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Solutions for Plasmid DNA (pDNA) Manufacturing

pDNA.jpg
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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KrosFlo_Pro-Connex.jpg

hf_pardot.jpg KrosFlo-tff-systems.jpg
ProConnex® 
Flow Paths
Spectrum® Hollow
Fiber Filters
KrosFlo® 
TFF Systems

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

 

KrosFlo_Pro-Connex.jpg hf_pardot.jpg KrosFlo-tff-systems.jpg SIUSgamma_Front.jpg SOLO2_1.jpg
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

opus_GT.jpg SOLO2_1.jpg
OPUS®
Columns
SoloVPE™ 
Analytics

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

KrosFlo_Pro-Connex.jpg hf_pardot.jpg KrosFlo-tff-systems.jpg SIUSgamma_Front.jpg SOLO2_1.jpg
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

SOLO2_1.jpg
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.

Virtual seminar | Gene Therapy manufacturing 2.0

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