Plasmid DNA Manufacturing (pDNA)

Over 35 YEARS OF EXPERIENCE WITH pDNA PROJECTS

Richter BioLogics is a microbial CDMO and produces plasmid DNA in its GMP facilities for over 35 years. With our established ready to use proprietary process pART, we manufacture DNA for a wide range of applications including Cell & Gene Therapy (CGT), DNA Vaccines (API / Drug Substance production), critical raw material (CRM) as starting material for virus production (e.g. Lenti, AAV) or as starting material for mRNA production.

Close-up of a DNA double helix

plasmid DNA produced by Richter BioLogics:

  • Ready to use pART proprietary process
  • Slight process tunings if needed
  • Generic validated QC methods for instant use in place
  • High yields

Plasmid DNA for different purposes:

  • Cell & Gene Therapy
  • DNA Vaccines
  • Starting material for virus production (e.g. Lenti, AAV)
  • Starting material for mRNA production

Plasmid DNA in different qualities and scales:

  • GMP-grade
  • Critical Raw Material (CRM)
  • Active Pharmaceutical Ingredient (API)
  • High Quality-grade
  • Tox material
  • Pre-clinical material
Richter Helm production facility for Plasmid DNA production

PRODUCTION FACILITIES

Flexibility makes the difference.

  • Three independent multiproduct GMP facilities
  • Production capacities 2x 1,500 L & 2x 300L
  • Fermenter working volumes from 10 - 1,500 L
  • Various pDNA processes and scales available (Proprietary pART,
    and two different licensed technologies)
  • Tech transfer of external processes possible
  • Batch scales:
up to
0 g

in 10 L
(non-GMP)

up to
0 g

 in 100 L
(DSP scales from 5 – 20g possible)

up to
0 g

in 1.000 L

  • Cell bank production (RCB and MCB / WCB )
  • High quality with up to 95% supercoiled
  • Technologies and equipment for pDNA manufacturing in various
    scales as required
  • Independent USP and DSP trains
  • Flexible DSP scales / scalable lysis

pART PRODUCTION PROCESS

  • Easy and rapid process scale-up as needed up to 1.500 L
  • Tailor-made solutions for your pDNA project
Contact our experts

KNOW YOUR pDNA MOLECULE

In addition to the methods listed, we provide further assays and custom developed procedures to meet your requirements.

Whether you require pDNA for clinical trial supply or at large-scale and for commercial supply, Richter BioLogics provides you with the most valuable plasmid DNA manufacturing services meeting all your requirements, specifications and timelines.

Parameter

Suggested Method

  • Identity
  • Restriction analysis
  • Identity
  • Double strand sequencing
  • DNA Concentration
  • UV
  • A260/280
  • UV
  • Potency (API)
  • Product-specific methods: e.g. transfection and expression analysis (flow cytometry) and/or functional cell-based assays
  • Purity, Homogeneity
  • CGE
  • Residual Host Cell DNA
  • Q-PCR
  • Residual Host Cell RNA
  • RT-PCR
  • Residual Host Cell Protein
  • ELISA
  • Endotoxin
  • Kinetic-chromogenic LAL
  • Bioburden
  • USP/EP

Documentation delivered

GMP

  • TSE/BSE Certificate
  • Certificate of Analysis (CoA)
  • Certificate of GMP compliance
  • Manufacturing Summary Report
  • Client-Specific Master Batch Records

OUR pDNA SERVICES

GMP

  • Established and validated generic QC testing for pDNA
  • High ratio and maintenance of supercoiled pDNA (≥ 85 - 95 % ccc) *
  • Establishment of reference standards
  • Supportive stability studies
  • Comparability studies
  • Regulatory compliant method transfer if requested
  • Formal stability studies (ICH)
  • Cell bank characterization and stability testing
  • Storage of product according to customer request
  • Release of pDNA material

*Dependent on plasmid and product requirements.

Summary

With a structured and transparent quality approach we produce GMP plasmid DNA in GMP-certified manufacturing suites ensuring the requested quality. Our dedicated project management team guides and supports every client and their products throughout the whole project timeline. Close cooperation and honest partnerships are our claim to provide flexible and transparent services and best in class products.

GMP production expert in lab clothing with production plant in the background

EXPERTISE

  • 35+ year track record in GMP manufacturing of plasmid DNA
  • Trustful and continued customer relationships
  • One-Stop-Shop services for Drug Substance and Drug Product
  • Audited by major authorities including but not limited to FDA, EMA, PMDA

FACILITIES

  • Approved GMP facilities
  • Flexible production capabilities

CUSTOMER SERVICE

  • Project Management
  • Supportive consultancy for pDNA projects

The GMP manufacturing capacity at our three modern facilities ranges from 10 L to 1,500 L and includes end-to-end services along the whole value chain.

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Product Classes

The product types manufactured with microbial expression systems at Richter BioLogics include recombinant proteins and peptides, antibody-like scaffolds (VHH/Nanobodies, Fab-fragments), plasmid DNA, and bacterial vaccines.
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Contact Us!

If you have any questions or suggestions, we will be happy to advise you

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