Batavia enters commercial manufacturing

Batavia enters commercial manufacturing

Batavia enters commercial manufacturing

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Leiden, The Netherlands, June 28, 2022 – Today, Batavia Biosciences  announces that it will extend its CDMO services portfolio (R&D and clinical manufacturing) to include commercial manufacturing services. The company has finalized the design plans of its new 12.000 square meter building to be realized at the Bioscience Park in Leiden, The Netherlands. It is expected that the manufacturing facility will be operational around Q3- 2024.

The multi-product facility is designed to support the late-stage clinical manufacturing and commercial manufacturing of vaccines and viral vector-based gene therapy and immune-oncology products. Batavia’s highly intensified manufacturing technology, HIP-Vax®, which utilizes fixed-bed bioreactors, will be the main platform, but also products manufactured using traditional mammalian cell suspension technologies up to 1000L scale can readily be delivered. The facility is based on a modular design, with 6 production suites. On-site, state-of-the-art fill / finish capabilities ensure on-time delivery of drug product. Depending on virus / vector type the facility is expected to provide for several hundred million doses annually.

Batavia is proud to have assembled a strong team to ensure ambitious timelines are met. Developer Provast is contracted to deliver the shell and core of the facility. Batavia engaged with VILS, a leading process-design, engineering and project-delivery company for the engineering and design.

Menzo Havenga, CEO of Batavia Biosciences, states: “This is a major step for Batavia as the company transitions from a CDMO that could assist its clients in R&D and clinic manufacturing only, to now, a “one-stop-shop” where it will be able to support clients from concept product idea all the way to full market launch and commercial manufacturing.

Chris Yallop, CSO at Batavia Biosciences, adds, “This facility provides a valuable resource to ensure the manufacture of critical new medicines including low-cost global health vaccines, epidemic and pandemic preparedness vaccines, gene therapy and virotherapy treatments.”

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Batavia At LBSP ATMP TechTalks

Batavia At LBSP ATMP TechTalks

Batavia At LBSP ATMP TechTalks

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Eize De Boer showed us what it takes to realize a new facility for Batavia Biosciences designed for viral vector manufacturing to support developers on a global scale.

The multi-product facility is designed to support the late-stage clinical manufacturing and commercial manufacturing of vaccines and viral vector-based gene therapy and immune-oncology products. Batavia’s highly intensified manufacturing technology, HIP-Vax®, which utilizes fixed-bed bioreactors, will be the main platform, but also products manufactured using traditional mammalian cell suspension technologies up to 1000L scale can readily be delivered.

The facility is based on a modular design, with 6 production suites. On-site, state-of-the-art fill / finish capabilities ensure on-time delivery of drug product. Depending on virus / vector type the facility is expected to provide for several hundred million doses annually.

 

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LUMC & Batavia Biosciences Burst the Bubble

LUMC & Batavia Biosciences Burst the Bubble

LUMC & Batavia Biosciences Burst the Bubble

Batavia Biosciences - Favicon

Severe Combined Immunodeficiency (SCID) disease affects 1 in 35,000 newborns annually, of which approximately 145 are babies in the European Union. These children are born without a functional immune system, making them seriously ill from infections. Without treatment, they often die within their first year of life. SCID is treated with blood stem cell transplantation. But what if there is no suitable donor?

Frank Staal is a molecular stem cell biology professor at Leiden University Medical Center (LUMC) and has developed a stem cell gene therapy to cure children with a specific form of SCID (RAG1-SCID). This was already successful in 2022 with a three-month-old boy. “His immune system is indistinguishable from a normal immune system,” says Frank Staal. In this article, you can read about the challenges and what it took to achieve this success.

Baby cured of SCID with stem cell gene therapy

“When we saw that we cured the child, we were euphoric,” says Frank Staal. “We also celebrated with a glass of champagne because of the remote corona”.

The LUMC is one of the two centers in the Netherlands where stem cell transplants for children occur. “Gene therapy is a very nice extension of that,” says Frank Staal. “If there is no suitable donor, we can apply stem cell gene therapy. We modify the body’s cells using viral vectors and return these cells. This has several advantages: for example, there is no risk of graft-versus-host disease.”

A phase 1 trial is currently underway. Frank Staal hopes to complete the first phase of the clinical trial within two years. “We have received many candidates but are very strict in the selection procedure. As a result, we see many children who do not officially have SCID or already have a suitable donor. We are now in talks with other countries to be able to cure patients there.”

Challenges with the vector

“Modified stem cells are returned to the body. This modification takes place using viral vectors. It took a lot of time in the lab to figure out how to make a vector that no longer replicates but can still integrate into the host’s DNA,” says Frank Staal. “Then you look for a party that can produce the vector on a large scale for all the quality tests and, ultimately, the clinical trials. Fortunately, we have Batavia Biosciences, a contract development and manufacturing organization (CMDO), just around the corner. They had no experience with this type of viral vector yet, but they did have experience with viral vaccines. In addition, they have a good reputation. Ultimately, they delivered a product that works excellently and has been used to cure the first patient.”

The collaboration with Batavia Biosciences

“I think our collaboration is unique,” says Frank Staal. “Traditionally, you give the vector to a production company, and after that, there is hardly any contact. Instead, Batavia Biosciences and the LUMC did it together.”

Wilfried Bakker, director of Science and Innovation at Batavia Biosciences, agrees. “Batavia Biosciences already had a lot of experience and expertise in the field of viral vaccines. Frank Staal’s project suited us well because viral vectors are similar to viral vaccines. We enter into a conversation and keep talking during the development process. That is what distinguishes Batavia Biosciences. In this way, we ensure that the quality of the product is maintained while the costs remain low. We do this, among other things, by creating a scalable process in which the product continues to meet the quality requirements. With our platform technology, we can also achieve this relatively quickly.”

