CELL AND GENE THERAPY

Valneva and IDT Biologika Announce Collaboration for Production of Inactivated COVID-19 Vaccine VLA2001

Valneva SE, IDT Biologika | November 30, 2021

Valneva SE, a specialty vaccine company, and IDT Biologika announced their collaboration for the production of Valneva’s inactivated COVID-19 vaccine candidate VLA2001. This follows last week’s announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001, over two years.

Under the collaboration, IDT Biologika will produce VLA2001’s drug substance at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, in addition to Valneva’s manufacturing site in Livingston, Scotland.

 “IDT is a well-established partner within Valneva’s manufacturing network. As such we are extremely pleased to extend this partnership to supply VLA2001. This collaboration will help ensure our inactivated vaccine is available for rapid deployment as we continue to believe that our differentiated vaccine candidate can make an important contribution to the global fight against the COVID-19 pandemic.”


Thomas Lingelbach, Chief Executive Officer of Valneva

Dr. Jürgen Betzing, Chief Executive Officer of IDT Biologika, added, “This is great news for our company. This assignment shows the importance of the role played by IDT in the fight against COVID-19. It is a great achievement and demonstrates the trust that Valneva has placed in us and our employees. The expansion of our production capacity combined with our expertise were key factors in the choice of IDT.”

Valneva has continued to review its manufacturing strategy following discussions with the UK Government  in the summer and again after the termination of the UK contract in September 2021. Valneva plans to operate a combination of external and internal production of VLA2001 and will further review its manufacturing plans based on demand. The Company’s sites in Livingston, Scotland and Solna, Sweden will continue to form part of the Company’s core manufacturing strategy.

Valneva reported positive Phase 3 results for VLA2001 in October 20211. Delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the European Medicines Agency  which is expected to start a rolling review of VLA2001 shortly.

About VLA2001
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements.

About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

About IDT Biologika
IDT Biologika is an innovative biotech company with a successful history dating back 100 years. On the basis of modern technologies and high levels of expertise, we support customers in the development and manufacture of innovative virus vaccines, gene and immune therapy products as well as biologics employed worldwide as protection against diseases. German sites are the BioPharmaPark in Dessau-Roßlau and Magdeburg. In the US, the IDT Corporation has a manufacturing site for clinical test samples in Rockville, Maryland.




Spotlight

Pharma IQ has created an easy-to-digest overview of biomanufacturing activity and spend around the world, whether they are already being implemented or have plans in the near future. You’ll be able to keep it as a handy reference, share it around your colleagues or even stick it on your wall.


Other News
MEDICAL

ABC Opens Commercial MEL BioSurfactant Production in Irvine, CA

ABC | May 19, 2022

Advanced BioCatalytics (ABC) is pleased to announce the opening of our new biosurfactant commercial pilot plant in Irvine California. The plant reflects the successful collaboration of the ABC R&D team and Dr. Wenjie Xia, professor of Microbiology at Nankai University in Tianjin China. The commercial pilot plant is the first step in commercial scale up of new glycolipid (biosurfactants) and is the first plant to produce commercial quantities of mannosylerythritol lipids (MEL) in North America. ABC pioneered the use of microbiology to produce metabolites and sustainable chemistry in 1996. Our products are used in water treatment, the energy sector, for agriculture uses, and in personal and home care applications. By using microbiology, we can create natural alternatives to petrochemicals. For our production we upcycle waste feed stocks such as used vegetable oils or other sources of bio-waste material. As a result, our chemistry also offers an alternative to plant based materials which have the unfortunate reliance on certain plant species which are contributing to global deforestation and destruction of biodiversity. The MEL material can be used in a variety of ways in the homecare and personal care sectors. MEL is free of 1,4 dioxane, mild on the skin, and produces minimal foam. This superfatting agent is ideal for delivering moisture in personal care products and can be used along with anionic and amphoteric surfactants for improved efficacy. The addition of MEL production compliments ABC's rhamnolipid and BioSS RL fermactant production. About Advanced BioCatalytics: Advanced BioCatalytics is an industrial biotechnology company that leverages its innovative Fermactant technology for applications in the Home and Personal Care, Energy, Agriculture, and Wastewater markets. These products have demonstrated the ability to be highly cost-effective, without depending on harmful chemistries such as caustics, acids or dangerous solvents, which can be harmful to the user and/or the environment. Advanced BioCatalytics was founded in 1996 and we are excited to be introducing a new technology that will change the future performance, and cost, of the world's cleaning products.

