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: 

 

 

Bench-scale and translational development work to test and implement the best solutions for your process early-on, to increase your chance for success.

 

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.

 

End-to-end integrated platform solutions for fast capacity expansion, including comprehensive package for operator training and regulatory support.

Latest News

RD-Biotech Partners With Pall Corporation to Plan for the Future of pDNA Production and Supply

May 18, 2022: RD-Biotech, a Contract Research Organization (CRO) specializing in the production of plasmid DNA (pDNA) for early-phase clinical trials, has partnered with Pall Corporation to supply single-use solutions and purification technology to support the manufacture of industrially-relevant volumes of GMP-grade pDNA.
May 18, 2022: RD-Biotech, a Contract Research Organization (CRO) specializing in the production of plasmid DNA (pDNA) for early-phase clinical trials, has partnered with Pall Corporation to supply single-use solutions and purification technology to support the manufacture of industrially-relevant volumes of GMP-grade pDNA.
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Pall's iCELLis® Nano Bioreactor Helps IBIS Develop its GMP Viral Vector Production Capability to Support CAR-T Therapy Trials

May 16, 2022: The Institute of Biomedicine of Seville (IBIS) is a multidisciplinary biomedical research center that plan to develop and rapidly transfer process knowledge into the clinic setting with support from the European Infrastructure for Translational Medicine (EATRIS).
May 16, 2022: The Institute of Biomedicine of Seville (IBIS) is a multidisciplinary biomedical research center that plan to develop and rapidly transfer process knowledge into the clinic setting with support from the European Infrastructure for Translational Medicine (EATRIS).
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Yposkesi Scale Up to Deliver a Suspension Viral Vector Production Platform

May 11, 2022: Yposkesi, a SK pharmteco company, is a CDMO specializing in the development and manufacture of cell and gene therapies, which are experiencing growth in the demand for viral vector production every day.
May 11, 2022: Yposkesi, a SK pharmteco company, is a CDMO specializing in the development and manufacture of cell and gene therapies, which are experiencing growth in the demand for viral vector production every day.
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VectorBuilder and Pall Establish Viral Vector Process Optimization Center

February 9, 2022: VectorBuilder Inc. and Pall Corporation recently held a signing ceremony in VectorBuilder’s GMP manufacturing facility in Guangzhou, China to officially launch a strategic partnership. VectorBuilder and Pall Corporation will jointly set up the VectorBuilder-Pall Center for Gene Delivery Technologies.
February 9, 2022: VectorBuilder Inc. and Pall Corporation recently held a signing ceremony in VectorBuilder’s GMP manufacturing facility in Guangzhou, China to officially launch a strategic partnership. VectorBuilder and Pall Corporation will jointly set up the VectorBuilder-Pall Center for Gene Delivery Technologies.
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Pall Provides Scalable Manufacturing Technology to Swiss Training Center to Support Gene Therapy Manufacturing Upskilling in Europe

July 22, 2021: The continuing growth of gene therapies and genetic vaccines, and the processes that manufacture them at all scales, continues to highlight the need for scalable manufacturing solutions and the expertise to develop and run these processes.
July 22, 2021: The continuing growth of gene therapies and genetic vaccines, and the processes that manufacture them at all scales, continues to highlight the need for scalable manufacturing solutions and the expertise to develop and run these processes.
Read more