Repligen is ready to partner with gene therapy developers and manufacturers, providing technology breakthroughs and high impact solutions for plasmid and viral vector manufacturing.
Repligen solutions from gene to therapy
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.
Leading Gene Therapy Manufacturing 2.0
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.
Repligen is a technology and market leader in gene therapy applications
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
Offering workflow solutions uniquely fit for gene therapy
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
Workflow solutions for gene therapy
Needs and challenges:
- Automated operations, standardized hardware platforms
- Single-use technologies to ensure closed system bioprocessing and eliminate cross-contamination risk
- Process modernization/optimization to increase product yield, product quality
- Robust analytical tools to normalize inherent assay variability
REPLIGEN technical support ENSUres Success
Repligen Field Application Specialists (FAS) with expertise in Gene Therapy provide support from consultation to implementation globally.
Consultation
- Theory
- Technology fit
- Experimental plan
Evaluation
- Demonstration
- Training
- Data analysis
Development
- Optimization
- Flow Path sizing
- System sizing
Implementation
- Scale-up
- Validation
- Long-term training plan
Resources
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
Viral Vector and Plasmid Quantitation Analytics for Accelerated Gene Therapy Time to Market
August 21, 2020
Technology-ready processes for Gene Therapy Manufacturing 2.0
May 12, 2020
Automated High Throughput Viral Vector Purification to Streamline Downstream Process Development in Gene Therapy
May 12, 2020
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.
Repligen Corporation
Homology, Medicines Inc.
July 2020