New Test for Rapid and Low-cost Quality Control for Polio Vaccines

New Test for Rapid and Low-cost Quality Control for Polio Vaccines

Leiden, March 2024 – Batavia Biosciences, a contract development manufacturing organization, introduces a new low-cost, and fast tool, suitable for quality control of polio vaccines. This transformative advancement, described in the peer-review journal Vaccine, will provide substantial benefits in the final phases of the global poliovirus eradication efforts.    

To ensure the quality of the poliovirus vaccines and mitigate the risk of producing low immunogenicity batches owing to mutation accumulation in the poliovirus strain during production under laboratory conditions, rigorous monitoring is essential. Currently, this analysis is performed by next-generation sequencing (NGS). However, due to the high cost and time-consuming process, there is a need for a more suitable alternative for analyzing the genetic make-up of virus strains in polio vaccines.  

Lizet Opmeer, vaccine development scientist at Batavia Biosciences and author of the study: “Our mission is to drive innovations that improve vaccine production and ensure that vaccines are globally accessible. By introducing this groundbreaking and cost-saving tool, we aim to significantly contribute to the global effort of eradicating polio.”  

Batavia Biosciences developed a rapid alternative test that is low-cost, highly sensitive and can accurately detect mutations in poliovirus vaccines. Specifically, the new tool is a variant (allele)-specific locked nucleic acid-based reverse transcription quantitative real-time PCR (AS LNA qPCR) technology. This new tool offers comparable results to NGS but with a fraction of the cost and time, improving the quality control process of polio vaccines and potentially reducing production expenses.  

The analytic tool can be applied to measure and control the product quality during process development, scale-up, and release of the vaccine. Also, it is likely applicable to other vaccine strains, serotypes, and mutations. 

This advancing research, conducted in collaboration with Genomescan and with the financial support of the Bill & Melinda Gates Foundation, underscores Batavia Biosciences’ commitment to advancing healthcare technology. Through ongoing projects and initiatives, the organization strives to create lasting positive impacts on global health outcomes, ensuring the availability of safe and affordable biopharmaceuticals for all.

More about AS LNA qPCR test  

AS LNA qPCR, which stands for variant-specific locked nucleic acid-based reverse transcription quantitative real-time PCR technology, is a powerful method that can be used to identify different versions of genes, DNA sequences, or single nucleotide polymorphisms (SNPs). This technique involves converting RNA into DNA and subsequently amplifying and quantifying the DNA in real-time using Quantitative Real-Time Polymerase Chain Reaction (qPCR). The detection of SNP variants is achieved by utilizing fluorescent dye-labeled probes containing Locked Nucleic Acid (LNA), a stable form of modified nucleic acids, which specifically targets and detects specific SNPs.  

It’s like a super-accurate genetic detective tool that can help to find different gene versions. In this case this test specifically detects mutations that can accumulate in poliovirus strains during vaccine production. 

About the study 

“High throughput AS LNA qPCR method for the detection of a specific mutation in poliovirus vaccine strains” by Lizet Opmeer, et al. https://doi.org/10.1016/j.vaccine.2024.01.103, as published in Vaccine, by Elsevier

 DOI: 10.1016/j.vaccine.2024.01.103 
 

About Vaccine 

Vaccine is the pre-eminent journal in the field of vaccinology. It is the official journal of The Japanese Society for Vaccinology and is published by Elsevier. 

https://www.sciencedirect.com/journal/vaccine

Copies of this paper are available to credentialed journalists upon request, please contact the Elsevier Newsroom at newsroom@elsevier.com. 

Batavia Biosciences Joins iAds – Intelligent Design of Adenovirus Vectors Program 

Batavia Biosciences Joins iAds – Intelligent Design of Adenovirus Vectors Program 

Leiden, March 7, 2024 – Batavia Biosciences, a leading contract development and manufacturing organization, is excited to announce its active engagement in the iAds – Intelligent design of Adenovirus vectors program. The iAds consortium brings together 6 partners from 5 European countries and aims to apply a disruptive approach for viral vector design. This strategic involvement underscores Batavia Biosciences’ commitment to advancing state-of-the-art research and fostering collaborations that drive innovation within the viral vector field. 

Gene therapy is emerging as a promising therapeutic approach to address many areas of currently unmet medical need, such as neurodevelopmental, or neurodegenerative disorders and cardiovascular diseases. A frequently used vector in these development programs is the adenoviral vector. In the iAds program, new adenoviral vectors will be developed with improved targeting of the cardiovascular or central nervous systems to overcome limitations imposed by the patient’s immune system and from off-target effects.

The iAds consortium brings Batavia Biosciences together with IGMM, Janssen Vaccines, CNB-CSIC, Umeå University and the University of Edinburgh and combines their expertise in structural biology, receptor biology, clinical gene transfer, immunology, vaccines and GMP manufacturing to establish a disruptive approach to viral vector design.

Batavia Biosciences has a long-standing track record in the development and manufacturing of viral vectors such as the adenovectors and is an integral player in the cell and gene therapy field. Its extensive experience in bioprocess development and industrial scale manufacturing will be leveraged to develop a manufacturing process for this new generation of adenovirus vectors and produce research batches for pre-clinical testing. This way Batavia aims to accelerate and streamline the development trajectory from early-stage discovery into the clinic.

