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 Biosciences Announces Release of GMP Production  Facility 

Batavia Biosciences Announces Release of GMP Production  Facility 

Leiden, November 21, 2023 – Batavia Biosciences, a Center of Excellence Contract Development and Manufacturing Organization (CDMO), proudly announces the release of ‘Amalia,’ a GMP-ready manufacturing facility in Bilthoven, Netherlands. This strategic move represents a significant leap in Batavia’s capabilities to deliver clinical manufacturing of viral vaccines and viral vectors. 

Menzo Havenga, CEO Batavia Biosciences, says: “The release of this facility is a significant achievement for our company. It supports Batavia Biosciences’ mission of being a center of excellence able to support customers’ vital efforts to bring essential medical countermeasures from the lab to the patients who need them most. This facility is critical to increasing clinical manufacturing capacity to align with market needs and support epidemic preparedness.”   

Accommodated within a space leased from Bilthoven Biologicals, ‘Amalia’ is Batavia Biosciences’ response to the growing demand for high-quality clinical manufacturing and epidemic preparedness. The facility houses advanced equipment and complying with stringent quality standards, making it a cornerstone for innovation in viral vector and vaccine development and production. 

Amalia maintains up to Grade B cleanroom standards to ensure sterile and safe production environments. Equipped with two upstream suites, the facility is designed for parallel manufacturing of viral vectors and vaccines at volumes reaching 200 liters. Leveraging advanced single-use technologies suitable for suspension and adherent cells, the facility operates under strict Biosafety Level 2 (BSL-2) protocols, enabling the safe handling of pathogens such as Measles, Herpes Simplex, and Influenza. 

This endeavor is part of a larger expansion strategy supported by active investment from CJ CheilJedang, aligning with Batavia Biosciences’ vision to establish Batavia Biomanufacturing. The Amalia facility is a steppingstone towards the ambitious launch of the more extensive, state-of-the-art facility in Leiden. Once operational, the Leiden site is expected not only to complement but eventually supersede Amalia with a daily production capacity planned to reach an impressive 576,000 vials. 

Amalia’s release will enable Batavia Biosciences to consolidate its position further, offering end-to-end solutions to bring therapies from scientists to patients. 

For press inquiries and more information, stay tuned for upcoming announcements from Batavia Biosciences. 

About Batavia Biosciences 

Batavia Biosciences significantly contributes to ease human suffering from infectious diseases, cancer, and rare diseases by leveraging our innovative technologies and in-depth know-how. We do this for viral vaccines and cell and gene therapies at all stages of the development trajectory, from the transition into early clinical studies, to navigating late-stage clinical development and entering commercial manufacturing at higher speed, reduced costs, and with increased success. The company operates state-of-the-art development and manufacturing facilities in Europe and the US and, as part of the CJ CheilJedang global family, is building a strong position in global health with its strategic partners worldwide.  

Batavia Biosciences Announces Collaboration with Phoenix Nest Inc. to Accelerate Development of Therapeutics for Sanfilippo Syndrome

Batavia Biosciences Announces Collaboration with Phoenix Nest Inc. to Accelerate Development of Therapeutics for Sanfilippo Syndrome

Woburn, MA, 16 October 2023 — Batavia Biosciences, a leading global Contract Development and Manufacturing Organization, announced a new partnership with Phoenix Nest Inc., a bespoke biotech company focusing on treating ultra-rare diseases. The collaboration aims to fast-track the development and production of recombinant human N-acetylglucosamine-6-sulfatase (rhGNS) for treatment of Sanfilippo syndrome, a rare genetic disorder.

Batavia Biosciences will perform crucial process and analytical development for Phoenix Nest Inc. This work will enable the future production of rhGNS for toxicity studies and establishing a scalable, Good Manufacturing Practice (GMP)-compatible process.

“We are very pleased that Phoenix Nest decided to contract Batavia Biosciences based on our proven track record and technological expertise. We are honored to collaborate and provide solutions for patients battling Sanfilippo syndrome.” says Peter Abbink, PhD, Managing Director at Batavia Biosciences, Inc., located in Woburn, MA.

The need for high-quality, specialized therapeutics for Sanfilippo syndrome remains an urgent priority. Affected individuals often face severe neurological symptoms with limited treatment options. This collaboration aims to advance the scientific understanding and accelerate the development of treatments for this devastating disease.

“Phoenix Nest is developing therapies for Mucopolysaccharidosis type III (MPS III), also referred to as Sanfilippo Syndrome. We made significant progress towards the development of an enzyme replacement therapy for Sanfilippo syndrome type D, including an observations study [NCT05648851] in MPS IIID patients. We are excited about our collaboration with Batavia for our enzyme manufacturing and scale-up development” stated Jill Wood, CEO, Phoenix Nest Inc.

