Single-Use-Systems: Leachable Study Design for Single-Use Components

The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharmaceutical and Vaccines Manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the Best Practices for Leachables Study Design by end users and will include a case study to highlight the importance of the study design.
Presented by Kathryn McGohan
Kathryn McGohan is a Scientist I within the Materials Science group of the Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb. Kathryn is responsible for the selection, qualification, and validation of single-use products for use in late stage development and commercial biopharmaceutical manufacturing processes (U.S. and ex-U.S.). Kathryn also supports the authorship of CMC regulatory filing sections, new product launches, and continuous improvement efforts. Kathryn currently represents Bristol-Myers Squibb on the BioPhorum Operation Groups (BPOG) Disposables Workstream.
 
 
 
Sponsored by Pall Biotech

 
Successes and Ongoing Challenges with Implementation of Single Use Extractables Datasets
Establishing consistent, high caliber expectations for component extractables data has been a major industry focus intended to streamline and accelerate the adoption of single use components.  In this overview we will share lessons learned in execution of more than 17 studies using the BPOG protocol as well as limited studies using the USP <665> draft protocol.  In addition, we review current challenges and potential solutions associated with compiling extractables datasets from multiple suppliers to perform comprehensive risk assessments on single use processes, as well as approaches to risk assess low to medium risk components for which detailed extractables studies are not available.  The aim of this review of experiences to date is to drive further industry alignment among suppliers, end users and regulators that accelerates the adoption of single use technologies and serve the public good.
 
Presented by Dr Hélène Pora and Dr James Hathcock of Pall Biotech
Dr Hélène Pora is Vice President Single Use Technology within Pall Life Sciences, where she has the global responsibility for the marketing and development of Pall single use technologies. Hélène has been instrumental in the development of Pall single use technologies for the last 20 years. She is as well heavily involved in quality and regulatory aspects of single use technology. Hélène has over 30 years of experience working for the biopharmaceutical industry, the last 26 years within Pall Corporation.
She speaks regularly at conferences about single use technology with a strong focus on validation and over all process integration aspects, she is as well involved in different working groups in the industry involved in standards development and is on the board of BPSA and SUTAP.
 
Dr. James Hathcock is Senior Director of The Regulatory and Validation Consulting Team at Pall Life Sciences, which includes responsibility for the extractables and leachables characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing.   He is an active member of ASTM, PDA, ISPE, BPSA and the USP <665> expert panel. Since joining Pall in 2008, James has led chemical and performance characterization of Medical and Biopharmaceutical products, as well as relevant technical packages supporting regulatory filings. Prior to joining Pall, James was a professor of hematology at the Mt. Sinai School of Medicine in New York City, where he served as director of the protein purification core laboratory.
 
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