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

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 6000 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.

workstreams

face-to-face meetings

external publications and presentations

active participants

member companies

Share This

Share this post with your friends!