Cell and Gene Therapy CDMO Facility: Keele, UK

GI Partners Acquires CDMO and Cell Solutions
As Rose BioSolutions, the established CDMO and Cell Solutions businesses continue to support the biotechnology ecosystem with cell sourcing capabilities and CDMO services to accelerate your advanced therapy from development to delivery.
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Keele Plasmid DNA CDMO Facility Overview

In addition to GMP and non-GMP (research grade) plasmid DNA, we supply High Quality (HQ) plasmid which, manufactured according to the principles of GMP, offers a phase-appropriate solution for early phase clinical trials without compromising quality standards.

• Cobra Biologics (Keele) was founded in 1992
• Acquired in 2021 by Charles River

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Keele Overview

Dedicated Plasmid Manufacturing Facility

• Established Contract Development and Manufacturing Organization (CDMO)
• Cobra Biologics (Keele) was founded in 1992 and acquired in 2021 by Charles River
• 20+ years with an investigational medicinal products (IMP) production license
• 10+ ISO 7 Grade C production suites in two manufacturing areas
• Keele Science Park manufacturing facility: 15,000+ square feet/1,400+ square meters
• Warehouse: 3,229+ square feet/300+ square meters
• 110+ employees

Compliance, Certifications, Accreditations, and Affiliations

Our Keele facility operates in compliance with the following regulatory agencies or accredited organizations:

• Medicines and Healthcare products Regulatory Agency (MHRA) approved for Investigational Medicinal Products (IMP) production
• Good Manufacturing Practice (GMP)

Keele CDMO Facility Service Areas/Study Types

Our plasmid DNA CDMO facility supports developers with the following services:

• Microbial cell banking
• Fit-for-purpose plasmid DNA  process development and manufacturing reinforced by the eXpDNA™ plasmid production platform
  • Research grade plasmid DNA
  • High Quality (HQ) plasmid DNA
  • GMP plasmid DNA
• Linearization
• Analytical testing
• Stability studies
• Fill finish
• Off-the-shelf plasmid products

Microbial Cell Bank Testing Services

To support microbial cell bank testing, we offer the following services:

• Microbial cell bank testing services
  • Cell function
    • Viability
    • Colony morphology
  • Purity
    • Total plasmid
    • Total nucleic acid concentration
    • % supercoiled DNA
  • Identity
    • Confirmation of species, strain (via phenotyping), and plasmid encoded drug resistance (plasmid retention)
    • Restriction digest (plasmid identity)
    • Plasmid genetic stability
    • Plasmid DNA sequencing
    • Plasmid copy number
  • Impurities
    • Bacteriophage
  • Microbiology
    • Gram stain

Plasmid DNA Testing Services

Our team supports developers with the following testing services, which vary by service offering:

• Purity
  • Total plasmid
  • Total nucleic acid concentration
  • % supercoiled DNA
• Identity
  • Restriction digest
  • Plasmid DNA sequencing
• Impurities
  • Residual host cell protein
  • Residual host cell DNA
  • Residual host cell RNA
  • Residual Kanamycin
• Microbiology
  • Bioburden
  • Endotoxin
• Physiochemical testing
  • Osmolality
  • pH
  • Appearance/visual inspection
• Potency (client specific)

Accelerate Your Program

Your Guide to Plasmid DNA from Concept to Cure
Explore the challenges and considerations for plasmid DNA throughout the course of cell and gene therapy development, from plasmid selection in drug discovery, navigating the translation to clinic to future-proof your plasmid products, and finally taking your advanced therapy to commercial.
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