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PHORUM

Development Group

Overview

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.

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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.

Papers

Jul 2018

Development Group Papers

Host cell proteins resource pack

You can access the Host Cell Proteins resource pack here.

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Jul 2018

Development Group Papers

Formulation

This paper provides a commentary and uses three case studies to illustrate the ideal robustness study design for a biopharmaceutical drug product[..]

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Jul 2018

Development Group Papers

High concentration formulations benchmark

A further two benchmark surveys have been developed by the team. High concentration formulations covers the challenges of high concentrations.

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Jul 2018

Development Group Papers

Surfactants in biological formulations benchmark

A further two benchmark surveys have been developed by the team. Surfactants in Biological Formulations covers the use of surfactants in biologics[..]

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Jul 2018

Development Group Papers

Analytics

The poster presented at the BPDG21 October 2017 meeting in Brussels, Belgium, shares a range of approaches to implementing USP129 Analytical Procedures[..]

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Mar 2018

Development Group Papers

Breakthrough Therapies Team Encouraged to Publish

Following our preview in the December newsletter, the Development Group's CMC Considerations for Expedited Development Point Share recently presented a poster at[..]

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Jun 2016

Development Group Papers

BPOG on display at BEBPA Conference

Along with more than 200 attendees representing the biopharmaceutical industry, vendors, and contractors, the BPOG team participated in the The Biopharmaceutical Emerging[..]

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Jun 2016

Development Group Papers

Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration

Considerable resources are spent within the biopharmaceutical industry to perform viral clearance studies, which are conducted for widely used unit operations that[..]

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News

Apr 2019

Articles

The BioPhorum and USP collaborative journey to new standards

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.

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Apr 2019

Articles

Perfecting balanced scorecards for CDMOs

Established in March 2017, the Development Group’s Development Outsourcing effort aims to share and build guidance that will help companies make the[..]

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Mar 2019

Articles

Formulation team drive for more value

Since its start in 2013, the Formulation Point Share has been busy. Its latest article, An inter-company perspective on biopharmaceutical drug product[..]

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Feb 2019

Articles

Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the[..]

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Dec 2018

Articles

2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you[..]

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Sep 2018

Articles

Plate imaging for demonstrating monoclonality published in PDA Journal

The paper is now available through the PDA and it is hoped that it will be an important offering to the industry[..]

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Aug 2018

Articles

Encouraging peer feedback for formulation

Following positive feedback on its recently published paper, the Formulation point share in Development Group is sharing presentations and a poster at[..]

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Jul 2018

Development Group News

Host cell proteins poster

This poster presented at the BEBPA Conference, San Francisco builds and consolidates the information currently available in the industry for assessing process[..]

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Jun 2018

Articles

Host cell protein risk assessment, an industry approach

Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs.

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Feb 2018

Articles

Formulation paper supporting harmonization of drug product robustness studies

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Dec 2017

Articles

CMC pointshare to share poster at CASSS presentation

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Aug 2017

Articles

BPOG’s offering is enhanced as new members join

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Apr 2017

Articles

Antibody drug conjugates and cell line technologies the focus of BPDG19

The 19th Development Group face-to-face meeting discussed antibody drug conjugates (ADC) development resulting in a valuable outputs and key learnings for the[..]

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Apr 2017

Articles

Automation of laboratory processes

The Development Group's Analytic team has shared knowledge and experience on automation of laboratory processes including bioanalytical methods, whole process automation and[..]

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Feb 2017

Articles

Formulation offers perspective drug product robustness studies

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Dec 2016

Articles

BPDG welcomes Pfizer and plans a host of industry-changing papers in 2017

The Development group have had a busy few months preparing for 2017 and are happy to report that Pfizer will be joining[..]

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Dec 2016

Articles

Quality By Design in Development Group

Quality by Design (QbD) in process development and streamlining characterization and validation, proved fruitful topics for discussion and sharing experience and best[..]

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Oct 2016

Articles

New Point Share for the Development Group

In June the Development group began a new Point Share; "CMC Considerations for Expedited Review". Expedited review is a mechanism by which[..]

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Jun 2016

Articles

Development Group on Automation and New Point Shares

Development Group held their 17th meeting in Durham, North Carolina on 14-16 June, 2016. It focused on development efficiency and automation in[..]

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Jun 2016

Articles

BPOG Members get their message out

The BPOG workstreams have been active recently in getting the fruits of their collaborations reported in the biopharmaceutical press. From April until[..]

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Apr 2016

Articles

Viral Clearance Exposure At Conferences

The Viral Clearance white paper is getting a lot of coverage in the industry, not only has it been accepted by the[..]

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Dec 2015

Articles

Development Group’s First Point Share Face-to-Face Meeting

The Formulation point share's first face-to-face (F2F) meeting, hosted by Shire at their Lexington facility in Massachusetts over 5 - 6 November[..]

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Dec 2014

Articles

Point Share ‘Viral Clearance’ – establishing technical collaboration beyond networking

One of the very effective tools available to members of BPDG is the Point Share; regular, moderated meetings, focusing on specific topics[..]

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Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

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