GMP Biologics Services

The services offered at Ballina range from method development, method transfer and phase-appropriate validation to process/cleaning validation, impurities testing, stability storage and sample analysis.

GMP Quality Control/Routine Testing

Charles River Scientists working in a lab

Charles River provides release testing services for bulk drug substances and clinical and marketed drug products for the European Union (EU), United States (US), and other regulatory-distinct markets, and can act as a single site for your global release testing needs.

  • Analytical Services
    • Compendial methods (USP, EP, or other methodologies upon request)
           ∘ pH
           ∘ Appearance
           ∘ Colors
           ∘ Conductivity
           ∘ Osmolality
           ∘ Moisture (volumetric and coulometric)
           ∘ Sub-visible particles
           ∘ And more...
    • Water testing (USP and EP)
    • SDS-PAGE (Coomassie, silver stain)
    • Western blot
    • Protein concentration (A280, BCA, Bradford, Lowry)
    • Size exclusion (SEC-HPLC)
    • HPLC methods (RP-HPLC, peptide map, IEX)
    • UPLC methods
    • Ion exchange chromatography
    • Capillary electrophoresis to separate proteins by size or by pI
    • ELISA (residual protein A by ProtA ELISA, residual host cell proteins by HCP, ELISA, specific activity)
    • Carbopol concentration
    • Additional wet chemistry techniques
  • Biosafety (In Vivo and In Vitro)
    • Pyrogen/endotoxin testing
           ∘  Rabbit pyrogen testing
           ∘  Monocyte activation test (MAT) cytokines via ELISA
           ∘  LAL (bacterial endotoxins)
                  –   Gel clot
                  –   Turbidimetric
                  –   Chromogenic

    In Vitro and In Vivo Adventitious Agents Testing

    •  In vivo
           ∘  USP, EP, ICHQ5A, and combined method 
           ∘  MAP/HAP/RAP, including LCMV challenge
           ∘  Supply of chicken, turkey, and guinea pig blood
    • In vitro
           ∘  Humans and animal cell lines 
           ∘  Various virus controls
    •  Mycoplasma (USP, EP, or JP)
           ∘ Indicator cell Line method ("non-cultivable" mycoplasma agents [Vero cells])
           ∘ Agar/broth method ("cultivable" mycoplasma species)
  • In Vivo Bioassay
    • Potency
           ∘  Neurotoxin, vaccines, hormone, anti-venom
           ∘  Immunopotency, including ELISA
                  –   Mouse, rat, ferret, cotton rat, hamster, and guinea pig bioassays
                  –   Serum analysed by ELISA on site or at your laboratory
    •  Immunoassays
    •  Primary cell isolation to support immunogenicity studies
           ∘  BioPLEX and ELISpot 
           ∘  ELISA (quantattive and semi-quantative)
           ∘  Western blot
    •  Microplate analysis
           ∘ Protein or carbopol concentration
           ∘ Activity assays
    •  Onsite animal breeding
           ∘ Mouse – CD-1 and MF-1 SPF
           ∘ Ferret – SPF ferret
  • Microbiology Testing
    • Sterility testing (clean room and SKAN isolator)
    • Preservative efficacy testing (PET)
    • Microbial limits (non-sterile products)
    • Bioburden
    • Disinfectant efficacy and validation
    • Microbial analysis of water
    • Microbial challenge and hold time studies
    • Environmental monitoring service and microbial identification
    • Rapid sterility testing (Celsis® Advance II)
    • LAL (bacterial endotoxins)
           ∘  Gel clot
           ∘  Turbidimetric
           ∘  Chromogenic
    • Monocyte activation test (MAT) cytokines via ELISA
    • Biological reactivity/cytotoxicity
           ∘  Mouse fibroblast (in vitro assay)
    • Provide bacteria and fungal inoculum for challenge studies

Stability Studies

Charles River scientist working in a lab, pipetting into a test tube.

Stability studies are an essential part of product development and are conducted throughout a product's life cycle. They are required by a number of regulatory agencies. Our Ballina site offers a comprehensive suite of storage conditions and the necessary testing required to meet regulatory requirements. Our walk-in and reach-in chambers are monitored and controlled 24/7, and each program is defined by a customized stability study protocol based on clients' needs.

  • Stability Storage Conditions
    • ICH conditions
           ∘  -70º C
           ∘  -20 – -25º C
           ∘  2 – 8º C
           ∘  25º C
           ∘  40º C
    • Custom conditions
    • Dedicated storage

Vaccine Testing and Support Services

Assay being auto-pipetted into a well plate

We offer vaccine development services including in vivo disease models for challenge studies, in vivo rodent research models, adjuvant selection studies, and stability assessment of product formulations. The Ballina facility can now perform these services under BSL-2 and BSL-3 standards. The added barriers and constraints will allow us to support GMP-compliant testing of high-risk pathogens like SARS-CoV-2. Our scientists have also supported vaccines including, and not limited to, JEV, Pseudomonas aeruginosa, tetanus toxoid, Equine flu, Diphtheria anti-toxin, Influenza, and Meningitis B, as well as influenza (attenuation, immunogenicity, and anti-sera).

  • Vaccine Development Testing
    • Potency testing (immunopotency)
           ∘  Mouse, rat, ferret, cotton rat, hamster, and guinea pig bioassays
           ∘  Ex vivo supporting assays (R&D and GMP)
                 –    Serum analyzed by ELISA on site or at your laboratory
                 –    Immunocytochemistry
                 –    Histopathology
                 –    Primary cell isolation
    • Challenge studies
    • Adjuvant selection studies
    • Delayed-type hypersensitivity in guinea pigs
    • In vivo influenza vaccine assays
         ∘  Immunogenicity and anti-sera studies in ferrets (R&D)
         ∘  Attenuation/challenge testing in ferrets (R&D and GMP)
         ∘  Ex vivo supporting assays (R&D and GMP)
               –    Hemagglutination (HA)
               –    Hemagglutination inhibition (HAI)
               –    Embryo infectious dose (EID50) using embryonated eggs 
  • Anti-Sera/Polyclonal Ab Production (GMP and R&D Standards)
    • Rodents (rats, mice, cotton rats)
    • Guinea pigs
    • Rabbits
    • Ferrets
    • Large animals (sheep, goats) on request