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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