Baltimore Biotech Earns International Recognition for Advanced Development and Manufacturing Facility

Located in Eastern Baltimore, just off of I-95 is Emergent BioSolutions’ Center for Innovation in Advanced Development and Manufacturing (CIADM) facility, which recently won a 2018 Facility of the Year Awards (FOYA) honorable mention. Emergent’s CIADM, one of only three in the U.S., is a result of a multi-year public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA).

FOYA is an awards program sponsored by the International Society of Pharmaceutical Engineering (ISPE) that seeks to “…recognize projects that demonstrate cutting-edge engineering, innovative new technology, and advanced applications of existing technology.”

2018 FOYA winners included only seven facilities selected from scores of applicants from across the globe.

“We’re very proud to have been selected. The full significance of this award dawned on us during the banquet when we heard from other winners about the impact they were having on patients. We are fortunate to be thought of in the same company as the other award winners,” stated CIADM site head and VP and general manager, Scott Battist.

Emergent gave credit to a number of its expansion project partners for winning the 2018 FOYA honorable mention. “CRB Engineers did amazing work with us on modeling and value engineering. They were instrumental in helping our team during the project and throughout the application process. They were a great partner along with all of our tremendous construction trades and project management partners, in addition to sponsoring partner, BARDA,” added Battist.

FOYA recognized CIADM for its remarkable flexibility, scalability and manufacturing control capabilities.

The facility is capable of multi-platform,multi-process and multi-scale production using cross-functional manufacturing suites that can produce cell culture, microbial and viral hosts. Equipment and technological platforms can be added or removed efficiently to accommodate various processes, including the emergency production of pandemic flu vaccine as well as products from Emergent’s own pipeline. These flexible,multi-function platforms and processes are then rolled up into a state-of-the-art facility control system anchored by data historian OSIPI

“We wanted to build a facility that could perform a wide range of manufacturing processes. We have the equipment and platforms needed to respond quickly to a wide array of possible scenarios… the real challenge is doing viral and non-viral products in the same facility, and the CIADM is designed with this unique capability,” stated Battist.

Brad Sepp, CIADM’s director of MS&T, added, “A lot of thought was put into the conceptual planning required for such a complex, flexible facility. The different scales and possible problems to solve across products presents various quality assurance and regulatory challenges.”

“’Islands of automation’ was our strategy from the beginning because the majority of single-use solutions came as packaged units. We leveraged Factory Talk to roll up all individual pieces into a common process control system backed by a central data historian, OSI PI.  ACC was a great partner on developing our architecture,” he continued.    

The company’s 20-year track record as a leading provider of preparedness solutions to the U.S government laid the groundwork for its selection as a BARDA partner in this unique public-private partnership to build and operate the 56,000 square foot expansion capable of rapidly responding to significant public health threats, including pandemic flu outbreaks.

“The building design and CIADM concept were born out of the 2009 H1N1 scare. Back then, the government assessed the nation’s capabilities of dealing with a pandemic and the requirements to generate massive doses of vaccines within a short period of time to inoculate the public if such an emergency arose. This led to the funding of three BARDAfacilities and the platform technologies designed to produce necessary medical countermeasures when a public health emergency is declared,” stated Battist.

Emergent’s CIADM plays a significant role in national biodefense efforts. Should a flu pandemic be declared the facility can produce 50 million flu vaccine doses within four months, putting it on the front lines of national security and public health preparedness.

The Baltimore facility has come a long way since 2009 when it was purchased by Emergent and was operated by a staff of only five. Since then, the site has doubled in size to 112,000 square feet and, as the facility approaches its 10th anniversary, it employs approximately 90 staff with additional hiring projected to raise that number to about 126 by the close of 2019.

“It’s been progress, for sure,” said Sepp. “As the facility has grown, so have our staffing needs for multi-talented, highly educated, versatile team members that can operate in a highly complex manufacturing environment. This progress has been good for us and the city of Baltimore as well as the State of Maryland as a whole, and we look forward to continued growth in the region.”

“There’s a strong push at Emergent and at our site for innovation and next generation technologies. We have a progressive approach to our government partnerships so we’re in lock step with the changing times. We envision that our facility could be a prototype for future manufacturing facilities as the industry transitions to evolving approaches,” stated Sepp. 

ISPE’s facility of the year awards honorable mention represents a significant achievement for Emergent and its CIADM team, shining a well-deserved spotlight on the organization’s commitment to innovation in the interest of improving patient outcomes and public health threat readiness.

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Emergent BioSolutions

Emergent BioSolutions is a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, USA. It develops vaccines and antibody therapeutics for infectious diseases, oncology and autoimmune disorders, and provides medical devices for biodefense purposes