Photo Credit: Jacob Greenwood
CRB Wins ISPE Company of the Year, Reflecting Region’s Continued Cell and Gene Therapy Industry Growth
CRB, a global architecture, engineering, and construction firm with a large operation in Rockville, Maryland, was named the International Society for Pharmaceutical Engineering (ISPE) 2019 Company of the Year for the third time since 2000, as part of ISPE’s International Honor Awards. This award recognizes the outstanding leadership and support provided by a company as reflected by significant active participation in ISPE committees, CoPs, programs, and activities as well as its support of employee participation in ISPE.
CRB previously won Company of the Year from ISPE first in 2000, when it was the first professional services firm to win, and again in 2012, when it won for the second time.
“Since our inception in 1984, CRB has been an active supporter of top-tier technical organizations in the industries we serve…We are honored to be recognized with this award and acknowledge that ISPE’s work plays a major role in our success. Thanks to ISPE for this recognition and for being an important key to CRB’s success,” stated CRB CEO Jeff Biskup.
ISPE provides a global platform to help educate industry professionals on the latest quality standards and innovation within biopharmaceutical manufacturing. In a highly regulated industry that is experiencing rapid innovation and change, ISPE plays a critical role in advancing the standards, quality, and knowledge-sharing that are essential to the industry. CRB has committed substantial amounts of their own time, expertise, and investment to be part of those efforts at national meetings, working groups, and within individual regional chapters.
CRB has also been recognized for their work that has contributed to numerous Facility of the Year Awards (FOYA) winners. FOYA recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.
One such 2019 FOYA Honorable Mention project that contributed to CRB’s Company of The Year Award was the “Next-generation Manufacturing Facility” for a Next-generation Medicine in Chicago, Illinois. This 49,000-square-foot state-of-the-art facility was built to manufacture a proprietary investigational gene replacement therapy drug. This was one of the first manufacturing spaces in the world to scale up a gene therapy manufacturing process from an academic process to a commercial level.
The booming U.S. cell and gene therapy industry, and the rapidly growing cell and gene industry cluster within the BioHealth Capital Region (BHCR), rely on companies like CRB to deliver leading-edge, innovative, and cost-reducing facility engineering and design, that is crucial due to the complex, personalized nature of the industry’s rapidly evolving biomanufacturing processes.
CRB’s 2019 ISPE award reaffirms not only its global ISPE leadership status but also the Rockville office’s contributions to ISPE’s Chesapeake Bay Area Chapter and to the growth of the BHCR, particularly in the region’s burgeoning cell and gene therapy industry.
Over the past few years, CRB has made strong contributions to the growth of the BHCR, delivering several projects to key regional companies in the cell and gene therapy space.
In April 2019, Paragon Bioservices officially opened a new 150,000 square-foot gene therapy manufacturing facility near BWI airport in Anne Arundel County, Maryland. Paragon required this fully flexible manufacturing facility and associated spaces to be constructed in less than 12 months from project initiation. CRB’s Rockville team was able to design and construct this multiproduct, multiprocess facility predicated on maximum flexibility and adaptability while prioritizing segregation between manufacturing suites to maintain a low risk of any cross-contamination while protecting client confidentiality. This partnership between Paragon and CRB successfully executed integrated project delivery, with an aggressive timeline, to improve the speed to market. The new building provided Paragon with a unique opportunity to quickly design, construct, and qualify a new Current Good Manufacturing Practice (CGMP) commercial manufacturing facility while also providing the necessary space to grow CGMP warehouse, administrative, laboratory, and support functions.
The common challenge that most cell and gene therapy companies face is that many of their processes are still evolving or undefined, and most development and manufacturing is done using manual, open processing due to lack of automation options. This makes everything more complicated for regulations and for facility design and operations and is the precise type of scenario that CRB’s process architects are trained to develop solutions for. CRB is unique in that it has a full team of process architects on its staff. The early involvement of process architects helps companies properly plan the facility for scaling out and future proof design strategies. Accounting for these scenarios early in the design process for cell and gene therapy production facilities can save the company from expensive challenges later on.
CRB is an industry leader in integrated project delivery methodology for facility design and construction. In a field where time and money matter in order to bring new therapies to patients cheaper and faster, CRB is becoming a partner of choice for many cell and gene therapy companies in the BHCR and across the globe.
CRB’s successful delivery of its part of the new Paragon Bioservices facility helped create one of the assets acquired by Catalent via its $1.2B acquisition of Paragon in April 2019.
The ripple effect of CRB’s successful project delivery contributed to a manufacturing deal between Catalent and AveXis, a Novartis Company. AveXis will now use the former new cGMP Bioservices facility as an additional manufacturing site for its blockbuster spinal muscular atrophy (SMA) gene therapy, ZOLGENSMA®.
CRB has also made significant contributions beyond cell and gene therapy, adding to the strength of the BHCR cluster. In 2018, CRB partnered with Emergent Biosolutions to build a state-of-the-art manufacturing facility in Baltimore, Maryland. The facility won a 2018 ISPE (FOYA) Honorable Mention Award. Emergent’s Center for Innovation in Advanced Development and Manufacturing (CIADM) is one of only three in the U.S. and is part of a multi-year public-private partnership (P3) between Emergent Biosolutions and the Biomedical Advanced Research and Development Authority (BARDA).
Company funding announcements, licensing agreements, IND submissions, FDA approvals and IPOs are all newsworthy, important milestones both for individual companies and the entire region. However, without the contributions of experienced, skilled, and collaborative professional service providers like CRB and others, bringing new technologies and therapies to the market would be slower and more expensive, or might not occur at all.
It takes a village to deliver innovative new medicines to patients in need and to grow a world-class biohealth cluster like the BHCR. CRB is an important part of this village and an integral component of advancing bioscience manufacturing and commercialization in Maryland and all across the globe.