Formulation paper supporting harmonization of drug product robustness studies
As part of the BPDG Formulation Point Share activities, an intercompany collaboration exercise was performed that included a bench-marking survey and extensive group discussions around the scope, design, and execution of biopharmaceutical drug product robustness studies. The Point Share has now published key common themes as “An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies” in the Journal of Pharmaceutical Sciences. It is hoped the paper will have a significant impact on harmonizing biopharmaceutical development practices.
The paper, which was published in the February issue, is now featured by the editorial team on the front page of the website.
Formulation and manufacture robustness studies are essential to developing robust pharmaceuticals that ensure the quality of the product administered to the patient. However, previously there was little guidance, literature or even agreement on the scope, design and execution of these studies.
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.
For a short time only this article is available free by following this link to Science Direct.