Overcome development and manufacturing obstacles for gene therapy commercial success
Gene therapy brings life-changing medicines to patients and even the hope of a cure to those with chronic illness, but the patient-specific nature and different operational requirements compared to traditional biologics create challenges in the transition to commercial viability. Process development and commercialization obstacles must be overcome quickly. Fast optimization of scalable viral vector processes to meet the demands of clinical approvals and commercial cGMP manufacturing is needed to keep pace with rapid movement in the clinical landscape.
At Pall, we understand the uphill battle you are facing to deliver a robust, reproducible and scalable gene therapy viral vector process. We have the proven scalable technology, end-to-end integrated platforms, knowledge and services to help you get your gene therapy to market. Work with us to increase your speed to commercialization or to improve process productivity and deliver therapies to transform lives.
In 2019, Zolgensma, an AAV-based viral vector gene therapy used in the treatment of spinal muscular atrophy was approved by the FDA and our iCELLis® fixed-bed bioreactor was used in the production. Zolgensma’s journey began at the Center for Gene Therapy at The Abigail Wexner Research Institute of Nationwide Children’s Hospital and eventually made its way to Novartis.
Together, we can rapidly optimize your process, whether to prove readiness for industrial scale production or to increase capacity.
We can help you through your gene therapy development journey:
End-to-end integrated platform solutions for fast capacity expansion, including comprehensive package for operator training and regulatory support.
Process development and optimization studies using a wide range of robust, scalable upstream and downstream solutions; and the technical knowledge and experience to support each step of the entire process.
Bench-scale and translational development work to test and implement the best solutions for your process early-on, to increase your chance for success.