Why Advanced Biomanufacturing in Maryland is a Thriving Industry

These Four Industry-leading BioManufacturing Companies Represent Thousands of Jobs in Maryland and Are Shaping the Future of Medicine

A burgeoning cell and gene therapy sector coupled with a world-leading vaccine industry has the Maryland life science hub brimming with biomanufacturing activity and innovation. 

Advanced biomanufacturing is booming in Maryland.

According to the Maryland Department of Commerce, approximately 500 biotech companies call Maryland home, creating thousands of high paying biomanufacturing jobs all across Maryland. The U.S. Food & Drug Administration (FDA), the National Institutes of Health (NIH), and many other government research entities are also located in Maryland, complementing a robust university research system anchored by Johns Hopkins University (JHU) and the University of Maryland system (UMD). State-supported innovation and investment programs like TEDCO’s Maryland Innovation Initiative (MII) which funds novel university technologies to support tech transfer and commercialization, and the Maryland Stem Cell Research Fund (MSCRF) which has directly helped to fuel the growth of Marylands Stem Cell industry through grants for research through commercialization.

With a rich history in vaccine development and biodefense, the state already had a robust biomanufacturing infrastructure and talented workforce in place before it became a global leader in stem cell production and a growing hub for personalized medicine advanced biomanufacturing, attracting companies such as Kite, a Gilead Company, Autolus and Catalent Gene Therapy who all recently expanded into Maryland to build and grow their advanced biomanufacturing operations.

What’s more, the race for a safe and effective SARS-CoV-2 vaccine, and the need to be able to produce an approved vaccine rapidly and in great quantities, has sent the state’s biomanufacturing sector into overdrive on the shoulders of companies such as Emergent BioSolutions, Novavax, AstraZeneca and Altimmune. There is a perfect advanced biomanufacturing storm brewing in Maryland, and within the broader BioHealth Capital Region, which also includes Virginia and Washington, D.C, and it’s bringing a flood of biomanufacturing jobs along with it.

Check out the top BioManufacturing Jobs In Maryland

According to the Biomedical Engineering Society (BES), advanced biomanufacturing “…is an emerging field in biomedical engineering. It focuses on studying theories and technologies of manufacturing bio-related products, including natural or synthetic biomaterials, cells, and cell-based therapeutic products such as individualized tissues and organoids, devices with biomaterials, and/or cells as components. Unlike conventional biomanufacturing, advanced biomanufacturing builds on the groundbreaking discoveries such as 3D additive manufacturing, genome editing, cell reprogramming, and transdifferentiation, systems and synthetic biology, stem cell biology, computational modeling, micro and nanofabrication, material genomes, biomaterials, tissue engineering, and regenerative medicine.”

In other words, advanced biomanufacturing is the tip of the spear when it comes to producing innovative, life-changing, and life-saving therapies right now and into the foreseeable future.     

Of all of Maryland’s ample life science assets, advanced biomanufacturing might hold the key for the BioHealth Capital Region to achieve its collective goal of becoming a top three ranked Genetic Engineering and Biotechnology News (GEN) biotech hub by 2023.

In addition to regional anchor life science companies like AstraZeneca (AZ), GlaxoSmithKline (GSK) and Thermo Fisher Scientific, four Maryland companies are leading the charge in expanding the state’s advanced biomanufacturing footprint: Kite, a Gilead Company; Emergent Biosolutions; Catalent; and RoosterBio, Inc.

Kite, a Gilead Company

Kite was acquired by Gilead Life Sciences for $11.9B in late August 2017. By October  2019, the FDA approved Kite’s CAR-T cancer therapy, YESCARTAⓇ, making it one of the first autologous cell therapies ever approved by the FDA for cancer. Just recently, the FDA approved Kite’s Tecartus™ as the First and only CAR T treatment for Relapsed or Refractory Mantle Cell Lymphoma.  This made Kite the first and only company with multiple approve CAR T cell therapies.

The success of YESCARTA has sparked more than 100% growth at Kite over the past two years. In 2018 Kite opened a Gaithersburg, Maryland site to support a National Cancer Institute (NCI) Cooperative Research and Development Agreement (CRADA) and advance the development of adoptive cell therapies targeting patient-specific tumor neoantigens.

In April 2019, the company announced plans to open a new biologics manufacturing facility in Frederick County, Maryland, that will produce innovative cell therapies for people with cancer. The new, leading-edge advanced manufacturing facility is scaling up its hiring and is set to open in 2021.

“This new facility in Urbana builds on our substantial technical capabilities and rapid progress in making personalized chimeric antigen receptor T and T cell receptor cell therapies for people with cancer,” said Tim Moore, Executive Vice President of Technical Operations at Kite. “As we advance our industry-leading cell therapy pipeline and seek to help a growing number of people with cancer, expanding and investing in our manufacturing capabilities is essential. With the Urbana site, we will have the opportunity to build and design the facility tailored to our own innovative processes and with state-of-the-art features that will enable us to meet the future needs for cell therapies.”

The new facility will be approximately 280,000 square feet and will produce YESCARTA and other prospective CAR-T oncology therapies. The personalized nature of CAR-T production where a single batch is matched to a single patient necessitates agile, skillful, and highly technical manufacturing processes, deploying some of the most complex manufacturing techniques that require advanced automation.

The end-to-end automated capabilities at Kite’s new facility will help speed up production and manage what can be a complicated and costly manufacturing process. Limiting manual processes and single-use materials are critical to the successful manufacture of these highly sensitive, personalized medicines. CAR-T manufacturing is part of a personalized medicine process that genetically codes a single patient’s T-cells. Blood gets drawn and shipped to the manufacturing site where the Kite facility will manufacture the patient-specific therapy; the therapy is then shipped back to the patient for infusion. This all has to happen very quickly and efficiently to be effective.

Gilead/Kite’s new facility, set to open in 2021, will become one of Maryland’s advanced biomanufacturing jewels for years to come.

Emergent Biosolutions

Emergent Biosolutions is a rapid response Biodefense and Contract Development and Manufacturing Organization (CDMO). In 2017, the company opened a new advanced biomanufacturing facility in Baltimore, Maryland through a multi-year public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA).

The company’s Advanced Development and Manufacturing (CIADM) facility recently won a 2018 Facility of the Year Awards (FOYA) honorable mention. Emergent’s CIADM is one of only three such facilities in the U.S. The original facility, which was purchased by Emergent in 2007 and housed only five staff, was expanded to a total of 112,000 square feet (56,000 square feet of new, expanded space) and reengineered with some of the most advanced manufacturing capabilities available. 

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 OSI PI.

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, putting it on the front lines of national security and public health preparedness.

The CIADMfacility was designed with the capability to rapidly scale up and produce 50 million flu vaccine doses within four months,

With the arrival of COVID-19, Emergent Biosolutions was poised to execute on CIADM’s mission and leverage their CDMO expertise to fight the pandemic. Emergent BioSolutions has signed on several large COVID-19-related contracts and partnerships since the discovery of COVID-19, including the expansion of the HHS public-private CIADM partnership with the Operation Warp Speed task order valued at approximately $628 million for rapid domestic production of leading COVID-19 vaccine candidates through 2021   As a result, Emergent holds a top spot on USA Today’s list of companies receiving the largest COVID-19 government contracts.

Here is a list of Emergent’s COVID-19 programs.

• In mid-June, the company announced a manufacturing partnership with AstraZeneca to produce its COVID-19 vaccine candidate, valued at approximately $87M.
• In late April of this year, Emergent BioSolutions announced a partnership with Johnson & Johnson (J&J) to provide contract development and manufacturing services to support J&J’s COVD-19 vaccine efforts, valued at more than $480M.
• Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers formed a Collaboration to Develop Emergent’s COVID-19 Hyperimmune Globulin (COVID-HIG) Product Candidate with U.S. Department of Defense Funding
• Emergent BioSolutions Signs Development and Manufacturing Agreement with Vaxart for their Experimental Oral Vaccine Candidate for Coronavirus Disease
• Emergent BioSolutions Signs Development and Manufacturing Agreement With Novavax for their Experimental Vaccine Candidate for Coronavirus Disease, in addition to a separate agreement to manufacture Novavax’s NanoFlu™.

Emergent has been growing exponentially and adding hundreds of biomanufacturing jobs, ensuring they will remain a powerful force within the region’s advanced biomanufacturing ecosystem.

Catalent, Gene Therapy

Another CDMO with a presence in Maryland, Catalent Gene Therapy is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. Catalent employs approximately 11,000 staff that supports some 7,000 products, including personalized medicine therapies that require advanced biomanufacturing capabilities.

