From analytical development to drug substance and drug product process development and scale-up, we can help advance your clinical candidate to its next key milestone and beyond. Take a look inside our Center of Excellence for Development Services at our Gaithersburg, MD facility to learn more.

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! 

There has been a steady increase in demand for lyophilized products in recent years. Due in large part to biologic drug innovation and technological advancement in the lyophilization process as well as ease of access to outsourcing partners who specialize in the formulation development and manufacturing of lyophilized biological products. 

In this article, Emergent experts discuss the factors that are driving the demand of lyophilized products and what to consider when selecting a CDMO partner to support your drug manufacturing needs. 

“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 

Our drug product manufacturing facility in Rockville, Maryland is undergoing an expansion that will soon house a state-of-the-art high speed fill/finish line with fully integrated isolator technology and an automated inspection, labeling, and packaging line. Take a look at the time lapse video of our progress so far!

Watch our latest webinar on the topic of aseptic fill/finish and isolator-based technology for pre-sterilized syringes, cartridges, and vials.

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).

In a recent Pharmaceutical Technology article, Emergent experts provide their insights on selection of technologies for vaccine development. 

Read the full article here. 

Emergent has entered into a new CDMO agreement with Providence Therapeutics to provide fill/finish drug product manufacturing services for their investigational mRNA vaccine candidate (PTX-COVID19-B) at its facility in Winnipeg, Manitoba, Canada. This is Emergent's 8th COVID-19 CDMO collaboration, and first outside of the U.S. in Canada.

GAITHERSBURG, MD. and BURLINGAME, CA. – Jan. 25, 2021 — Emergent BioSolutions Inc. (NYSE:EBS) (Emergent) and Humanigen, Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have entered into a contract development and manufacturing (CDMO) services agreement to accelerate the drug product manufacturing of lenzilumab™, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called “cytokine storm.” Emergent will provide access to manufacturing capacity reserved for and provided by the U.S. government under Humanigen’s Cooperative Research and Development Agreement (CRADA) with the Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization (EUA) in the first quarter of 2021.

Introducing Emergent’s new interactive CDMO booth display! Take a tour of our virtual booth to browse videos, download brochures and connect with our team to explore how we can support your next clinical or commercial project. 

Excerpt taken from BioPharm International October 2020 Regulatory Sourcebook article titled: GMPs Guide COVID-19 Vaccine Manufacturing.

“The FDA Guidance highlights the pertinent CGMP [current good manufacturing practice] considerations for all vaccine manufacturing and serves as a reminder of statutory GMP expectations for COVID-19 vaccines specifically,” says Karolyn Gale, senior director, regulatory affairs, Emergent BioSolutions."

View the full article here.

Jee Look, senior director of drug product development for Emergent BioSolutions recently contributed to an article in Pharmaceutical Technology titled, "Factoring Stability in the Biological Drug Mix."

Stability issues can also occur at any stage of a vaccine’s development lifecycle, according to Jee Look, senior director of drug product development for Emergent BioSolutions’ contract development and manufacturing organization (CDMO) business. “In some cases, instability that occurs during upstream/downstream processing can be mitigated during final drug product manufacturing, but it is important to identify and understand the mechanisms of instability early in the pre-formulation stage as instability in the final drug product would have the largest impact on patient safety and overall production efficiency and would be more costly to fix,” he says.

With ongoing advances in science and technology, the cell and gene therapy pipeline has grown especially robust over the past few years. At present, Clinical Trials.gov shows more than 4,500 active gene therapy trials globally. In the United States, McKinsey experts expect to see 10 to 20 cell and gene therapy approvals per year over the next five years. 

This article discusses the important factors to consider when selecting an outsourcing partner for your advanced therapies. 

Emergent BioSolutions, a Wells Fargo Corporate & Investment Banking customer since 2011, helps governments respond to health emergencies before they happen. Eight years ago, they were planning for a crisis like Covid-19. America will need hundreds of millions of doses of a vaccine. Emergent is manufacturing them now, before they've been approved for use, so they'll be ready if they measure up. 

Syed T. Husain, senior vice president and CDMO business unit head at Emergent BioSolutions recently contributed to an editorial titled, "Strategizing for Rapid Changeovers in Biologics Manufacturing" in the September issue of BioPharm International. 

Read the full article here. 

“Emergent has a long, successful history of working with the US government to develop, manufacture, and deliver safe and effective medical countermeasures for public health. BARDA has been an excellent partner, across all levels from leadership to the project and technical teams with whom we work closely. As partners on a team, we work collaboratively to monitor, evaluate, and progress projects and help remove barriers that slow down the directive of Operation Warp Speed.”

Dino Muzzin, senior vice president of manufacturing operations at Emergent BioSolutions contributed to an editorial in the August issue of Pharmaceutical Technology on the pivotal role outsourcing partners are having in the rapid development and production of COVID-19 vaccine candidates. 

Read the full article here. 

Dino Muzzin, senior vice president of manufacturing operations at Emergent BioSolutions recently contributed to an editorial in Pharmtech.com discussing the importance of collaboration between innovators, manufacturing partners, and the entire supply chain when preparing for rapid scale-up of COVID-19 vaccine candidates. 

In a recent article with BioProcess International, Syed T. Husain, senior vice president & CDMO business unit head at Emergent BioSolutions, discusses the critical role Emergent has in supporting the development & manufacturing of COVID-19 vaccine candidates. 

• Emergent will provide contract development and manufacturing services beginning in 2020 to produce drug substance at large scale for commercial supply
• Agreement is valued at approximately $174 million through 2021 and brings the total AstraZeneca commitment to $261 million
• Parties may enter into additional commercial manufacturing commitments as the candidate progresses over three years through Emergent’s flexible capacity deployment model

GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.

