Thursday, April 2, 2015

BDP Week 2015: Extractables and Leachables

By: Maribel Rios, Managing Editor of BioProcess International

On Tuesday afternoon, 31 March 2015, the single-use track of the BioPharmaceutical Development and Production (BDP) Week meeting in Huntington Beach, California, focused on the challenges associated with particles and extractables and leachables (E&L). Bobbijo V. Redler, PhD (Merck & Co., Inc)  began by defining the terms and the different types of E&L studies, including controlled extraction studies (screening), simulation studies, leachables testing (using methods validated for registration), and routine monitoring (also using validated methods). She reviewed simulated study designs, the use of various analytical techniques for E&L studies, and efforts of the E&L team of the BioPhorum Operations Group (BPOG).

James Vogel (The BioProcess Institute) presented on the work of the Bio-Process Systems Alliance (BPSA) on its 2014 particulates technical guide, “Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Processing Equipment.” The 12-chapter compendium is targeted for both end users and supplies of single-use components and systems. The session ended with a roundtable moderated by Redler. Panelists included Weibing Ding (Biogen Idec), James Vogel, and Michael Rupperto, PhD (Material Needs Consulting). The session consisted of a Q&A with attendees. Various issues were discussed, including the following:

·         Whether the BPOG extractables protocol published last year (Ding W, et al. Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing. Pharm. Eng. Nov-Dec. 2014) actually is a “best practices” document and if it truly can be used for “comparability.” Panelists said that the protocol does provide some flexibility, the document is a “step forward,” and that ASTM (Association for Standards Testing and Materials) and USP (US Pharmacopeia) Chapter <661.3> work is ongoing.

·         Whether it is better to discontinue use of a component is easier than to conduct continuous monitoring for extractables. The panel answered that the decision is often a matter of time and cost and that the material may have unique properties that are needed.

·         How to determine a threshold for extractables information and the definition of BPA-free. The panel emphasized the importance of smart material selection, paying close attention to materials, including secondary packaging, and continually assessing risk.

·         Whether the BPOG protocol (above) should actually be more rigorous. The panel mentioned that not many company are conducting in-process leachables testing for process equipment, reminding attendees that suppliers are responsible for extractables tests and end users are responsible for leachables testing. The general intention is to get single-use implemented quickly. 

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