To support the company’s growing personalized medicine clientele and meet the demands of the booming gene therapy industry, the company acquired Maryland’s Paragon Bioservices in 2019 for $1.2B.  This blockbuster deal closed just a few weeks before Paragon officially opened a brand new, 150,000 square foot, state-of-the-art, world class gene therapy manufacturing facility in Anne Arundel County, Maryland. Paragon BioServices was a home-grown Maryland biotech company that started in a Baltimore incubator 30 years ago, and had grown to more than 400 employees prior to the acquisition.

The former Paragon BioServices was a CDMO that caught the attention of Catalent with their unparalleled expertise in gene therapy manufacturing for clinical and commercial therapeutics. At the time Paragon was acquired, it had projects underway with 20 of the world’s top 40 gene therapy developers, which made them an ideal acquisition target for Catalent.

According to Catalent’s press release about the acquisition, their new advanced gene therapy facility “…is equipped with several 500-liter and 2,000-liter single-use bioreactors for clinical through commercial material production. The new large-scale production campus – now combined with a recently leased second building which will be built out for commercial GMP manufacturing – has the potential for more than 425,000 square feet of biomanufacturing space upon completion.”

Catalent has been actively expanding its capabilities and their gene therapy client portfolio and has been hiring for hundreds of biomanufacturing jobs in Maryland to support its growth. Additionally, in June 2019, Catalent Gene Therapy struck a deal with Novavax to acquire two leases for product development and manufacturing facilities in Gaithersburg, Maryland. Catelent also added 100 highly-skilled biomanufacturing staff as part of the deal. The deal not only significantly added to Catalent’s advanced biomanufacturing footprint in Maryland, but it also was a critical move for Novavax that had been struggling but has since made a remarkable comeback since pivoting to developing its own COVID-19 vaccine candidate.

CatalentGene Therapy has added several new client partnerships this year, including several COVID-19 manufacturing partnerships with Humanigen, Moderna, and AstraZeneca.

RoosterBio, Inc.

RoosterBio, located in Frederick, Maryland, is a stem cell manufacturing company that works side-by-side with regenerative medicine product developers, tissue engineers, cell therapists, and synthetic biologists to advance research and therapies across the globe.

RoosterBio started with five staff members during its days in the Frederick Innovative Technology Center (FITCI) incubator. Fast forward a few years, and RoosterBio is at the cutting-edge of supporting advanced biomanufacturing processes critical to personalized medicine development. RoosterBio  develops standardized stem cell products that are ‘ready to use’ or ‘plug and play.“ RoosterBio’s stem cell products simplify the process of incorporating living cells into a new medical product that is being developed.

According to RoosterBio’s Founder and Chief Product Officer Jon Rowley, RoosterBio is “…working on making it 10 times easier and 10 times less expensive, truly democratizing stem cell technology.” The company is manufacturing stem cell products like components, similar to the way parts are purchased for computers and other technologies. RoosterBio is one of only a handful of companies in the United States selling clinical-grade stem cell banks for use in clinical trials.

According to Taby Ahsan, PhD, Vice President of Development in a 2019 GEN Engineering News Article that highlighted RoosterBio’s “next-gen” MSC bioprocessing strategies; “Expanding cells on microcarriers in a scalable suspension bioreactor system, we routinely now generate 25–30 billion cells in a single development run. This same system can currently be directly scaled by at least 10–20-fold,” she discloses. “Meanwhile, we are continuing to optimize our processes to further improve our cell expansion rates and yields for consistent production for the GMP arena and clinical uses.”

RoosterBio’s cGMP stem cell products are manufactured in a cGMP pharmaceutical manufacturing facility under stringent production controls. With the explosion in personalized medicine research and development, companies like RoosterBio will play a critical role in streamlining advanced manufacturing processes by automating and simplifying the production of critical stem cell products for use in the personalized medicine manufacturing process.

RoosterBio began 2020 with plans to add an additional 5,000 square feet of space to its 15,500 sq/ft Maryland cGMP manufacturing facility. The move was to position the company to expand its global cell manufacturing solution portfolio throughout the Asia Pacific and European markets. This marks the second expansion in the past year which has also reflected in a 30% growth in employees over the past 12 months and the addition of many new stem cell biomanufacturing jobs.

The success and growth of organizations like Kite, a Gilead Company, Emergent Biosolutions, Catalent and RoosterBio are clear signs that Maryland and the BioHealth Capital Region are at the forefront of advanced manufacturing and will be a leading hub for the production of revolutionary gene and cell therapy products that are reimagining the way we think about medicine and treat patients.