Emergent will be participating in the Disease Prevention & Control Summit taking place virtually, July 28 - 29, 2020. 

Dates: July 28 - 29, 2020 

Location: Virtual Conference

Register for free here. 

Read the latest news coverage of Emergent's insights and involvement in the fight against COVID-19.
Last Updated: Thursday, November 12, 2020

Missed our presentation at the BioProcess International Theater during BIO Digital? BPI is hosting an encore event on July 8 & 9 with access to more than 30 scientific presentations, executive interviews, and panel discussions focusing on emerging therapies and technologies.

Register for free to listen to Emergent's on demand presentation: Solutions for Rapid Development and Manufacturing Responses to COVID-19 and Other Public Health Threats.

When: July 8, 2020 at 2:15 PM ET
Where: OnDemand
Presenter: Richard W. Welch, PhD, Vice President, Development Services at Emergent BioSolutions

Dino Muzzin, Senior Vice President, Manufacturing Operations at Emergent, recently contributed to an article in BioPharm International titled, Good Manufacturing Practices: Challenges with Compliance.

In this article, Muzzin and other industry experts discuss obstacles, best practices for compliance, and where further guidance may be needed to fill the gaps in GMPs.

• Emergent will provide contract development and manufacturing services and secure large-scale manufacturing capacity through 2020 to support AstraZeneca’s COVID-19 vaccine candidate
• Agreement valued at approximately $87 million

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced it will deploy its molecule-to-market contract development and manufacturing (CDMO) services to support the manufacturing of AstraZeneca’s vaccine candidate for COVID-19, AZD1222, a viral vector-based, weakened version of adenovirus containing the genetic material of SARS-CoV-2 spike protein, developed by Oxford University’s Jenner institute working with the Oxford Vaccine Group.

Topic: Solutions for Rapid Development and Manufacturing Responses to COVID-19 and Other Public Health Threats

Speaker: Richard W. Welch, Ph.D., Vice President Development Services, Emergent BioSolutions

Date: OnDemand Presentation

Emergent BioSolutions will be participating in Bio Digital the week of June 8 - 12. 

Wherever you are in your journey, Emergent offers solutions from a respected CDMO with extensive experience working with governments, regulatory agencies, and biopharma companies of all sizes.

Emergent BioSolutions recently announced that it has been issued a task order under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), to deploy its contract development and manufacturing (CDMO) capacities, capabilities, and expertise to support the U.S. government’s efforts to accelerate delivery of COVID-19 vaccines.

• Emergent and HHS expand 2012 CIADM public-private partnership with task order valued at approximately $628 million for rapid domestic production of leading COVID-19 vaccine candidates through 2021  
• Emergent will provide molecule-to-market CDMO services and commit manufacturing capacity, valued at approximately $542.7 million, paving the way for pharmaceutical and biotechnology innovators to advance COVID-19 programs
• Task order also includes approximately $85.5 million for expansion of Emergent’s viral and non-viral CDMO drug product fill/finish capacity

GAITHERSBURG, Md., June 01, 2020 (GLOBE NEWSWIRE)  - Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has been issued a task order under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), to deploy its contract development and manufacturing (CDMO) capacities, capabilities, and expertise to support the U.S. government’s efforts to accelerate delivery of COVID-19 vaccines.

Watch our latest webinar on the topic of how drug developers can maximize capacity, capabilities and expertise for pandemic response. This presentation is Part 2 in a Coronavirus Virtual Series brought to you by FiercePharma with featured speaker Sean Kirk, EVP Manufacturing & Technical Operations.

GAITHERSBURG, Md., April 23, 2020 (GLOBE NEWSWIRE)

Emergent BioSolutions Inc. (NYSE:EBS) today announced an agreement whereby Emergent will deploy its contract development and manufacturing (CDMO) services to support the manufacturing of Johnson & Johnson’s lead vaccine candidate for COVID-19 that leverages the AdVac® and PER.C6® technologies from the Janssen Pharmaceutical Companies of Johnson & Johnson.

What are innovators doing to speed up the path to treating and preventing COVID-19?

The novel coronavirus has quickly taken over many aspects of the daily lives of people around the globe, stressing the healthcare system and putting

scientists at the forefront of this pandemic. Explore this new topic with Dr. Richard Welch, as he discusses how companies are mounting a rapid and effective response to the current challenges of the latest public health threats.

• CDMO agreement for NanoFlu to support pathway to licensure
• Expanded collaboration now includes NanoFlu and COVID-19 vaccine candidate

GAITHERSBURG, Md., March 31, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced an agreement with Novavax, Inc. (NASDAQ:NVAX) whereby Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older.

Original news coverage of Novavax's agreement with Emergent BioSolutions to manufacture and develop an experimental oral vaccine candidate for the Coronavirus Disease.

Original news coverage of Vaxart's agreement with Emergent BioSolutions to manufacture and develop an experimental oral vaccine candidate for the Coronavirus Disease.

GAITHERSBURG, Md., March 18, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.

GAITHERSBURG, Md., March 10, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Novavax, Inc. (NASDAQ:NVAX) whereby Emergent will collaborate with Novavax, utilizing its molecule-to-market contract development and manufacturing (CDMO) services to support bringing into the clinic Novavax’s novel experimental vaccine candidate to protect against coronavirus disease (COVID-19). Under the terms of the agreement, Emergent will produce the COVID-19 experimental vaccine candidate, which is based on the proprietary recombinant protein nanoparticle technology platform of Novavax and utilizing their proprietary Matrix-M™ adjuvant to enhance immune responses. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase 1 clinical study within the next four months.

Following up on the recent article Two Maryland Biotechs Partner to Bring Coronavirus/COVID-19 Vaccine Candidate into Clinical Trials, BioBuzz had the opportunity to speak with Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk.