Through cell line development and process development, our production platform reaches the high level of production yield among those reported in the AAV industry. The high yield leads to low manufacturing cost, and competitive drug pricing to benefit patients and payors across the world.
Our production platform produces high percentage of full AAV vectors containing the therapeutic DNA, and thus reduces the generation of empty capsids. In addition, our platform produces AAVs with low DNA impurities and low protein impurities. The high level of empty capsids, and/or the high impurity DNA or proteins, in an AAV drug are likely associated with reported Serious Adverse Event (SAE) in various AAV clinical trials. With the high AAV purity, we improve the drug safety profile.
Our process is reproducible at different scales from 2L to 500L in single-use bioreactors. The lower levels of empty capsids produced in our upstream process enables all downstream purification steps to be scalable and removes bottlenecks (e.g. ultracentrifugation) present in other production systems. The good scalability shortens the development time from research to manufacturing, and removes uncertainty of the AAV productivity in the program planning and execution.
Frontera Therapeutics was founded in September 2019. The company brings together biotech leaders with extensive experience in innovative gene therapy research and development, clinical research, manufacturing, registration and commercialization in both China and the United States. Frontera is committed to developing and manufacturing high-quality, affordable AAV gene therapy products to meet the unmet needs of patients worldwide suffering from rare and chronic genetic diseases.
Company Mission: Develop and manufacture high-quality gene therapy products that are affordable to patients worldwide.
Company vision: Aspire to become a leading gene therapy company that patients trust, respected by peer companies, and is recognized by the communities.
Core values: Innovation, Efficiency, Integrity, Rigor.
Thanks to a strong R&D team, Frontera completed strategic product deployment that covers four key therapeutic areas of rare and chronic diseases. New product is being added to the pipeline based on newest scientific advancement. The most advanced programs are in the pre-clinical development.