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 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. 

Pablo Mendes de León

CFO

Pablo Mendes de León is a member of the Management Team of Batavia Biosciences. Pablo joined Batavia in November 2018.

Before joining our company he held several senior positions within the real estate industry. Prior to this he worked as financial controller and shared service manager in the technical industry and before that he started his career at KPMG. He holds a post-master in Auditing from the VU Amsterdam.

Within Batavia Biosciences, Pablo is responsible for Finance and IT.

Low-cost viral vector manufacturing

High-throughput screening for viral vectors

Viral vector manufacturing

Thermostable viral envelope protein formulation

Maximizing protein expression