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Quality Control

Our Quality Control (QC) team works closely with Manufacturing, Quality & Compliance, and Analytical Development / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure the success of the cGMP manufacturing operation. We are committed to continuously provide stringent support for the production of high-quality biopharmaceutical products through robust programs for sample management, analyst certification, data trending, and LIMS.

Analytical Testing Capabilities

The QC team performs testing on samples throughout the entire manufacturing process including raw materials, in-process, DS/DP release as well as stability.
The QC team is capable of analytical test method transfer from client expert laboratories and performing required method validation, qualification, or verification, according to ICH Q2 (R1) guidelines in order to satisfy the requirements of the U.S. FDA, EMA, and PMDA.

Our QC scientists provide expertise based on extensive experience in GMP laboratory environments, using validated cutting-edge equipment. The following are examples of some analytical test methods that our QC team is capable of:

  • Chemical Testing Chemical Testing photo
    • 1. pH, Osmolality, Protein Content (A280), Appearance
    • 2. Water content
    • 3. Identification by FT-IR
    • 4. Impurity / Purity by HPLC
  • Biochemical Testing Biochemical Testing photo
    • 1. Enzyme-Linked Immunosorbent Assay (ELISA)
    • 2. Polymerase Chain Reaction (PCR)
    • 3. Electrophoresis (gel-based / capillary electrophoresis)
    • 4. Cell-Based Assays
  • Microbiological Testing Microbiological Testing photo
    • 1. Microbial Limit (Bioburden)
    • 2. Endotoxin
    • 3. Microbial Identification
    • 4. Sterility

Stability Program Capabilities

A dedicated controlled area, with validated and monitored stability chambers, enables the collection of GMP Drug Product/Drug Substance stability data. Physical and kinetic stability profiles are generated using real-time storage conditions and accelerated conditions of temperature and/or light.

Environmental and Clean Utility Monitoring

QC ensures that controlled environments are maintained for the manufacturing of high-quality products, by routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.). All analyses are performed under strict cGMP requirements. Environmental Monitoring includes testing for Viable / Non-viable particulates, Settle Plates, and Contact Plates. Clean Utilities Monitoring includes testing for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.