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 is a technology and market leader in gene therapy applications
Strong market penetration with ~20% share in Gene Therapy accounts and ~150 customers
Significant technology adoption with ~50 customers at $100K and 8 customers at $1M in annual sales
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
technology-ready 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
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