About Phoenix Nest Inc.

Phoenix Nest Inc. is a bespoke biotechnology company specializing in developing innovative therapies for ultra-rare diseases, with a primary focus on Sanfilippo syndrome. Sanfilippo syndrome (Mucopolysaccharidosis III), a set of genetic neurodevelopmental disorders that result in progressive neurological, developmental, and physical regression. The impacted individuals require life-long medical and supportive care as there are no approved cures or treatments.  Phoenix Nest is the proud recipient of several Small Business Innovation Research grants from the National Institute of Health. Through funding from the NIH under Award Number U44NS089061, we have been able to facilitate the research in academic labs and licensed these programs for development and translation to clinical interventions.

About Batavia Biosciences

Batavia Biosciences significantly contributes to ease human suffering from infectious diseases, cancer, and rare diseases by leveraging our innovative technologies and in-depth know-how. We do this for viral vaccines and cell and gene therapies at all stages of the development trajectory, from the transition into early clinical studies, to navigating late-stage clinical development and entering commercial manufacturing at higher speed, reduced costs, and with increased success. The company operates state-of-the-art development and manufacturing facilities in Europe and the US and, as part of the CJ CheilJedang global family, is building a strong position in global health with its strategic partners worldwide.

Media Contacts

Phoenix Nest Inc.

Jill Wood, CEO

jwood@phoenixnestbiotech.com

Batavia Biosciences

Peter Abbink, Managing Director

p.abbink@bataviabiosciences.com

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

Batavia Biosciences Joins the Alliance for Regenerative Medicine 

Batavia Biosciences Joins the Alliance for Regenerative Medicine 

Batavia Biosciences is excited to announce its new Alliance for Regenerative Medicine (ARM) membership. ARM is a premier international advocacy organization that brings regenerative medicines and advanced therapies to patients worldwide. By joining ARM, Batavia Biosciences is committed to advancing the cell and gene therapy field. 

“By aligning ourselves with the Alliance for Regenerative Medicine, we are strengthening our commitment to the broader cell and gene therapy community. Our primary objective is to help innovators develop and deliver ground-breaking therapies that can change and save lives,” says Peter Abbink, PhD, Managing Director at Batavia Biosciences, Inc., located in Woburn, MA. “Our extensive expertise in bioprocessing makes us a valuable partner in accelerating the journey of these therapies from the lab to the market. We aspire to be a key collaborator in a consortium where we can substantially contribute to enhancing the quality of life for patients and caregivers.” 

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. Through its cutting-edge HIP-Vax® platform technologies and services, Batavia Biosciences facilitates the rapid development and scalable manufacturing of life-changing therapies, while significantly reducing the cost of goods. Innovative bioprocess intensification technologies pave the way for significantly improved production of viral vector products, used in gene therapy and immuno-oncology. 

About The Alliance for Regenerative Medicine 

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. As a community, ARM builds the future of medicine by convening the sector, facilitating influential exchanges on policies and practices, and advancing the narrative with data and analysis. We actively engage key stakeholders to enable the development of advanced therapies and modernize healthcare systems so patients benefit from durable, potentially curative treatments. 

As the global voice of the sector, we represent more than 400 members across 25 countries, including emerging and established biotechnology companies, academic and medical research institutions, and patient organizations. 

Batavia: Lentivirus for first patient NL

It is with great enthusiasm and excitement that we would like to congratulate Leiden University Medical Center and the research team on their recent accomplishment using the lentivirus. Researchers have successfully treated a baby with stem cell gene therapy for severe combined immunodeficiency disease (SCID). This form of SCID (which often claims the life of the victim before finishing their first year of life), had previously never been treated with gene therapy and now the disease has been successfully cured.

Batavia Biosciences is proud to announce that we were able to play a role in helping reduce human suffering as Batavia produced the lentivirus vector for this incredible project. Professor Frank Staal references the lentivirus vector as the “wheelbarrow that brings the gene to the right place” within the article. It’s apparent that amazing work is being done by the top names in the gene therapy field, and we are honored to be able to contribute with our expertise in viral vectors, specifically, the lentivirus in this project.

Wilfried Bakker, Director of Science and Innovation, states, “To be part of this development, we could not be prouder. Our contribution of the lentivirus vector to treat this form of SCID means a lot to us, but even more to the patient and future patients with this life-threatening form of SCID.”

Read the full press release with the links provided:

Volkskrant Article 
LUMC Press Release

Low-cost viral vector manufacturing

High-throughput screening for viral vectors

Viral vector manufacturing

Thermostable viral envelope protein formulation

Maximizing protein expression