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Technology-ready Solutions for Gene Therapy


Repligen is ready to partner with gene therapy developers and manufacturers, providing technology breakthroughs and high impact solutions for plasmid and viral vector manufacturing.

AAV 
Solutions

Lentivirus 
Solutions

Plasmid DNA
Solutions

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.

Virtual seminar | Gene Therapy manufacturing 2.0

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
     

AAV
Solutions

Lentivirus 
Solutions


Plasmid DNA
Solutions

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

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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

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