Wilfried Bakker, Director Science & Innovation at Batavia Biosciences, adds: “This collaboration highlights our commitment to advancing scientific knowledge and reinforces our position as a center of excellence in the viral vector field.”

About iAds 

iAds, a European Innovation Council (EIC) Pathfinder project, aims to maximize the potential of adenovirus vector for vaccines and gene transfer. This project is made possible in part by a contribution from the European Innovation Council under the grant agreement No 101098647.

For more information, please visit www.intelligentadenoviruses.eu

Batavia Biosciences Joins NXTGEN Hightech Program, to Advance Cell and Gene Therapy 

Batavia Biosciences Joins NXTGEN Hightech Program, to Advance Cell and Gene Therapy 

Leiden, January 9, 2024 – Batavia Biosciences, a contract development and manufacturing organization, is excited to announce its active participation in the NXTGEN Hightech Biomedical program. The NXTGEN Hightech program brings together many partners across several domains to deliver structural and sustainable economic growth in The Netherlands and contribute to solutions for societal challenges in health care, energy transition, safety and food. By joining the NXTGEN Hightech program, Batavia Biosciences is committed to advancing the cell and gene therapy field. 

The NXTGEN Hightech is a National Growth Fund program that aims to strengthen The Netherlands’ position as global leader in high-tech innovation. NXTGEN Hightech is a major investment in the future of the national economy and brings together over 330 partners across disciplines. It is a bold and ambitious program that has the potential to make a real difference in the world.

Wilfried Bakker, Director Science & Innovation at Batavia Biosciences, adds: “At the core of the program is Batavia Biosciences’ key focus on the development of environmentally friendly, reproducible, sustainable and cost-effective manufacturing technologies for new therapies in high demand.”

Addressing the critical aspect of cell culturing in the development of cell and gene therapies, this biomedical program emphasizes the need for new equipment and materials to improve process control. Batavia Biosciences is actively involved in this project with the goal of facilitating the adoption of sensor technology by pharmaceutical and biotech companies, which is critical for guaranteeing reproducible and lower-cost manufacturing for new therapies. This includes advancements and demonstration of sensors in a production setting, playing a crucial role for the evaluation of the innovative technologies.

Batavia Biosciences has a strong track record of offering state-of-the-art development and manufacturing solutions for viral vectors and is an integral player in the cell and gene therapy field. Its extensive experience in bioprocessing makes Batavia Biosciences a valuable partner in demonstrating new sensor technologies in a production environment.

Menzo Havenga, CEO Batavia Biosciences, concludes: “Beyond collaboration, the company is dedicated to being a driving force in the NXTGEN consortium, actively shaping the future of production and process technologies for life-changing therapies.”

About NXTGEN Hightech 

This project is made possible in part by a contribution from the National Growth Fund program NXTGEN Hightech. This program will invest as much as € 1 billion until 2030 with over 330 partners, in more than 60 projects and in six essential domains. In doing so, NXTGEN Hightech will make a significant contribution to the structural and sustainable economic growth in the Netherlands and offer solutions for the major societal challenges in the areas of energy transition, health, safety and food.  

For more information, please visit www.nxtgenhightech.nl 

Batavia partners in consortium to develop vaccine against Rift Valley fever 

Batavia partners in consortium to develop vaccine against Rift Valley fever 

Batavia Biosciences is proud to be a key partner in an important initiative aimed at combating the deadly Rift Valley fever. We are thrilled to share that as part of the consortium working alongside esteemed partners such as Wageningen Bioveterinary Research, Bunyavax BV, CR2O BV, University of Veterinary Medicine Hannover, and Integrum Scientific, LLC, we are stepping up our efforts to bring a protective vaccine to East Africa, where Rift Valley fever is endemic.

Batavia’s role as consortium partner

Our role in this endeavor is pivotal. At Batavia, we strive to reduce human suffering from infectious disease by helping improve vaccine affordability and availability around the world. Therefore, we have specialized in developing highly intensified manufacturing processes, leveraging our cutting-edge HIP-Vax® platform to create vaccines with a low cost of goods. As a consortium partner, our primary focus is on developing a scalable manufacturing process that can be rapidly scaled-up in the event of an outbreak. Furthermore, we are honored to take on the responsibility of manufacturing the clinical material for the Phase I and IIa trials planned for East Africa.

This initiative is a significant milestone in our ongoing battle against infectious diseases, particularly Rift Valley fever. The project, generously supported with up to US$25.9 million in funding from CEPI and backed by the European Union’s Horizon Europe program, will accelerate the development of a much-needed protective vaccine in East Africa.

Rift Valley fever: A climate-driven disease with epidemic potential

Rift Valley fever is a potentially lethal virus that can be transmitted to humans through mosquito bites or contact with infected livestock. With climate change increasing the risk of RVF outbreaks, the need for a protective human vaccine has never been more urgent. As a ‘One Health’ priority, the development of safe and effective human vaccines for RVF is crucial, and we are committed to playing our part in this vital endeavor.

Together with our esteemed partners and the support of CEPI and the European Union, we are determined to make a difference in the fight against Rift Valley fever.

Read the full press release for more details: CEPI expands partnership with Wageningen Bioveterinary Research to advance clinical trials of Rift Valley fever vaccine in affected countries – CEPI

Low-cost viral vector manufacturing

High-throughput screening for viral vectors

Viral vector manufacturing

Thermostable viral envelope protein formulation

Maximizing protein expression