Projects selected for the Facility Integration Award have applied good design practices and superior conceptual planning to their projects resulting in excellent integration of facility and process in an efficient, clean, pleasant environment. The projects have also merged process and building to create an environment of form and functional excellence.
The Andover Clinical Manufacturing Facility proves that a sustainable, flexible, configurable, and wireless clinical manufacturing facility can achieve complete integration into a dynamic, high-performance process development flow today and preserve that integration no matter how biologic drug development may evolve in years to come.
Pfizer is a research-based, global pharmaceutical corporation founded in 1849. One of the world’s largest pharmaceutical companies, Pfizer discovers, develops, and manufactures health care products including medicines and vaccines for a wide variety of illnesses as well as many of the world’s best-known consumer healthcare products. With their new facility located on their master-planned 70-acre Andover, Massachusetts, campus they set out to build a new, state-of-the-art clinical manufacturing facility to house existing clinical manufacturing capabilities and provide room to support the growing portfolio demands of Pfizer’s new GMP-compliant, clinical bulk drug substance, biological products.
Thanks to careful planning and astute attention to detail the facility blends in seamlessly with the rest of the campus and they were able to relocate existing manufacturing capabilities from Chesterfield, Missouri, to the new Andover facility which allowed them to integrate research and development and expand biological products from 14 campaigns to a future maximum capacity of 21.
The 5-story building houses 5 independent manufacturing suites dedicated to the development of new biotherapeutics and vaccines to support trials in disease areas including oncology, rare diseases, infectious diseases, hemophilia, and rheumatoid arthritis. Each suite operates completely independently of the others and all 5 can operate simultaneously. To reduce the risk of cross-contamination, there are no crossties between the suites. The required physical connections to upstream and downstream processes are accomplished by the most fundamental of flexible facility integration strategies – a network of lower classification corridors enabling unrestricted media and buffer moves via totes and pass-throughs rather than transfer lines. In fact, there is almost no fixed equipment deployed in the ACMF – almost everything is on wheels or skids.
Pfizer developed a unique strategy of flexible facility integration for ACMF that includes:
Ability to run both microbial and mammalian processes
All media and buffer moves are made with totes, reducing transfer time by 70%
Have both single-use plastic and stainless-steel technology suites
All suites are configurable
Additionally, Pfizer promotes exchange of knowledge and skills with formal cross-staffing programs which place commercial manufacturing personnel in clinical manufacturing roles. Pfizer’s Historian captures data and information generated by all process development activities at the Andover campus and provides site-wide access to the lessons-learned.
“The flexibility of the facility and the ensuing relationships with collaborating teams have enabled us to complete technology transfer of complex processes within 2 months,” said Lauren Gomes, Director, Clinical Manufacturing, Pfizer. “One of our upcoming projects will be producing a drug substance for pandemic supply of the COVID-19 mRNA vaccine.”
ISPE congratulates Pfizer on the success of their Andover Clinical Manufacturing Facility, their achievements in advancing research and development and their FOYA award winning entry for Facility Integration. Learn more about the 2020 FOYA Facility Integration winner.
Has your company recently designed, built or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class?
ISPE is now accepting entries into the 2021 ISPE Facility of the Year Awards (FOYA) Program, and your facility may be eligible to apply. Learn more about the Facility of the Year Awards submission process and your company could be the next Facility of the Year Awards Category winner. Nominate your facility in 2021
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