Gene therapies push AAV vector production

Several virus types have been studied for use as viral vectors in gene therapy, including adenovirus, lentivirus, retrovirus, and adeno-associated virus (AAV). All platforms have their own advantages over one of the others. The recent successes with AAV and lentivirus give these vectors a boost in development. In combination with the fact that they are well studied, might make them the frontrunner for some therapeutic applications. Our Technical Lead, Kai Touw, has been interviewed by BioPharm International to discuss the potential and challenges of viral vector production for gene therapy.

Link to full article.

New Head of BD: Ron van Eijsden

With Ron van Eijsden heading the Sales and Business Development team, Batavia expands its Management Team and reinforces its sales activities to support the ambitious expansion plans.

In 2021, Batavia successfully doubled its viral vector process development capacities in Woburn, MA, USA. This year, Batavia will double its infrastructure in Leiden, the Netherlands, to support the growing demand for process development and analytical capabilities in pursuit of viral vaccines and viral vector-based products. As part of its ambition, Batavia also started preparations to build a clinical and commercial manufacturing facility in Leiden, to support its clients. With these expansions, Batavia will offer end-to-end development and manufacturing support to its customers thus living up to its vision in helping to reduce human suffering from infectious diseases and cancer.

Ron van Eijsden commented: “I am excited to be part of the Center of Excellence CDMO Batavia and working to improve the affordability and availability of innovative and life-saving biopharmaceuticals. We work for some of the most exciting biopharma companies, academia, charity organizations and governmental organizations at the forefront of biopharmaceutical development. In my role as head of Business Development I can seamlessly combine my passion for networking and business development whilst making an impact on Global Health and bringing medicines to patients faster. I like that, at Batavia, it is not only about executing what our customers ask for, but about being a thought partner in designing the most optimal development roadmap”.

Ron has a PhD in molecular biology and an extensive career in business development within the red biotech industry. Prior to joining Batavia, Ron has worked in a variety of senior roles in various biopharmaceutical and biotech companies, including DCPrime, Pepscope, HAL Allergy, Catalyst Clinical Research, Linical Accelovance and Medelis Europe.

Increased Capacity in The Netherlands

Leiden, The Netherlands,  June 14, 2022 – Today, Batavia Biosciences announces the expansion of its headquarters and R&D capacities in the Netherlands. The infrastructure increases capacity with another 22,500 sq. ft., firmly demonstrating the company’s commitment to act as pacemakers within the rapidly growing biopharmaceutical market.

The expansion allows the company to increase its R&D activities for viral vector-based product development including Lentivirus, AAV, Adenovirus, and Measles virus vectors. In addition, the increased R&D infrastructure helps to meet increased global demand for vaccine development, be it live-attenuated, whole killed, vectored, or subunit vaccines. The expansion will be finalized by June 2023.

Menzo Havenga, CEO of Batavia Biosciences, states, “At Batavia, we are reminded daily of the urgency of bringing medicines to patients in need. With this infrastructure expansion, our contribution of award-winning process development and clinical manufacturing of vaccines and vector-based products can continue its ascent to new heights. No doubt this will further enable us getting the necessary medicines and therapies into the patients’ hands faster and make them more affordable.”

Chris Yallop, CSO at Batavia Biosciences, adds, “The new laboratory floor space for R&D and analytical capabilities will aid the development capacity for customer projects. The increased allocation for R&D capacity better positions Batavia Biosciences to serve as pacemakers to the community and to continue to bring promising candidate biopharmaceuticals from bench to clinic.”

ViE Award

Washington, April 20, 2022 – Batavia Biosciences was honored this week during the Vaccine Industry Excellence (ViE) Awards show at the World Vaccine Congress with the award for Best Production/Process Development. The ViE Awards provide a time and place to celebrate the industry’s most outstanding achievements showcasing excellence in the global vaccine industry. Being recognized for the award is affirmation and a testament to the employees incredible work at Batavia. Helping to reduce human suffering and provide affordable and equitable access of vaccines to everyone has been and will continue to be our goal.

Judges at the ViE Awards evaluated Batavia and other shortlisted competitors looking for evidence and examples around 5 major areas:

  • Demonstration of ongoing commitment to provide production technology globally and reducing lead times for its customers
  • Demonstration of end-to-end suite solutions to customers
  • Demonstration of outstanding thought leadership and spearheading innovation
  • Raising the bar on process standards
  • Demonstration of quality of relationships with clients

Batavia was able to provide sound evidence for each category and take home the prestigious award. Batavia is a Center of Excellence CDMO and next to providing high quality services, we provide thought partnership, share best practices, perform research, and provide support.

Menzo Havenga, CEO Batavia Biosciences, says: “I am proud of what we have achieved with Batavia in the past 12 years. This award is a great recognition for our efforts to make vaccine manufacturing more affordable to support accessibility for all in need.”

