Release & Stability for Clinical Manufacturing

Evaluating the identity, strength, purity, potency, and safety properties of the drug substance and drug product upon release and over the course of its shelf life is critical for regulatory and marketing purposes.

KBI provides a complete range of ICH stability conditions and cGMP test methods to assure the accurate profile of your biopharmaceutical product.KBI excels in the performance of accelerated and long-term stability studies, from developing the protocol to delivering a technical document ready to be placed into your regulatory submission.

KBI’s release and stability program experience includes products in all stages of development, from preclinical to commercial, and covers the full spectrum of biopharmaceutical products, such as antibodies, enzymes, fusion proteins, PEGlyated proteins, conjugates, protein vaccines, peptides, and olionucleotides.KBI excels in the performance of accelerated and long-term stability studies, from developing the protocol to delivering.


Our services include:

  • Specification development for release and stability testing
  • Protocol development for stability testing
  • Design of studies and pull schedule
  • Cumulative reporting and trend analysis
  • ICH/cGMP stability programs for clinical and commercial products
  • Full analytical development, qualification/validation, and cGMP testing capabilities
  • 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
  • 21 CFR 210 & 211 compliant quality systems
  • FDA and EMA approved sample management, analytical laboratories, and quality systems
  • Submission-ready reports
commercial elease and stability KBI (click to enlarge)

KBI’s Clinical Release & Stability Capabilities

Identity

  • Peptide mapping

  • Western blot

  • ELISA

  • HPLC (SEC, RP, IEX, HIC, etc.)

Strength

  • UV (A280)

  • BCA, Bradford, etc.

  • ELISA

  • HPLC (RP)

Purity

  • HPLC (SEC, RP, IEX, HIC, etc.)

  • SDS-PAGE, IEF

  • CE (CE-SDS, cIEF, CZE)

Potency

  • Enzymatic activity

  • Cell based assay (proliferation, cytokine release, etc.)

  • Ligand-binding (ELISA, Biacore, Forte Bio)

Safety

  • Residual host cell protein via ELISA

  • Other process residuals (e.g., antibiotics, inducers, detergents, etc.)

  • Bioburden

  • Residual DNA via qPCR

  • Endotoxin

Quality

  • Appearance (USP/EP)

  • Osmolality

  • Residual moisture

  • Subvisible particles via HIAC and MFI, including evaluation of particles <10µm

  • Glycan profile via NP-HPLC, CZE, etc.

  • pH