An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies

The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-F...

Full description

Saved in:
Bibliographic Details
Published in:Journal of pharmaceutical sciences 2018-02, Vol.107 (2), p.529-542
Main Authors: Morar-Mitrica, Sorina, Adams, Monica L., Crotts, George, Wurth, Christine, Ihnat, Peter M., Tabish, Tanvir, Antochshuk, Valentyn, DiLuzio, Willow, Dix, Daniel B., Fernandez, Jason E., Gupta, Kapil, Fleming, Michael S., He, Bing, Kranz, James K., Liu, Dingjiang, Narasimhan, Chakravarthy, Routhier, Eric, Taylor, Katherine D., Truong, Nobel, Stokes, Elaine S.E.
Format: Article
Language:English
Subjects:
biopharmaceutical
design space
drug product
formulation
manufacturing process
quality by design
robustness
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share group conducted an intercompany collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The BPDG-Formulation Point Share discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2017.10.017