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Plasmid DNA Manufacturing (pDNA)

25 YEARS OF EXPERIENCE WITH pDNA PROJECTS

Close-up of a DNA double helix

plasmid DNA produced by Richter-Helm:

  • Ready to use RHB-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.

  • Two independent multiproduct GMP facilities
  • Fermenter volumes from 10 - 1,000 L
  • Various pDNA processes and scales available (Proprietary RHB-pART,
    and two different licensed technologies)
  • Tech transfer of external processes possible
  • Additional capacity from mid of 2024 onwards
  • 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

RHB-pART PRODUCTION PROCESS

  • Easy and rapid process scale-up as needed up to 1.000 L
  • Tailor-made solutions for your pDNA project
Contact our experts

KNOW YOUR pDNA MOLECULE

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

Parameter

Suggested Method

  • Identity
  • Restriction analysis
  • Identity
  • Double strand sequencing
  • DNA Concentration
  • UV
  • A260/280
  • UV
  • Purity, Homogeneity
  • CGE
  • Residual Host Cell DNA
  • Q-PCR
  • Residual Host Cell RNA
  • RT-PCR
  • Residual Host Cell Protein
  • ELISA
  • Endotoxin
  • Kinetic-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

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

EXPERTISE

  • More than 30 years of experience in GMP production
  • 25-years 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
  • Extension of capacities for pDNA projects in progress

CUSTOMER SERVICE

  • Project Management
  • Supportive consultancy for pDNA projects

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Product Classes

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Contact Us!

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

contact now

Audits and Accreditations

Contact

Suhrenkamp 59
22335 Hamburg, Germany
Phone: +49 40 55290-801
Fax: +49 40 55290-888

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