Plasmid DNA is accepted as a starting material for the production of mRNA or viral vectors such as lentivirus vectors and adeno-associated virus (AAV) vectors.
Repligen solutions for plasmid DNA manufacturing
Needs and challenges
- Process improvements are needed, including closed single-use systems, automated and standardized platforms.
- Capacity has to keep up with increasing demand; facility throughput is important.
- Low shear filtration processes are critical as pDNA becomes concentrated.
Repligen solutions can help overcome obstacles in Plasmid DNA bioprocessing.
Click on the unit operation below to find productivity and throughput solutions you can implement today.
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| ProConnex® Flow Paths |
Spectrum® Hollow Fiber Filters |
KrosFlo® TFF Systems |
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Sterile, disposable, sensor-integrated and ready-to-operate Compatible with hollow fiber and flat sheet filters Ideal for Gene Therapy: aseptic processing, reduced cross-contamination risk |
Wide range of formats, chemistries and pore sizes Ideal for UF/DF of large, shear-sensitive molecules, like Lentivirus - high yield and improved impurity removal in process and/or final purified product formulation |
Fully automated, easy to operate Scalable from bench to production Compatible with hollow fiber and flat sheet TFF Low hold-up volumes |
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|---|---|---|---|---|
| ProConnex® Flow Paths |
Spectrum® Hollow Fiber Filters |
KrosFlo® TFF Systems |
TangenX™ SIUS™ Gamma Flat Sheet Cassettes | SoloVPE™ Analytics |
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Sterile, disposable, sensor-integrated and ready-to-operate Compatible with hollow fiber and flat sheet filters Ideal for Gene Therapy: aseptic processing, reduced cross-contamination risk |
Wide range of formats, chemistries and pore sizes Ideal for UF/DF of large, shear-sensitive molecules, like Lentivirus - high yield and improved impurity removal in process and/or final purified product formulation |
Fully automated, easy to operate Scalable from bench to production Compatible with hollow fiber and flat sheet TFF Low hold-up volumes |
Closed, ready-to-use, single-use cassettes High flux membranes increase yield, reduce process times, promote consistency, minimize costs Ideal for AAV processes where large volumes need to be concentrated 20-60x prior to chromatography |
Rapid and accurate absorbance measurements; Avoid labor-intensive, precision-impacting sample dilution Automated plasmid/viral vector concentration measurement with increased assay variability and repeatability |
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| OPUS® Columns |
SoloVPE™ Analytics |
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Ready-to-use, no packing expertise needed Pack any resin for AAV, Lentivirus, or plasmid purification (including custom resins) 0.5 - 30 cm IDs | 5 - 30 cm bed heights |
Rapid and accurate absorbance measurements; Avoid labor-intensive, precision-impacting sample dilution Automated plasmid/viral vector concentration measurement with increased assay variability and repeatability |
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|
|
|
|
|---|---|---|---|---|
| ProConnex® Flow Paths |
Spectrum® Hollow Fiber Filters |
KrosFlo® TFF Systems |
TangenX™ SIUS™ Gamma Flat Sheet Cassettes | SoloVPE™ Analytics |
|
Sterile, disposable, sensor-integrated and ready-to-operate Compatible with hollow fiber and flat sheet filters Ideal for Gene Therapy: aseptic processing, reduced cross-contamination risk |
Wide range of formats, chemistries and pore sizes Ideal for UF/DF of large, shear-sensitive molecules, like Lentivirus - high yield and improved impurity removal in process and/or final purified product formulation |
Fully automated, easy to operate Scalable from bench to production Compatible with hollow fiber and flat sheet TFF Low hold-up volumes |
Closed, ready-to-use, single-use cassettes High flux membranes increase yield, reduce process times, promote consistency, minimize costs Ideal for AAV processes where large volumes need to be concentrated 20-60x prior to chromatography |
Rapid and accurate absorbance measurements; Avoid labor-intensive, precision-impacting sample dilution Automated plasmid/viral vector concentration measurement with increased assay variability and repeatability |
|
| SoloVPE™ Analytics |
|
Rapid and accurate absorbance measurements; Avoid labor-intensive, precision-impacting sample dilution Automated plasmid/viral vector concentration measurement with increased assay variability and repeatability |
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.
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