Read More

MEDICAL

ImmunoTek Bio Centers First to Launch VeinViewer® Technology for Plasma Donations

ImmunoTek Bio Centers | April 27, 2022

Donating plasma is now easier, thanks to a smart new tool allowing technicians to see the map of veins inside a plasma donor's arm. ImmunoTek Bio Centers proudly announces its two divisions – ImmunoTek Plasma and Freedom Plasma – are the first blood plasma collection centers to use this groundbreaking technology. The VeinViewer®, developed by Christie Medical Holdings, has had great success in hospitals and medical clinics, and recently in pilot programs with ImmunoTek. Using the VeinViewer® in a plasma donation setting provides phlebotomists with real-time images of the donor's veins before needle insertion. The VeinViewer® uses direct projection vein illumination to identify vein patterns and display them on a patient's skin. As part of plasma donation, a needle is inserted into the donor's arm to withdraw blood that is then separated into individual parts during a process called plasmapheresis. Being able to easily see where the donor's veins are located helps phlebotomists as they insert the needle to begin the process. Our technicians found that using the VeinViewer® provides a clear look at a donor's veins before the needle is inserted. The ability to see this image increases their accuracy, makes the donation process faster, and reduces the likelihood of reinserting the needle, We are proud to be the first plasma collection company to offer this next-level service for our donors." Blair McKinney, Chief Operating Officer of ImmunoTek Bio Centers. We are delighted ImmunoTek selected Christie's leading vascular visualization technology to aid in establishing a comfortable environment and efficient encounter for donors." Paul Damiani, Christie Medical Holdings, Inc President. ImmunoTek has created an unparalleled donation ambiance and we look forward to integrating the unmatched VeinViewer for an even better donor experience." Lisa Kaufman, Vice President at Christie. The United States provides 2/3 of the world's supply of plasma, which is used to make critical life-saving medicines and plasma-based therapies. Blood plasma is in great demand and the need for it increases 6-8 percent yearly. Increasing plasma donations helps meet the need for plasma around the world. ABOUT IMMUNOTEK BIO CENTERS, LLC ImmunoTek Bio Centers LLC is the fastest-growing independent plasma collection center operator in the United States and is a global leader in developing a reliable plasma supply chain for biotech companies. Since its inception in 2013, ImmunoTek has built and operated more than 50 plasma collection centers, most of which are or are in the process of becoming FDA-licensed and EU-certified, with nearly 40 additional centers in progress. ABOUT CHRISTIE MEDICAL HOLDINGS, INC. Christie Medical Holdings is a medical device manufacturer based in Lake Mary, FL, USA. Our market-leading, VeinViewer® Vision2 and Flex systems, are near-infrared, vascular imaging devices that allow clinicians to clearly see accessible vasculature as a real-time HD image, projected directly on the surface of the patient's skin. Since its invention, VeinViewer has transformed over the years into the current innovative models found in over 50 countries to accurately and safely illuminate veins up to 10 mm deep. It is the only vein finder of its kind that can positively impact the entire Pre-, During- and Post-access procedure through proven clinical and cost-saving results.

