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Gene Therapy
Integrated Solutions
Gene therapy holds the promise of treating the unmet needs of patients who suffer from a rare genetic disease. An estimated 4,000 medical conditions are a result of gene disorders with no previous targeted treatments. Gene therapy offers new options away from the conventional symptomatic approach to disease treatment as well as provides hope for real cures. At Catalent, we understand the unique and complex nature of bringing a gene therapy to market and are dedicated to achieving the best approach for your product from start to finish. As unique as the therapies themselves, every path from the bench to the clinic is tailored to ensure that your results are timely and efficient. We are here to optimize your plasmid DNA and viral vector development and streamline your manufacturing process for optimal and reliable titers to achieve a stable and effective product dose.
Critical Raw Material for Advanced Therapeutics
Plasmid DNA is a critical raw material for advanced therapeutics including mRNA- and viral vector-based cell and gene therapies and vaccines. To support your therapeutic programs, the Catalent team has broad expertise in developing customized plasmid DNA manufacturing solutions, from plasmid R&D services to large-scale CGMP plasmid production. Catalent can help you with lead identification to support candidate selection and feasibility studies. Once leads are identified, our cell line, process, and quality control assay development services will help assure the plasmids will meet your preferred critical quality attributes.