“The recovery of the first patient is, of course, a huge milestone. I was overjoyed, and the team was super enthusiastic”, Wilfried Bakker continues. “Contributing to these kinds of projects is the biggest motivation at Batavia Biosciences.”

Next steps

Batavia Biosciences is building a new facility, which should be ready in 2024. “Our vision is to continue to grow in viral vaccines and virotherapy. For stem cell gene therapy for immune diseases and oncolytic therapy,” says Wilfried Bakker proudly. “In the new facility, we can use certain technology, which allows us to keep processes efficient. This advantage will keep costs low and viral vaccines and virotherapy will be more widely available.”

That is also important for Frank Staal. “Ultimately, you want to make it easier and more affordable for families to have their child cured of SCID and other immune diseases. We need enough viral vectors for this, not just at the current clinical trial level. Batavia plays a major role in this process because they developed the viral vector with us and are experts in scaling up these types of processes.”

Finally, Frank Staal says: “I think the outlook for gene therapy is favorable: one treatment is enough to cure a child for life. That is very special.”

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Batavia Biosciences is expanding its viral vector process development capacity in Massachusetts

Today, Batavia Biosciences announces the expansion of its process development facilities in Woburn, MA, United States to accommodate the increasing market demand for viral vectors.

Chris Yallop, COO at Batavia Biosciences, explains: “Advances in immuno-oncology, infectious diseases and gene therapy have given rise to a profound increase in the global demand for process development and clinical manufacturing of viral vector based products.”

The R&D facility in Woburn, located just north of Cambridge (MA) allows Batavia Biosciences to expand its process development capacity for its HIP-Vax® platform. Through innovative bioprocess intensification, HIP-Vax technology allows clinical manufacturing at a lab-scale. The highly intensified production processes developed by Batavia, have significantly lower cost-of-goods compared to traditional production platforms.

Menzo Havenga, CEO at Batavia Biosciences, adds: “Especially in the field of virotherapy, current low production yields force developers to a use relatively large scale equipment even to support phase 1 and 2 clinical trials. Our HIP-Vax technology platform provides a rapid and cost-effective alternative, providing a scalable and robust process using a bench-scale manufacturing footprint.”

The newly added R&D spaces are fully equipped to provide production, purification and analytical support for diverse viral vectors including lentiviral and AAV vectors.

Ingrid van Aarle, HR manager at Batavia Biosciences, says: “We are always on the lookout for new talent, especially with the new infrastructure coming online soon. Scientists and technicians, who wish to contribute to making potential life-saving biopharmaceuticals more affordable and better available and want to develop their careers in the exciting world of viral vectors, are invited to apply via Batavia’s jobs page.”

Menzo concludes: “At Batavia Biosciences, we are aware every day that the patient is waiting. With the completion of this build-out, we are well positioned to maintain speed and quality of bringing candidate biopharmaceuticals from the bench to the clinic.”

Univercells and consortium partners Batavia Biosciences and Natrix Separations Received $12 Million Grant by Bill & Melinda Gates Foundation to Radically Reduce Vaccine Costs for Developing Countries

Brussels, Belgium, December 15, 2016 – Univercells announced today that it has been awarded a $12 million grant by the Bill & Melinda Gates Foundation for the development of a breakthrough vaccine manufacturing platform with the objective of radically lowering costs and increasing vaccine availability and affordability in developing countries. The development will be performed by a consortium which also includes Batavia Biosciences and Natrix Separations.

Hugues Bultot, CEO and co-founder of Univercells said: “We are extremely honoured to partner with the Gates Foundation to significantly increase global access to priority vaccines by lowering their manufacturing cost”.

Vaccines are a powerful contributor to the improvement of global health, with corresponding economic and societal value in averted costs, productivity gains and poverty reduction. A number of factors limit complete global immunization coverage, including prohibitive costs for procuring and distributing vaccines in lower income countries. A substantial reduction in the cost of manufacturing vaccines could help enable affordable, equitable and sustainable immunization on a global scale.

Under the terms of the agreement, the consortium will develop a manufacturing platform that integrates continuous processing with extremely high process intensification. This combination allows miniaturization of commercial manufacturing to the point where it can be performed in locally deployed, self-contained, small footprint, low-cost micro-facilities. The platform will leverage Univercells’ process intensification and integration capabilities and technologies; Natrix’s novel single-use chromatography membrane platform; and Batavia’s vaccine development and manufacturing capabilities. The initial target is to establish a micro-facility for inactivated polio vaccine (sIPV) that can deliver 40 million doses of trivalent vaccine per year at a manufacturing cost of less than $0.15 per dose. The platform concept can be applied to any viral vaccine and the reduced scale and simplified operations that it delivers will lower the hurdles for vaccine manufacturers in developing countries while maintaining high safety and containment.

José Castillo, CTO and co-founder of Univercells, stated: “We are excited about this partnership with the Bill & Melinda Gates Foundation. With Batavia Biosciences and Natrix Separations, our consortium integrates considerable experience, know-how and innovative but proven technologies that tremendously increase manufacturing productivity. As a result, we expect our integrated platform to be a real game-changer for global health.”

Low-cost viral vector manufacturing

High-throughput screening for viral vectors

Viral vector manufacturing

Thermostable viral envelope protein formulation

Maximizing protein expression