The implementation, maturation, and benefits of single-use technologies in biopharmaceutical development and manufacturing are well documented and understood. As analytical methods and testing services also rapidly improve, it is clear that management of risk associated with extractables and leachables also must evolve. Standardization is universally accepted as a goal; how to define, implement, and educate the industry is where debate resides.
The container–closure segment has had more experience dealing with leachables and extractables than those implementing single-use process components do — they’ve just been doing it longer. BPI takes a closer look at relevant guidance and regulations and examines how groups such as BPSA, ELSIE, ISO, and USP are helping users make sense of it all.
This eBook reviews the industry’s approach to leachables and extractables to address an underlying question: How close are we to making standardization a reality?
Read an excerpt from the eBook below:
“E/L testing and risk mitigation always were complex scientifically. But
by 2017, they have become a mega-issue for biopharmaceutical developers.
The subject occupies an alphabet soup of organizations and committees
attempting to set standards, make recommendations, and issue guidances.
From these activities has sprouted a significant and growing follow-on
industry of regulatory consultants, analytical laboratories, conferences,
reports, and independent pundits. From that apparent chaos, a consensus
is slowly emerging.
Among organizations claiming to speak for science and safety are the
American Association for Pharmaceutical Science (AAPS), the Bio-
Process Systems Alliance (BPSA), the BioPhorum Operations Group
(BPOG), the Extractables and Leachables Safety Information Exchange
(ELSIE), the International Pharmaceutical Aerosol Consortium on
Regulation and Science, the Inhalation Technology Focus Group of
AAPS, the Polymer Forum, the National Institute of Standards and
Technology (NIST), and the Product Quality Research Institute
Thanks to those groups — and the industry’s cautious embrace of
regulators’ forward-looking position on risk — biopharmaceutical
developers are beginning to understand that more testing does not
necessarily guarantee higher quality or safety. And polymer suppliers
recognize that drug containers are very different from car seats. All
stakeholders know that reaching a consensus on how to deal with E/L
will require borrowing the best ideas from multiple expert sources.”