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SIRION Biotech

Scientist on May 14, 2021

This installment of Supplier Spotlight® is on SIRION Biotech, who designs and manufactures viral vectors for cell and gene therapy research and preclinical development.

What is your company’s mission?

SIRION Biotech’s mission is to enable cell and gene therapy companies to get the most effective treatments to patients as quickly and efficiently as possible. We are committed to improving the quality and effectiveness of viral vectors by working intensively on developing our quality and controls, upscaling our processes and capsid evolution. Our Discovery and PreClinical Services team manages viral vector development and manufacturing, our Cell and Gene Therapy Clinical Support team helps our customers through the technical and regulatory frameworks for viral vector therapies and our GMP Alliances team work on the seamless transfer of protocols from our lab to a CDMO.

What products and services do you offer?

We offer engineering and the manufacture of Adeno-Associated Virus (AAV), Lentivirus and Adenovirus particles for research and preclinical studies. We are experts in developing vectors to meet the exacting needs of our clients – from optimizing vector constructs to limit impurities and maximize expression to evolving new capsid forms to enhance tropism and reduce immunogenicity. We also have a range of proprietary BOOST Transduction Enhancers. Our proprietary LentiBOOST® lentiviral transduction enhancer is highly effective for therapeutic cell types like CAR-T cells and CD34+ hematopoietic stem cells. LentiBOOST® is currently included in more than 20 Phase III and I/II clinical trials.

What problems does your organization solve?

We support our clients in creating the best vector for their needs. Many cell and gene therapies fail at the regulatory stage due to problems that could have been resolved very early on with an optimized vector construct. Our Cell & Gene Therapy Clinical Support Department works closely with clients to make sure that the vectors they are developing are optimized for their application and meet the required FDA and EMA standards. Large scale viral vector manufacture is a major cost factor for cell and gene therapies, so Transduction Enhancers such as LentiBOOST®, which reduce the amount of therapeutic vector needed, are essential to reduce cost and increase safety.

What are the most innovative tools and technologies that you offer?

Our AAV Evolution program in collaboration with Professor Dirk Grimm at Heidelberg University Hospital optimizes AAV capsids using directed evolution via peptide insertion and shuffled AAV libraries. DNA family shuffling followed by DNA-barcoding for in vivo screening is at the center of this research. Once improved AAV vectors have been identified, we can further optimize the expression cassette and vector design for improving gene expression and production yields, as well as reducing impurities.

What are your competitive advantages?

We have a highly qualified, experienced team working on each project. Our Project Team are experts in viral vector engineering to maximize expression and reduce the level of incomplete genomes and co-purified plasmid fragments and can work with clients at a very early stage to ensure their vectors meet regulatory requirements. Ongoing upstream and downstream process development means we are well equipped to efficiently manufacture viral vectors from research to preclinical stages. Our dedicated Project Developers work closely with clients to ensure that we meet their needs, from small scale manufacturing up to major development projects.

Who are your clients?

Our more than 300 clients are researchers and drug developers in fields of cell and gene therapy, drug discovery and analytical development in organizations ranging from academia to small biotechs and global pharmaceutical companies. We have completed over 3,000 projects across our 3 viral vector technology platforms. LentiBOOST® clients are both at a stage of cell therapy research and development, as well as already performing clinical studies. GMP-grade product is licensed for commercial use but is royalty-free for research hospitals. This primarily helps patients and at the same time enables us to further spread the use of this innovative technology.

What new products and services are you developing in 2021?

We are currently beta-testing a state-of-the-art Lentivirus purification protocol and constantly improving our upstream and downstream processes. We expand our Quality Control portfolio to ensure the highest quality of our vectors and increase our production capacities.

Where are your laboratories and offices located?

Our laboratories are located in Martinsried, near Munich in Germany, and we will be moving to a new and larger facility nearby in 2022. We also have laboratory facilities in Heidelberg. We have sales staff covering our global customer base located in offices in Munich, Boston and Paris, with agents representing us in Korea, Israel and Tokyo. In Munich alone, we have 9 different nationalities on staff!

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