Development Group

BioPhorum Development Group’s mission focuses on better and faster process development of biopharmaceutical medicines. Formed in 2011, the Phorum 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.

Workstreams

Analytics
Bioassay
Cell Line Development
Accelerate CMC Development to Marketing Application
CMC Regulatory
Development Outsourcing
Forced Degradation Studies
Formulation
Host Cell Proteins & other Bio-Residual Process Related Impurities
In-Silico Strategies
PAT Monitoring and Control
Qualification of Small Scale Models
Viral Clearance
Focus Group: Applied Automation

Benefits

Forced Degradation

The common practises paper “An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals” was selected and published in a special edition of J. Pharm. Sci.

Formulation

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

A CSTD subteam has drafted a publication on the strategy to design compatibility studies for CSTDs.

A clinical in-use paper is being drafted

Host Cell Protein

Ongoing collaboration with USP on Mass spectroscopy methods and standards, evaluating the need for physical standards for identification and quantification of host cell proteins. Currently focusing on a multi company publication on High Risk HCPs and genetic stability and associated regulatory aspects.

Bioassay

Recently published “Best Practice in Bioassay Development to Support Registration of Biopharmaceuticals” downloaded more that 10,000 times from Biotechniques.

The paper looks at tactical and strategic considerations for assay design and covers fundamental practical aspects of modern potency assays.

Viral Clearance

An article has been published in the PDA Journal. It aims to show that appropriately cleaned chromatography resins maintain
viral clearance as predicted by performance attributes. Annual tracking of the adoption of recommendations takes place to understand outcomes for future collaboration with regulators.