Further Enhances Pfizer’s Collaborative Effort to Help Establish
PCMM as Industry Standard in Continuous Processing
Pfizer Inc. (NYSE:PFE) announced today a multi-year collaboration with
GSK on the development of a next-generation equipment design, building
upon Pfizer’s existing portable, continuous, miniature and modular
(PCMM) prototype for oral solid dose (OSD) pharmaceutical development
and manufacturing.
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Pfizer’s current PCMM prototype is an autonomous and transportable pod
that may be quickly shipped from location to location and readily
brought online to create a fully functional module that is compliant
with industry-standard good manufacturing practice (GMP) guidelines.
Together with GSK, which has notable technical and regulatory experience
in continuous processing, Pfizer will conduct coordinated experiments to
create the next-generation design of Pfizer’s current PCMM prototype.
This collaboration expands upon Pfizer’s existing collaboration with GEA
and G-CON Manufacturing, which resulted in the design of the current
prototype unit presently implemented at Pfizer’s labs in Groton, Conn.
“Pfizer’s success in building a first-of-a-kind, transportable, modular
prototype for oral solid dose pharmaceutical development and
manufacturing holds promise to help transform industry practices, and we
invite other organizations to join us in this effort,” said Rod
MacKenzie, senior vice president, PharmaTherapeutics Research &
Development at Pfizer. “We believe coupling Pfizer’s industry-leading
development and manufacturing capabilities with GSK’s experience and
expertise in continuous processing has the potential to lead to a
superior technology, thereby allowing us to more quickly and efficiently
bring therapies to patients.”
“GSK is pursuing a strategy to enhance our manufacturing supply chains
and drive access to medicines for patients. Continuous manufacturing is
a key part of that strategy,” said Mark Buswell, Vice President and Head
of Advanced Manufacturing Technologies at GSK. “This strategic
collaboration allows Pfizer and GSK to align on a vision for PCMM-OSD
equipment designs and enables us to deploy flexible, agile and reliable
manufacturing solutions to benefit patients.”
About Pfizer’s PCMM Technology
Pfizer’s PCMM technology is a first-of-a-kind manufacturing system that
accelerates the speed of tablet production. The pharmaceutical industry
has been trending toward lower-volume products, driven by an increased
focus on precision medicine approaches to develop and commercialize new
therapies. This creates a need for smaller, more flexible continuous
processing technologies.
By miniaturizing the equipment, the continuous process can be enclosed
in a portable, autonomous space called a POD, which can be transported
to any location in the world and quickly assembled.
The PCMM technology has the potential to transform the current
biopharmaceutical industry standard of using batch processing to
manufacture tablets and capsules from powders—an oftentimes complex
process that requires large, dedicated manufacturing facilities. The
PCMM continuous process takes only minutes from the addition of raw
materials to the completion of finished tablets or capsules.
Highlights of PCMM’s potential for smaller, more flexible, continuous
processing technologies include:
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A PCMM facility has a 60 to 70% smaller footprint than a conventional
production facility.
-
PCMM enables use of the same equipment for development, clinical
trials and commercial manufacturing.
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A PCMM facility takes about one year to set up and start running,
compared to two to three years for standard processes.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. To learn more, please visit us at www.pfizer.com
Disclosure Notice: The information contained in this release
is as of October 29, 2015. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information about Pfizer’s
collaboration with GlaxoSmithKline (GSK) on the next-generation
equipment design of Pfizer’s portable, continuous, miniature and modular
(PCMM) prototype for oral solid dose pharmaceutical development and
manufacturing, including Pfizer’s plans and prospects for PCMM
technology and its potential benefits, that involves substantial risks
and uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties inherent in
research and development; risks related to the ability to realize the
anticipated benefits of the collaboration with GSK and PCMM technology,
including the possibility that the expected benefits from such
collaboration and PCMM technology will not be realized or will not be
realized within the expected time period; other business effects,
including the effects of industry, market, economic, political or
regulatory conditions; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2014 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
its subsequent reports on Form 8-K, all of which are filed with the SEC
and available at www.sec.gov
and www.pfizer.com.
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