BARCELONA, Spain — September 15, 2022- Veeva Systems (NYSE: VEEV) today announced Batavia Biosciences selected Veeva Vault Quality Suite to optimize its global quality assurance (QA), unifying content, processes, and training management on a single platform. Batavia will also benefit from real-time insights that support ongoing QA improvements and inspection readiness.
“As our development footprint grew globally, we needed to optimize our QA approach to better meet future needs,” said Jolanda Van Vliet, director of quality assurance, Batavia Biosciences. “Bringing our QA onto Veeva’s cloud-based platform enables us to centrally manage quality documentation and training, facilitate collaboration among authors, and improve reaction time to quality events.”
Based in the Netherlands, Batavia Biosciences is a full-service contract development and manufacturing organization (CDMO) specializing in viral vaccines, virotherapy, and protein vaccines. With Veeva Vault QMS, Batavia can centrally manage QA processes to better ensure GxP compliance, while Veeva Vault QualityDocs automates workflows and audit trails, simplifying document management, updates, and review processes. Veeva Vault Training will further help the CDMO ensure role-based qualifications.
“It is a privilege to partner with Batavia to support their launch of a fully digital quality assurance system and boost inspection readiness,” said Sofia Lange, director strategy, Vault Quality & Manufacturing at Veeva. “With the addition of Vault Quality Suite, Batavia now has a scalable foundation that will strengthen its QA processes and oversight across operations.”
For more on Veeva Vault Quality Suite, visit: veeva.com/VaultQuality
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About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com/eu.
There are still many challenges in gene therapy analytics and manufacturing according to gene therapy developers. Our Global Technical Director, Alfred Luitjens was interviewed on this topic by Genetic Engineering & Biotechnology News. The interview was in response to his presentation on the manufacturing of a lentiviral vector for a gene therapy against RAG1-SCID at the PepTalk conference 2020.
Link to full article.
Several virus types have been studied for use as viral vectors in gene therapy, including adenovirus, lentivirus, retrovirus, and adeno-associated virus (AAV). All platforms have their own advantages over one of the others. The recent successes with AAV and lentivirus give these vectors a boost in development. In combination with the fact that they are well studied, might make them the frontrunner for some therapeutic applications. Our Technical Lead, Kai Touw, has been interviewed by BioPharm International to discuss the potential and challenges of viral vector production for gene therapy.
Link to full article.
With Ron van Eijsden heading the Sales and Business Development team, Batavia expands its Management Team and reinforces its sales activities to support the ambitious expansion plans.
In 2021, Batavia successfully doubled its viral vector process development capacities in Woburn, MA, USA. This year, Batavia will double its infrastructure in Leiden, the Netherlands, to support the growing demand for process development and analytical capabilities in pursuit of viral vaccines and viral vector-based products. As part of its ambition, Batavia also started preparations to build a clinical and commercial manufacturing facility in Leiden, to support its clients. With these expansions, Batavia will offer end-to-end development and manufacturing support to its customers thus living up to its vision in helping to reduce human suffering from infectious diseases and cancer.
Ron van Eijsden commented: “I am excited to be part of the Center of Excellence CDMO Batavia and working to improve the affordability and availability of innovative and life-saving biopharmaceuticals. We work for some of the most exciting biopharma companies, academia, charity organizations and governmental organizations at the forefront of biopharmaceutical development. In my role as head of Business Development I can seamlessly combine my passion for networking and business development whilst making an impact on Global Health and bringing medicines to patients faster. I like that, at Batavia, it is not only about executing what our customers ask for, but about being a thought partner in designing the most optimal development roadmap”.
Ron has a PhD in molecular biology and an extensive career in business development within the red biotech industry. Prior to joining Batavia, Ron has worked in a variety of senior roles in various biopharmaceutical and biotech companies, including DCPrime, Pepscope, HAL Allergy, Catalyst Clinical Research, Linical Accelovance and Medelis Europe.
Leiden, The Netherlands, June 14, 2022 – Today, Batavia Biosciences announces the expansion of its headquarters and R&D capacities in the Netherlands. The infrastructure increases capacity with another 22,500 sq. ft., firmly demonstrating the company’s commitment to act as pacemakers within the rapidly growing biopharmaceutical market.
The expansion allows the company to increase its R&D activities for viral vector-based product development including Lentivirus, AAV, Adenovirus, and Measles virus vectors. In addition, the increased R&D infrastructure helps to meet increased global demand for vaccine development, be it live-attenuated, whole killed, vectored, or subunit vaccines. The expansion will be finalized by June 2023.
Menzo Havenga, CEO of Batavia Biosciences, states, “At Batavia, we are reminded daily of the urgency of bringing medicines to patients in need. With this infrastructure expansion, our contribution of award-winning process development and clinical manufacturing of vaccines and vector-based products can continue its ascent to new heights. No doubt this will further enable us getting the necessary medicines and therapies into the patients’ hands faster and make them more affordable.”
Chris Yallop, CSO at Batavia Biosciences, adds, “The new laboratory floor space for R&D and analytical capabilities will aid the development capacity for customer projects. The increased allocation for R&D capacity better positions Batavia Biosciences to serve as pacemakers to the community and to continue to bring promising candidate biopharmaceuticals from bench to clinic.”
Washington, April 20, 2022 – Batavia Biosciences was honored this week during the Vaccine Industry Excellence (ViE) Awards show at the World Vaccine Congress with the award for Best Production/Process Development. The ViE Awards provide a time and place to celebrate the industry’s most outstanding achievements showcasing excellence in the global vaccine industry. Being recognized for the award is affirmation and a testament to the employees incredible work at Batavia. Helping to reduce human suffering and provide affordable and equitable access of vaccines to everyone has been and will continue to be our goal.
Judges at the ViE Awards evaluated Batavia and other shortlisted competitors looking for evidence and examples around 5 major areas:
- Demonstration of ongoing commitment to provide production technology globally and reducing lead times for its customers
- Demonstration of end-to-end suite solutions to customers
- Demonstration of outstanding thought leadership and spearheading innovation
- Raising the bar on process standards
- Demonstration of quality of relationships with clients
Batavia was able to provide sound evidence for each category and take home the prestigious award. Batavia is a Center of Excellence CDMO and next to providing high quality services, we provide thought partnership, share best practices, perform research, and provide support.
Menzo Havenga, CEO Batavia Biosciences, says: “I am proud of what we have achieved with Batavia in the past 12 years. This award is a great recognition for our efforts to make vaccine manufacturing more affordable to support accessibility for all in need.”
We would also like to congratulate other shortlisted candidates for the Best Productions/Process Development award; Moderna, LumaCyte, Millipore Sigma, Sartorius Stedim Biotech, BD Medical, Pharmaceutical Systems, and Eppendorf.