We would also like to congratulate other shortlisted candidates for the Best Productions/Process Development award; Moderna, LumaCyte, Millipore Sigma, Sartorius Stedim Biotech, BD Medical, Pharmaceutical Systems, and Eppendorf.

Batavia manufactures LASV vaccine candidate for IAVI who today announced the first vaccinations of their Lassa fever vaccine candidate

Batavia Biosciences would like to congratulate  IAVI  on their press release, as today they’ve announced volunteers in Monrovia, Liberia have been vaccinated with IAVI’s novel vaccine candidate against Lassa fever virus (LASV) in a Phase I clinical trial, named IAVI C102, supported by the Coalition for Epidemic Preparedness Innovations (CEPI).

‘LASV causes significant annual outbreaks of an acute viral illness called  Lassa fever, which is endemic in many parts of West Africa. Outbreaks in Guinea, Liberia, Nigeria, Sierra Leone, South Africa, and Togo have resulted in nearly 6,000 suspected cases and more than 180 deaths since early 2022, according to  reports  by the World Health Organization (WHO).’

IAVI’s LASV vaccine candidate was manufactured by  Batavia  in Leiden, The Netherlands.  As a contract-development and manufacturing organization  focused on delivering sustainable, low-cost manufacturing solutions in the field of infectious disease and cancer, we intend to continue to strengthen our partnership with IAVI and continue to develop an end-to-end platform for more flexible, low-cost production of epidemic preparedness vaccines.

Congratulations to everyone involved in helping reduce human suffering from infectious diseases

Link to IAVI Press Release

Collaboration with IAVI on VSV-Vector

Collaboration with IAVI on VSV-Vector

Mutual expertise drives innovations to address supply issues for vaccines for outbreak pathogens

NEW YORK — MARCH 5, 2020 — IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, and Batavia Biosciences, a contract development and manufacturing organization focused on delivering sustainable manufacturing solutions in the field of infectious disease and cancer, today announced their partnership to accelerate the development of vaccines for emerging infectious diseases (EIDs).

By working with Batavia Biosciences to leverage their state-of-the-art manufacturing approach for highly intensified, modular vaccine production, IAVI intends to develop an end-to-end platform for flexible, low-cost production of epidemic preparedness vaccines, including vaccines against a group of viruses that cause hemorrhagic fevers and other emerging viral disease threats. Importantly, collaborating on these vaccines and developing the platform will also enable these two institutions to accelerate the development of a vaccine candidate to address the rapidly growing coronavirus disease (COVID-19) outbreak.

IAVI’s viral hemorrhagic fever vaccine candidates currently in development are to prevent disease caused by Lassa virus, Marburg virus, and Ebola Sudan virus. These agents are high-priority public health threats with high case fatality rates, as well as potential bioterrorism threats. IAVI licensed the vaccine technology underlying these vaccine candidates from the Public Health Agency of Canada (PHAC). The vaccine candidates, named rVSVΔG-LASV-GPC, rVSVΔG-MARV-GP, and rVSVΔG-SUDV-GP, respectively, are based on a recombinant vesicular stomatitis virus (VSV) vector and were developed by scientists at PHAC’s National Microbiology Laboratory. This same platform was used to produce Merck’s highly efficacious1 Ebola Zaire virus vaccine, Ervebo®, recently approved by the European Commission, the U.S. FDA, and regulators in several African countries and prequalified by the World Health Organization. Ervebo® was originally developed by PHAC scientists and advanced through clinical testing and approval by Merck & Co., Inc.

Today’s agreement builds on IAVI’s expertise in VSV vector technology that it has developed through its own VSV HIV vaccine candidate, another program on which IAVI and Batavia have collaborated for some time. Through this HIV vaccine program, IAVI has gained over a decade of experience in the development and production of viral vector vaccines, with a particular recent focus on the VSV vector approach that will be applied to develop the viral hemorrhagic fever candidates described above.

Mark Feinberg, M.D., Ph.D., IAVI president and CEO, said, “We need new partnership models and new, more flexible ways to respond to emerging infectious diseases. While the recent approval of the Ebola Zaire vaccine is a great achievement, we must be prepared for future outbreaks. We need to be creative about how we get there, and partnering with Batavia helps us achieve our shared vision of a suite of VSV-based vaccines and a secure and sustainable manufacturing solution to produce vaccines for emerging infectious diseases.”

Menzo Havenga, Ph.D., Batavia Biosciences president and CEO, said, “We are very excited to partner with IAVI and to provide cost-effective manufacturing solutions to combat disease threats that have plagued humanity far too long such as those posed by viral hemorrhagic diseases.”

