Taking the Pulse of Emerging Technology in Continuous Manufacturing
Christine M. V. Moore, PhD
I am eagerly anticipating the upcoming 2018 ISPE Continuous Manufacturing Workshop to be held June 6 & 7th in Arlington, Virginia immediately following the 2018 ISPE Quality Manufacturing Conference. This workshop will provide a snapshot of today’s landscape for continuous pharmaceutical manufacturing of small molecules drug substances and drug products, and examine the ongoing and future activities to further progress the field. The content will be informative to both experts and novices in the field and will cover all major aspects of continuous manufacturing including development, quality assurance, regulatory, and manufacturing. I consider it to be a great honor to be the chair of such an important event around a technology that could revolutionize pharmaceutical manufacturing.
In the past 2 years, since the first ISPE Continuous Manufacturing Workshop, several advances have been made in the field, including:
At least three FDA approvals of drug product continuous manufacturing products
Approval of several drug substance continuous unit operation processes
The transition from batch manufacturing has not necessarily been an easy one, with the first practitioners overcoming equipment issues, an unknown regulatory landscape, and organizational biases of “we’ve always done batch”. We anticipate that attendees will walk away from these two days better equipped to deal with the technical, regulatory, and organizational challenges associated with implementing this new technology.
The 2018 ISPE Continuous Manufacturing Workshop will bring together the early adopters of the technology to share their learnings from implementing continuous manufacturing for pharmaceutical drug substances and drug products. In addition to traditional podium sessions, the lineup includes several interactive round table discussions where panels of industry experts and regulators will share their experiences and answer questions from the audience. We have also included academics who will share the exciting contributions and future directions of the dozens of universities involved in continuous pharmaceutical manufacturing research.
Multi-Use Filling Line for RTU Syringes, Vials, Cartridges and Bulk Vials - Photo courtesy of INCOG BioPharma Services
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