Posted on: 10th August 2018

Following positive feedback on its recently published paper, the Formulation point share in Development Group is sharing presentations and a poster at three formal meetings which outline the key benefits of the paper. It is hoped the paper will have a significant impact on harmonizing biopharmaceutical development practices.

“An intercompany perspective on Biopharmaceutical Drug Product Robustness Studies” was published in the Journal of Pharmaceutical Sciences in February 2018 and has been a been a key driver for new membership in Development Group.

The commentary uses three case studies to illustrate that the ideal robustness study design for a biopharmaceutical drug product (DP) is a balance of experimental complexity, statistical power, scientific understanding and risk assessment. Recognizing the industry challenges in this area, the Formulation Point Share group provides recommendations for best practice and hopes that the work will facilitate further industry conversations on drug development encouraging industry alignment on DP robustness studies.

This kind of industry collaboration is vital for delivering a high quality biopharmaceutical product for the great benefit of patients.

“Janssen kindly shared that it was the Formulation paper which was the deciding factor in their taking up membership,” says Elaine Stokes, Formulation facilitator, “and the positive feedback has been encouraging, showing the benefits of these types of publications within the industry. It has been described as a fantastic inter-company study.”

Valentyn Antochshuk, Merck MSD, presented a poster based on the paper at the “2018 Workshop on Protein Aggregation and Immunogenicity meeting” in Colorado on 11 August 2018.

Tanvir Tabish, Shire presented at the Bioprocessing Summit, Bioprocessing Summit, Formulation and stability stream in Boston on the 14th August.

Jim Krantz, Shire, presented at the Bioprocessing Summit, 13-17 August 2018 in Boston, MA.

Dean Liu, Regeneron, will be presenting at BPI in the Drug Product, Fill-Finish & Formulations Bioprocessing session, 6th September 2018 in Boston, MA


You can access the poster here and the paper is available to subscribers of Journal of Pharmaceutical Sciences here.

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