A fully integrated, commercial-stage biotech company focused on developing innovative lifesaving vaccines: Valneva

Valneva, a biotech company was born to contribute to a world where no one dies or suffers from a vaccine-preventable disease. Valneva aims to become the leading vaccine company by complementing product sales growth with the development of high-value R&D assets. Valneva's mission is to help protect the lives of people around the world through the discovery, development, and commercialization of innovative vaccines against infectious diseases. 

The Company's clinical pipeline includes a unique vaccine candidate against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada, and the US, with over 450 employees.

Manufacturing

The production of Valneva’s Vaccine: Vaccine manufacturing is considered to be extremely demanding: Valneva’s production facilities operate according to high-quality standards, which are regularly and rigorously verified by Valneva’s partners and by multiple regulatory authorities. Valneva GMP manufacturing operations cover the internal and external production of clinical and commercial products.

Valneva's manufacturing plant in Livingston is currently dedicated to the production of the company’s leading product, IXIARO^®/JESPECT^®, a vaccine indicated for the prevention of Japanese encephalitis. The modern production facility with an installed capacity of more than 1.5 million doses fulfills all cGMP requirements and provides for a very efficient production process.

Valneva manufactures the cholera vaccine DUKORAL^® at its fully owned site in Solna, Sweden. The Solna site has been a Valneva-owned entity since its acquisition in 2015 and includes facilities for viral as well as bacterial vaccine production. The facility operates under respective manufacturing licenses from the Swedish Medical Products Agency (MPA) with an installed capacity of more than 2.5 million doses.

Influenza vaccine manufacturing: In March 2014, Valneva announced the first ever marketing approval for a human vaccine produced in the EB66^® cell line.  The approval was granted by the Japanese health authorities to the Chemo-Sero Therapeutic Research Institute (Kaketsuken), a co-development partner of GlaxoSmithKline (GSK), for a pandemic H5N1 influenza vaccine. The vaccine has been developed in accordance with the Japanese government’s plan to rapidly respond to an influenza pandemic both before and during an outbreak. 

Technologies

The EB66® cell line: It is a proprietary embryonic stem cell-based technology for the production of a wide variety of human and veterinary viral and therapeutic vaccines.

It can be used for the manufacturing of inactivated viruses, live attenuated viruses, live vectors, and subunit vaccines.

The first human vaccine produced using the EB66^® technology received marketing approval in 2014 and the first veterinary vaccine in 2012. The first veterinary vaccine produced in EB66^® cells obtained licensure in 2012 and the H5N1 adjuvanted pandemic Influenza vaccine produced by the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) in collaboration with GSK on Valneva’s proprietary EB66^® cell line program is currently in a New Drug Application (NDA)-Phase in Japan.

IC31^® adjuvant: The unmet need in population groups which do not respond sufficiently to conventional vaccines due to an impaired immune response (e.g., the elderly) and the difficulties in eliciting meaningful responses to novel prophylactic and therapeutic vaccines for indications such as malaria, tuberculosis and cancer increase the need for adjuvant such as IC31^®.  The role of adjuvants in vaccination is to non-specifically enhance and shape the immune response to specific antigenic components of vaccines through targeted activation of the immune system.

IC31^® is a totally synthetic vaccine adjuvant which can be simply added to target antigens to improve vaccine response. IC31^® has demonstrated activity in clinical trials supported by a very good safety and tolerability profile. The technology has been licensed to a number of vaccine companies.

Valneva’s development and testing services

Based on Valneva’s experience in vaccine development and production, Valneva provides broad cGMP compliant, efficient and timely development and testing services for commercial and clinical products across all clinical and pre-clinical phases.

Valneva is offering the following services to support clinical vaccine programs:

• Process development and CTM production for viral and bacterial vaccines
• Analytical development and release, stability testing service
• In vivo testing for PoC and immunogenicity, safety assessment
• Clinical immunology assay development and sample testing service

Salutations to the mastermind

Thomas Lingelbach, President, and Chief Executive Officer: Thomas Lingelbach was appointed President, and CEO of Valneva. He has been with Intercell since 2006, serving as COO until 2011 and since then as CEO. He has held a variety of positions of increasing international responsibility in his more than 25 years in the pharma and vaccine industry. He joined Intercell from Novartis Vaccine & Diagnostics as Managing Director Germany focusing on the integration with Chiron Vaccine where he served as Vice President Global Industrial Operations and Managing Director Chiron-Behring. Thomas Lingelbach holds a Master's degree in Engineering and complemented his education with a Business Administration program.

“We are a fully integrated vaccine company with two travel vaccines on the market.”