Gene Therapy has immense potential to transform the lives of patients with genetic diseases. As demand for plasmids and viral vectors outpace capacity, a greater than 10-fold and potentially close to 100-fold increase in manufacturing efficiency for the gene therapy reagents is likely required to meet a demand curve that is increasing exponentially. Repligen solutions aim to meet the needs for optimized processes, higher yields, and improved process quality - setting new standards for modern scalable processes from gene to therapy.
Repligen is in a unique position to lead Gene Therapy Manufacturing 2.0, where the viral vectors will be continuously produced from producer cells, using intensified suspension cell culture ran in perfusion mode, and purified through a secured and high efficiency downstream process.
Broad customer base including pre-clinical to Phase III candidates, CDMOs, therapy developers, academic/hospitals
Adoption in diverse technology platforms including plasmids, AAV, Lentivirus, mRNA, CRISPR, CAR-T
Novel solutions for upstream process intensification, downstream processing for plasmids, viral and non-viral vectors
Closed system bioprocessing – single-use, Gamma-irradiated, fully integrated flow paths
Scalable platforms supporting benchtop process development to production scale manufacturing
Dedication to Quality – ISO 9001:2015 manufacturing
Needs and challenges:
Repligen Field Application Specialists (FAS) with expertise in Gene Therapy provide support from consultation to implementation globally.
Lentiviral vector manufacturing process enchancement utilizing TFDF™ technology
by Thomas Williams, Oliver Goodyear, Lee Davies, Carol Knevelman, Michael Bransby, Kyriacos Mitrophanous and James Miskin
Cell and Gene Therapy Insights, April 2020
Gene Therapy Manufacturing 2.0
by René Gantier, PhD, Director of Gene Therapy Technologies, Repligen Corporation
AAV Studies Deploying a Closed, Irradiated, Single-use Flat Sheet TFF Device
by David Bianchi, Carl Breuning, Michael LaBreck, Shelly Parra, Mary Jo Wojtusik, Repligen Corporation
Alex Meola, Michael Mercaldi, Thomas Thiers, Homology, Medicines Inc.
Homology, Medicines Inc.