Phorum

Development Group

Deliverables

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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