Catalent, Inc products

Antibody-drug conjugates (ADCs) combine the targeted binding specificity and pharmacological advantages of monoclonal antibodies with the potency advantages of small molecule chemotherapy agents via conjugation with chemical linkers.  With 10 approved products and a large and growing list of programs in clinical and pre-clinical development, ADCs and other bioconjugates are emerging as one of the fastest-growing development areas in biologic anti-cancer treatment and beyond.

AAV, or adeno-associated virus, is considered the gold standard for in vivo gene delivery transfer and has become the leading viral vector choice for gene therapies today. As one of the field’s most effective delivery tools, AAV has shown strong clinical success and recent improvements in related technology and system approaches have made AAV production an efficient means to meet clinical and commercial requirements.

AAV, or adeno-associated virus, is considered the gold standard for in vivo gene delivery transfer and has become the leading viral vector choice for gene therapies today. As one of the field’s most effective delivery tools, AAV has shown strong clinical success and recent improvements in related technology and system approaches have made AAV production an efficient means to meet clinical and commercial requirements. Catalent Cell & Gene Therapy is a leading expert in producing all AAV vectors across multiple serotypes (1, 2, 5, 6, 8, 9, 10) and has proven experience in triple transfection in both adherent and suspension cell cultures. We are ready to partner with you to develop the optimal growth conditions for your AAV program. For partners looking to accelerate their speed to the clinic, Catalent offers the UpTempo Virtuoso™ AAV platform process.

Catalent Biologics’ drug substance development and manufacturing services leverage advanced technology and proven expertise to help clients meet their biologics drug substance needs. Our development teams collaborate closely with our bioanalytical testing and manufacturing teams to ensure that processes and products are scalable to clinical and commercial scale. Catalent’s cell line development technology, GPEx®, produces high-performance, highly stable, production cell lines in a wide variety of mammalian host cells. Whether you utilize our cell line development technology or develop your cell lines in house, our process development services ensure consistent CGMP manufacturing performance and a reliable product supply.

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.

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.