At NORCAL GMP, rigorous Quality Control (QC) testing is integral to every stage of our biopharmaceutical development and manufacturing processes. Our dedicated QC laboratory, located within our state-of-the-art Hayward, CA GMP facility, is equipped with advanced analytical instrumentation and staffed by experienced scientists. We are committed to upholding the highest standards of quality, safety, and compliance, providing you with the robust data and assurance needed to confidently advance your therapeutic programs.

Our Comprehensive QC Testing Capabilities:

Our QC services are designed to support your product from unprocessed bulk through to final drug product, ensuring quality and compliance at each critical step. We perform a wide array of tests for Drug Product (DP), Bulk Drug Substance (BDS), and Unprocessed Bulk Product (UPB):

Quality Control Testing

    • Determination of pH and Appearance

    • Sterility USP and B&F (Partner)

    • Bacterial Endotoxin Detection Using the LAL Kinetic Chromogenic Method for Product Validation

    • Determination of Protein Concentration by UV/VIS Spectroscopy A280

    • CE-SDS (Reduced and Non-Reduced)

    • Size Exclusion HPLC (Purity)

    • cIEF

    • WCX-HPLC for charge heterogeneity

    • Osmolarity

    • Particulates

    • Potency assay (e.g., Binding ELISA)

    • Load volume

    • Bioassay or Binding ELISA (Potency Assay)

    • Determination of pH and Appearance

    • Microbial Limits or Bioburden

    • Determination of Protein Concentration by UV/VIS Spectroscopy (A280)

    • CE-SDS (Reduced and Non-Reduced)

    • Size Exclusion HPLC (Purity)

    • cIEF

    • Determination of Residual Host Cell Proteins by ELISA

    • Determination of Residual Protein A by ELISA

    • Bacterial Endotoxin Detection Using the LAL Kinetic Chromogenic Method for Product Validation

    • WCX-HPLC for charge heterogeneity

    • Determination of residual DNA by qPCR

    • Protein A–HPLC

    • Microbial Limits or Bioburden (Partner)

    • Bacterial Endotoxin

    • Mycoplasma Detection with Mycoplasmastasis (EP/USP) (Partner)

    • In Vitro Assay for Adventitious Virus Contaminants: MRC-5, VERO, and CHO Cells (Standard Duration) with Hemadsorption and Hemagglutination Endpoints (GLP) (Partner)

    • Detection of MVM DNA by qPCR using Taqman Technology (GLP) (Partner)

    • Transmission electron microscopy (TEM) with enumeration of retrovirus-like particle (Partner)