Regardless of where a drug candidate is in the development pipeline, performing a technology transfer (tech transfer) presents unique challenges for the partners involved.

Overcoming these challenges is critical to ensuring the ultimate success of the product when working with a Contract Development and Manufacturing Organization (CDMO). There are a myriad of ways in which a tech transfer can fail to meet its potential – unsatisfactory yields, unforeseen materials shortages, unoptimized batch sizes that can impact the quality and timelines of the transferred product.

• Total baseline value for Emergent is approximately $90 million USD, further expanding the collaboration between the companies, which began in February 2021

GAITHERSBURG, Md. and CALGARY, Alberta, Sept. 14, 2021 (GLOBE NEWSWIRE)-- Emergent BioSolutions Inc. (NYSE:EBS) and Providence Therapeutics today announced they have entered into a five-year contract development and manufacturing (CDMO) services agreement spanning Emergent’s integrated capabilities, including development services, bulk drug substance formulation and drug product manufacturing, to support Providence’s COVID-19 messenger RNA (mRNA) vaccine development. In 2022, Emergent will manufacture tens of millions of doses of PTX-COVID19-B drug product, as well as batches of PTX-COVID19-B formulated bulk drug substance with the potential to yield hundreds of millions more doses, for global populations in need of pandemic relief.

Successful downstream processing provides isolation of the molecule of interest from extraneous constituents before formulation, allowing for favorable processing of the desired therapeutic or vaccine.

CDMOs that have the expertise and experience in optimizing downstream purification, filtration, and viral clearance processes for diverse and complex molecules can help their clients achieve positive processing outcomes.

Download our white paper to learn more about downstream processing methodologies and techniques, and how Emergent CDMO's vast expertise and experience can help you achieve your drug substance program goals.

Mitigating risk is a key consideration for biopharmaceutical companies when planning their clinical trial material and/or drug product manufacturing processes. One of the most prevalent sources is material handling: every step in the drug substance or drug product manufacturing process can introduce risk.

Biopharma innovators and contract development and manufacturing organizations (CDMOs) collaborate to ensure a number of technologies are utilized to safeguard the integrity of these products. One method is to leverage a Restricted Access Barrier System (RABS) or isolator technology during drug product manufacturing.

Download our white paper to learn more about RABS and isolator technologies, similarities, differences, and benefits, and how Emergent CDMO's vast expertise and experience can help support your drug product manufacturing and packaging needs.

With the expansion of our viral drug product manufacturing facility in Rockville, Maryland well underway, we have begun outfitting our new viral manufacturing suites. The Groninger® INTEGRA, a state-of-the-art high speed fill/finish line with fully integrated isolator technology and automated inspection, labeling, and packaging, recently made it's journey from Germany to the US. The INTEGRA is an integral part of our strategic plan to continue supporting our clients in the fight against the COVID-19 pandemic and other life-threatening viral diseases. Since arriving at our facility, the Emergent team has been working diligently to complete installation and qualification of the new line and progress continues. 

Check out a few photos of the INTEGRA being shipped to Emergent! 

“The Vanrx SA25 Aseptic Filling Workcell is a state-of-the-art machine, providing our clients with a high level of sterility assurance and flexibility through an automated handling, filling, and closing process, designed to minimize line losses. If you have a high-value product and require a small-to-moderate batch size, the Vanrx may be the ideal fit for your program.”

- Kevin Gadient
Director, Manufacturing Sciences & Technology 

EMERGENT BIOSOLUTIONS ON TRACK WITH RESPECT TO COVID-19 CONTRACTUAL COMMITMENTS; RECEIVES MODIFIED TASK ORDER FROM THE U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES TO SUPPORT THE OPPORTUNITY FOR FURTHER EXPANSION OF MANUFACTURING CAPACITY FOR JOHNSON & JOHNSON’S COVID-19 VACCINE

• HHS has increased Emergent’s task order by $23 million to purchase additional biologics manufacturing equipment
• Reaffirms 2021 financial guidance

GAITHERSBURG, Md., April 04, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the Company continues to be on track with its manufacturing agreements related to COVID-19 vaccines and confirmed that there are no changes to its financial guidance for 2021. In addition, the Company received a contract modification to increase the original task order by $23 million from Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS).