutical drug product robustness studies” in the Journal of Pharmaceutical Sciences

Posters for BEBPA conference in 2016 and 17.

Viral clearance study comparison

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