The goal is to have a stable and affordable supply of vaccines for outbreak pathogens through flexible manufacturing solutions. Traditional vaccine manufacturing methods are designed for continuous, long-term production of high volumes of individual vaccines, which requires substantial investments in large-scale fixed facilities. This model is not economically practical to produce vaccines that are needed intermittently in relatively small quantities, such as for stockpiles for outbreak pathogens.

To address this challenge, a more sustainable manufacturing approach is required, and Batavia Biosciences is developing state-of-the-art, highly intensified vaccine manufacturing processes that can be applied in small footprint, low-cost, modular manufacturing facilities. Such processes are being developed for rVSVΔG-based vaccines with the goal of establishing a single rVSVΔG platform manufacturing solution. The advantage of such an approach is that it enables a rapid response and delivery of vaccines against new and emerging outbreaks as well as quickly offering surge capacity as needed to respond to larger outbreaks.

IAVI previously announced an award of $37.5M from the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DoD) to support further development of the Marburg vaccine candidate. DTRA works to enable the DoD, the U.S. government, and international partners to counter potential bioterrorism threats. IAVI’s VSV Lassa fever vaccine candidate is supported by CEPI, the Coalition for Epidemic Preparedness Innovations.

Much of the preclinical work on the vaccine candidates is being done by scientists at IAVI’s  Vaccine Design and Development Laboratory  (DDL) in Brooklyn, New York, which is home to IAVI’s VSV vaccine preclinical development. With its facilities and expertise, the DDL conducts the applied research required to advance promising experimental vaccines from the lab to a stage at which they can meet the regulatory agency guidance associated with production of a clinical trial candidate. In addition, critical work to validate the key assays needed to measure immune responses in clinical trials will be done at IAVI’s  Human Immunology Laboratory  at Imperial College London.

IAVI has assembled a group of international experts from leading institutions around the globe to advance these vaccine candidates. In addition to Batavia, these experts include members of the Viral Hemorrhagic Fever Consortium with its decades of experience researching Lassa, Marburg, and Ebola viruses; preclinical investigators working on cutting-edge immunological assays; and experienced clinical trial sites in the U.S. and Africa.

IAVI’s VSV HIV vaccine candidate has been made possible by many supporters, including the Bill & Melinda Gates Foundation, the Danish Ministry of Foreign Affairs, the government of Canada, Irish Department of Foreign Affairs and Trade, the Japanese Ministry of Finance, the Louis & Rachel Rudin Foundation, the Netherlands Ministry of Foreign Affairs, the Norwegian Agency for Development Cooperation, the Starr Foundation, the U.K Department for International Development, the U.S. National Institutes of Health (NIH), and the World Bank, and through the generous support of the American people from the United States Agency for International Development (USAID).


About IAVI

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV, tuberculosis, and emerging infectious diseases. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at  iavi.org.

About Batavia Biosciences

Batavia Biosciences significantly contributes to ease human suffering from infectious diseases and cancer by improving the success rate in the translation of candidate medicines from discovery to the clinic. We offer our novel technologies and in-depth know-how in order to help our partners to complete preclinical phases in biopharmaceutical product development at higher speed, reduced costs, and increased success. The company focuses on the early stages of product development including cell line generation, upstream process development, purification development, product characterization, and clinical manufacturing. Headquartered in Leiden, the Netherlands, with a subsidiary in Woburn, Massachusetts, and offices in Hong Kong, Batavia Biosciences is privileged to have strong strategic partners worldwide. For more information visit the  website.

About the Public Health Agency of Canada

The Public Health Agency of Canada empowers Canadians to improve their health. In partnership with others, its activities focus on preventing disease and injuries, promoting good physical and mental health, and providing information to support informed decision making. It values scientific excellence and provides national leadership in response to public health threats. We are a federal institution that is part of the Health portfolio.

About IAVI’s Partners in the Ebola Sudan and Marburg Vaccine Development Program

IAVI’s research partners in this vaccine program are investigators at the Center for Global Infectious Disease Research; La Jolla Institute for Immunology; Ragon Institute of MIT, MGH, and Harvard; Tulane University; and University of Texas Medical Branch. The manufacturing partner is Batavia Biosciences. Clinical research partners in the U.S. and Africa are George Washington University, KAVI-Institute of Clinical Research (Kenya), Kenema Government Hospital (Sierra Leone), MRC/UVRI and LSHTM Uganda Research Unit, National Public Health Institute of Liberia, and Center for Family Health Research/Projet San Francisco (Rwanda). Merck & Co., Inc., is a scientific advisor.

1Henao-Restrepo AM, Camacho A, Longini IM, Watson CH, Edmunds WJ, Egger M, Carroll MW, Dean NE, Diatta I, Doumbia M, Draguez B. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!). Lancet. 2017 Feb 4;389(10068):505-18.

Low-cost viral vector manufacturing

High-throughput screening for viral vectors

Viral vector manufacturing

Maximizing protein expression