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Stability and Release Tests

Althea Services

In-Process and Release Tests at Althea

Althea gives you access to a broad range of technologies for on-site release and in-process testing as well as stability studies for drug substances, developmental formulations and clinical trial products. On-site efficiencies provide you with time saving performance that is critical to IND, IMPD and early-phase clinical studies.

Both our Quality Assurance group and Analytics teams work together to execute the highest quality release tests and deliver you the data you need for clinical trial approval process. Our analytical scientists design, implement, and manage stability studies that are appropriate for your specific product and stage of clinical testing.

ICH compliant protocols are used to monitor the stability and release readiness of your product. The Althea analytical team is in direct communication with your clinical development team consistently sharing data, coordinating schedules, and planning upcoming tests.

  • Specification development for release and stability testing
  • Protocol development for stability testing
  • Cumulative reporting and trend analysis
  • ICH/cGMP stability programs for clinical and commercial products
  • ICH compliant protocols
  • Method transfer and optimization
  • Long-term and accelerated stability studies
  • Full analytical development, qualification/validation, and cGMP testing
  • COA generation and issuance
  • Full limited-access controlled facility and storage chambers
  • 24-hour computer-monitored facilities
  • Redundant back-up electrical power and HVAC
  • Photostability testing under ICH Q1B or custom conditions
  • Determination of retest dates and expiration dates
  • Submission-ready reports

Strength

  • UV (A280)
  • BCA, Bradford
  • ELISA
  • HPLC (RP)

Purity

  • HPLC (Size Exclusion, Ion Exchange, Reversed-Phase)
  • SDS-PAGE, IEF
  • CE (CE-SDS, cIEF, CZE)

Identity

  • Peptide mapping by LC-MS for release, stability, sequence confirmation
  • Western blot
  • Mass Spectrometry
  • ELISA
  • HPLC (SEC, RP, IEX, HIC, etc.)

Safety

  • Residual host cell protein via ELISA
  • Other process residuals (e.g., antibiotics, inducers, detergents, etc.)
  • Bioburden
  • Residual DNA via qPCR
  • Endotoxin

Quality / Other

  • Appearance (USP/EP)
  • Osmolality
  • Residual moisture
  • pH
  • Subvisible particles via HIAC and MFI, including evaluation of particles <10µm
  • Glycan profile via NP-HPLC, CZE, etc.

Potency

  • Enzymatic activity
  • Ligand-binding (ELISA)
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