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Manufacturing

Analytical Methods Development

Scorpion offers a comprehensive range of cGMP biologics analytical testing services to support biomanufacturing. Existing methods can be tech transferred and/or custom methods can be developed in-house. Analytical test methods used for product characterization and QC release testing are qualified or validated to meet the specific needs of the client and cGMP regulatory requirements.

Scorpion employs a “phase-appropriate” approach to method development, qualification, and validation. As part of method development, key performance criteria such as accuracy, precision, linearity, specificity, system suitability, etc., are evaluated. These development data serve as a baseline for subsequent protocol-driven qualification and/or validation studies.

Scorpion performs method qualification of non-compendial product-specific methods to demonstrate their suitability for use in product characterization, QC release, and stability testing of drug substance and drug product intended for Phase I/II clinical studies. We recommend that full method validation be performed prior to utilizing methods during process validation, conformance lot manufacture, and characterization and QC release testing of drug substance and drug product for Phase III clinical studies. Tables A, B, C and D below show typical characterization and QC release tests for mammalian and microbial cell banks, cell therapy final cell product, protein therapeutics and plasmid DNA product.

A. Cell Bank Characterization: Mammalian & Cell Therapy

*Specific test methods for Identity, Purity, and Potency will be specified by the client.
**Cell Therapy Final Cell Product.

Test MCB WCB EoP FCP**
Cell count, viability + + + +
Sterility + + + +
Bacteriostasis, Fungistasis + + + +
Mycoplasma, Mycoplasmastasis + + + +
Endotoxin + + +
Adventitious virus testing +
In vitro virus testing +
In vivo virus testing +
Retrovirus testing +
Identity* + + + +
Purity* + + + +
Potency* + + + +
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B. Cell Bank Characterization: Microbial

*Specific test methods for Identity, Purity, and Potency will be specified by the client.

Test MCB WCB EoP
Cell count, viability + + +
Identity* + + +
Purity* + + +
Potency* + +
Detection of bacteriophage +
Plasmid retention + +
Plasmid identification +
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C. Protein Characterization & QC Release Testing

*Specific test methods for Identity, Purity, and Potency will be specified by the client.

  • Sterility
  • Bacteriostasis, Fungistasis
  • Endotoxin
  • Protein concentration
  • Purity*
  • Identity*
  • Potency*
  • Charge variants
  • Primary structure
  • Aggregation state
  • Glycosylation
  • Appearance
  • Particulate analysis
  • pH
  • Host cell DNA
  • Osmolality
  • Host cell protein
  • Residual antibiotic by E. coli growth inhibition test

D. Plasmid DNA Characterization & QC Release Testing

*Specific test methods for Identity and Purity will be specified by the client.

  • Bioburden or Sterility
  • Bacteriostasis, Fungistasis
  • Endotoxin
  • Optical density
  • DNA concentration
  • Appearance
  • DNA homogeneity
  • Plasmid identity
  • Restriction digest
  • Sequencing
  • Supercoil
  • Residual bacterial protein
  • Residual bacterial DNA
  • Residual antibiotic by E. coli growth inhibition test