RCS - Viralgen Commercial - Viralgen GMP certification rAAV commercial product

Bayer AGAnnouncement

09/01/2023 08:45

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RNS Number : 0084M  Viralgen Commercial Therapeutic  09 January 2023

 

 

 

 

Viralgen receives cGMP certification to produce rAAV commercial grade product
at new facility in San Sebastian, Spain

 

-- Certification expands Viralgen's capacity threefold and positions the
company as a world-leading CDMO --

-- New facility operates single-use bioreactors from 50 to 2,000 liters and
manufactures research, clinical and commercial grade rAAV vectors using
Pro10™, the leading cell line on the market --

 

09/01/23. San Sebastian. Viralgen Vector Core (Viralgen), an independently
operated subsidiary of Asklepios BioPharmaceutical, Inc. (AskBio), and a
member of the Bayer worldwide group of companies, has received Certified Good
Manufacturing Practices (cGMP) certification for the manufacture of human
medicinal products, investigational medicinal products and sterile or
biological active substances. This certification was granted following a
successful inspection by the Spanish Agency for Medicines and Medical Devices
(AEMPS), a part of the European Medicines Agency (EMA) network. The company
now operates two facilities in San Sebastian, Spain, with seven
state-of-the-art single-use suites that have up to 2,000 liters of
manufacturing capacity, making it a world-leading contract development and
manufacturing organization (CDMO).

Viralgen is now licensed for the commercial manufacturing of recombinant
adeno-associated virus (rAAV) gene therapies up to 2,000 liters and has
completed seven successful runs at this maximum scale. This first phase of the
expansion of the new facility, which has added 300,000 square feet of clinical
and commercial rAAV manufacturing, is now complete. The new facility currently
has three independent state-of-the-art quality control labs and commercial
manufacturing suites with 500- and 2,000-liter single-use bioreactors.
Viralgen anticipates opening additional manufacturing, science and technology
(MSAT) and analytical development space at the same facility at the end of Q1
2023.

 

"Being a fully integrated CDMO, we offer a continuum of products and services,
including process, analytical development, stability studies and fill and
finish for all types of rAAV serotypes," said Jimmy Vanhove, CEO of Viralgen.
"This can significantly shorten the time to market, help with predictable cost
of goods and reduce the waiting time experienced by patients who have run out
of options and hope for breakthrough treatments."

 

With this approval, Viralgen expands its ability to partner with customers in
the rAAV space that are initiating Phase III studies and seeking approvals to
commercialize their products. This builds on the company's achievement of its
2022 pivotal milestone, which was the manufacturing over 135 batches of
clinical and preclinical material, and its enabling more than 24 INDs since
its inception in 2019.

 

"With this certification, we have three times the rAAV production capacity we
had previously. This solidifies our position as a global leader in the CDMO
rAAV field", said Javier García, co-founder and Chairman of the Board of
Viralgen. "We are now able to manufacture at the industry's largest scale and
supply Phase III and commercial products for our global customers."

 

Viralgen was created in 2017 to respond to the unmet need for the
manufacturing of gene therapies, with the goal of helping broaden access to
these life-saving therapeutics around the world. Viralgen specializes in the
production of rAAV vectors and has built an optimized facility that maximizes
the throughput and efficiency of the proprietary Pro10™ based suspension
manufacturing platform, enabling industry-leading yields, scalability and
speed to market. Viralgen is a fully integrated company, which supplies
research, cGMP and commercial grade material from 250 to 2,000 liters in
scale, including process development, formulation and filling.

 

About Viralgen

Viralgen, an independently operated Contract Development and Manufacturing
Organization (CDMO), was founded in 2017 as a joint venture between AskBio and
Columbus Venture Partners (a venture capital firm based in Spain). As one of
the world's leading manufacturers of cGMP-certified AAV, Viralgen uses the
Pro10™ based suspension manufacturing platform, a technology licensed from
AskBio and developed by co-founder R. Jude Samulski, PhD, at University of
North Carolina. It is believed that Pro10™ increases scalability,
performance and precision of AAV therapies. Located in Spain, in the Gipuzkoa
Science and Technology Park, Viralgen produces AAV gene therapy treatments for
pharmaceutical and biotech companies with the aim of accelerating the delivery
of new treatments that can improve patients' lives.

 

The company's clinical facilities have four cGMP manufacturing suites, with
250-liter and 500-liter bioreactors. In 2020, Viralgen expanded within the
Scientific Park by constructing a new building for increased manufacturing
capacity. The new space includes three additional cGMP suites with a
manufacturing capacity of 2,000 liters each.

Viralgen has more than 420 employees, with three quarters of these holding
advanced degrees. This talented workforce supports a range of core
capabilities in quality assurance, quality control, analytical development and
process development, all of which are critical to shortening the time to
market and supporting customers with the regulatory process.

 

 

For more information, visit viralgenvc.com.

 

For more information and interviews, please contact:

Priscilla Assumpção

+34 640 817 276

passumpcao@viralgenvc.com (mailto:passumpcao@viralgenvc.com)

 

 

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