The gene therapy clinical pipeline continues to be in a growth phase, with over 2,000 therapies in development globally, with recombinant adeno-associated viral vectors (rAAV) as one of the most powerful tools for gene delivery to treat human disease, leading the way.
The manufacture of rAAV continues to be challenged to incorporate faster, safer, scalable and cheaper critical starting material and manufacturing processes to meet timelines and regulatory demands. TAAV-manufactured enzymatic DNA, a novel enzymatic DNA technology, is a good critical starting material for rAAV production that can support the demands in the rapidly evolving gene therapy field and addresses the current challenges faced in rAAV manufacture.
In this webinar, the featured speakers will present the TAAV-manufactured enzymatic DNA process and product, featuring the advantages of the technology, such as regulatory benefits of using a bacterial-free DNA vector, leading to a more efficient and robust production. The speakers will discuss the quality control and assurance system that enables TAAV to provide a high quality product that can support an efficient rAAV manufacturing throughout process all phases of development from preclinical to clinical.
Join the featured experts to learn more about achieving a robust, scalable and high-quality DNA supply in recombinant adeno-associated viral vector gene therapy manufacturing.
1 TAAV-manufactured enzymatic DNA technology is licensed from Touchlight UK.
Speakers
Dr. Leticia Agúndez, R&D Senior Manager, TAAV Biomanufacturing Solutions
Leticia Agúndez graduated with a bachelor’s degree in biochemistry from the University of the Basque Country (Spain) and obtained a PhD in molecular microbiology from the University of Cantabria (Spain). During her postdoctoral research work at King’s College London (KCL), she focused her studies on AAV biology. Later, at University College London (UCL), she worked on gene editing and gene and cell therapies for the treatment of retinal disorders. With more than 15 years of experience in basic and translational research, she is an expert in the fields of molecular biology, AAV and gene therapies. Since August 2019, Leticia has led the R&D department at TAAV.
Message Presenter
Lucía San Miguel, Quality Senior Manager, TAAV Biomanufacturing Solutions
Lucía San Miguel graduated in pharmacy and has a master’s degree in research, development and innovation of medicines from the University of Navarra (Spain). She serves as Quality Senior Manager at TAAV since 2019. Prior to joining TAAV, she worked for 11 years at 3P Biopharmaceuticals in quality assurance and quality control fields, including positions as Analytical Services Director and Qualified Person. She has expertise in the implementation and maintenance of quality management systems, in GMP regulations, in the design, construction and qualification of biotechnology companies, as well as in the management of human teams and resources.
Message PresenterWho Should Attend?
Companies working on AAV manufacturing and key decision makers for process development or new technology evaluation. Job roles include:
- Gene Therapy Professionals
- Process Development Scientists
- Quality Professionals
- Research Scientists
- Laboratory Technician/Analysts
- QC Analysts
- Scientists working within viral vector manufacturing
What You Will Learn
Attendees will gain insights into:
- A synthetically manufactured DNA to produce double stranded linear molecules with covalently closed ends
- The many advantages of an enzymatic DNA technology over plasmid for the manufacturing of recombinant adeno-associated viral vector (rAAV) — quality of the material, elimination of bacterial sequences, amplification of difficult sequences including ITRs, lower amounts of DNA required for transfection and a scalable process to meet the DNA needs of any AAV manufacturing program
- Availability of R&D, preclinical and clinical (GMP-compliant) grades of the synthetic DNA for different stages in rAAV gene therapy programs
- Usage of this enzymatic DNA technology in Phase I/II
Xtalks Partner
TAAV Biomanufacturing Solutions
TAAV Biomanufacturing Solutions, S.L. (TAAV) is a cGMP manufacturer of TAAV-manufactured enzymatic DNA, a synthetic DNA material used for adeno associated virus (AAV) gene therapies. The company is an independently operated, wholly owned subsidiary of Asklepios BioPharmaceuticals (AskBio) and, AskBio is an independent, wholly owned subsidiary of Bayer AG. TAAV-manufactured enzymatic DNA is manufactured using an enzymatic process and produced under ISO classified production suites following GMP standards for research, clinical and commercial applications of synthetic DNA in AAV therapeutic vectors. Synthetic TAAV-manufactured enzymatic DNA is an alternative to plasmid DNA, commonly used in AAV manufacturing, and leads to higher yields of DNA material. The use of synthetic TAAV-manufactured enzymatic DNA material can significantly shorten manufacturing timelines and facilitate faster production of AAV with an increased safety profile by eliminating residual bacterial sequences of plasmid DNA in the AAV product. TAAV was founded in 2019 and became 100% wholly owned by AskBio in 2022. Company headquarters, manufacturing facilities and labs are in San Sebastian, Spain. For more information, go to taav.com.
1TAAV-manufactured enzymatic DNA is a trademark of Touchlight Genetics Limited. Technology for making TAAV-manufactured enzymatic DNA is licensed from Touchlight IP Ltd
Related Webinars
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account