Read More

MEDTECH

BIO-ISAC and New York Metro InfraGard Membership Alliance Announce Partnership

NY Metro InfraGard | April 28, 2022

The Bioeconomy Information Sharing and Analysis Center (BIO-ISAC) and New York Metro InfraGard Members Alliance® (NYM-IMA) today announced a partnership to address threats unique to the bioeconomy and enable coordination among stakeholders to facilitate a robust and secure industry. BIO-ISAC is a critical resource for cyber threat detection, prevention, protection, response, recovery and resilience in the bioeconomy. It helps spur the development and evaluation of defensive tools to address ongoing and emerging threats, and includes vulnerability identification and mitigation, and education and outreach, aimed at reducing risk to the nation's biosecurity infrastructure. BIO-ISAC partnering with NYM-IMA advances our efforts to strengthen our resilience from attacks on the public and private bioeconomy infrastructure. We look forward to developing our collaboration to further enhance, maintain and implement best practices and standards to improve global digital biosecurity." Nina Alli, board member of BIO-ISAC. The bioeconomy is defined as economic activity driven by research and innovation in the life sciences and biotechnology and enabled by technological advances in engineering and in computing and information sciences. A National Academies of Sciences, Engineering, and Medicine report published in 2020 values the bioeconomy at more than 5 percent of U.S. gross domestic product, or more than $950 billion.* The digitization of life sciences has resulted in the emergence of a complex ecosystem plagued with cybersecurity challenges. We are privileged to collaborate with the BIO-ISAC, a team of exceptionally talented technologists. We support their efforts and share their commitment to safeguarding the cybersecurity of the bioeconomy. To protect our bioeconomy adequately, we must constantly assess the current threat landscape and our response capabilities. This collaboration broadens our aperture, and we believe it will have a significant impact." Jennifer Gold, president, NY Metro InfraGard. The bioeconomy spans multiple U.S. Critical Infrastructure sectors, including Health Care and Public Health, Critical Manufacturing, Food and Agriculture, Chemical, Energy, Government Facilities, Information Technology, Water and Wastewater, and the Defense Industrial Base Sectors. BIO-ISAC members are bioeconomy-connected industry leaders, organizations, and academic institutions connected to Biomanufacturing, BioPharma, BioProducts (synthetic bio), software and hardware vendors, national security, and agriculture. BIO-ISAC also acts as the convening place for trusted international partners to collaborate on digital biosecurity and biological supply chain security issues. InfraGard is a partnership between the Federal Bureau of Investigation (FBI) and members of the private sector for the protection of U.S. Critical Infrastructure. Through seamless collaboration, InfraGard connects owners and operators within critical infrastructure to the FBI, to provide education, information sharing, networking, and workshops on emerging technologies and threats. InfraGard's membership includes business executives, entrepreneurs, lawyers, security personnel, military and government officials, IT professionals, academia and state and local law enforcement—all dedicated to contributing industry-specific insight and advancing national security.

Read More

INDUSTRIAL IMPACT

c-LEcta Announces That It Has Reached Agreement to Be Acquired by Kerry Group

c-LEcta | February 16, 2022

c-LEcta, a leading biotechnology company in enzyme engineering and bioprocess development, has announced that it has reached an agreement with Kerry Group for it to acquire a majority shareholding of the company. Kerry is a world-leading taste and nutrition partner for the food, beverage, and pharmaceutical markets. This strategically compelling combination will accelerate Kerry’s innovation capabilities in enzyme engineering, fermentation and bio-process development while also enabling c-LEcta to fufill its long term growth potential. “We are very happy to join Kerry group and their global presence in the food and pharmaceutical sectors gives us access to additional markets. At the same time, their expertise in ingredient technologies and applications is a perfect fit as we continue to drive our growth potential in the future. We will continue to collaborate with our existing industry partners and will of course continue to produce and distribute our products for our valued customers.” Dr Marc Struhalla, founder and CEO of c-LEcta Thomas Pfaadt, CFO of c-LEcta adds: “We want to thank our previous investors for the great cooperation over the past years. Without their contribution, such a development would not have been possible. Together, we have achieved a lot and we are thankful for their support.” Commenting on the agreement with c-LEcta, Dr Albert McQuaid, Chief Science and Technology Officer of Kerry, said: “The food and pharmaceutical industries are on the cusp of a new wave of innovation where new developments in biotechnology, synthetic biology and precision fermentation are radically transforming these sectors. c-LEcta is a leader in these new technologies, which includes fermentation-based products such as disruptive new enzymes, and the strategically compelling combination with Kerry will accelerate our innovation capabilities in enzyme engineering, fermentation and bio-process development. Our broad market reach across food and pharma markets, combined with our deep enzyme applications expertise and integrated ingredient technology design, will enable and accelerate the growth potential of c-LEcta’s strong portfolio and technology capabilities while also supporting us in the creation of tastier, more sustainable and healthier products.” About c-LEcta c-LEcta is a leading biotechnology company located in Leipzig, Germany. The company has established itself as a leading player in the realisation of high-value biotechnology products for regulated markets, either as in-house development or in close cooperation with the industry. c-LEcta innovation capability delivers cost-efficient and sustainable production processes, creating growth opportunities across existing and new markets. About the Kerry Group Kerry is a world-leading taste and nutrition partner for the food, beverage, and pharmaceutical markets and with its broad portfolio of ingredient solutions reaches more than one billion customers worldwide. Together with their customers, Kerry develops innovative products with great taste, improved nutritional value, and higher functionality, while having a better impact on the environment. Thanks to their leading consumer knowledge, their global RD&A team with more than 1,100 food scientists, and their comprehensive, global presence, Kerry can overcome the complex challenges of their customers with differentiated solutions. Kerry is willing to be a valued partner for their customers and to create a world of sustainable nutrition.

Read More

Spotlight

Pharma IQ has created an easy-to-digest overview of biomanufacturing activity and spend around the world, whether they are already being implemented or have plans in the near future. You’ll be able to keep it as a handy reference, share it around your colleagues or even stick it on your wall.

Resources