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Quality Control and Assurance

Integrated quality control and assurance carried out by regulatory experts

Your Program is in Good Hands

Comprehensive quality control is a cornerstone of our commitment to ensuring the highest standards of safety and efficacy for every biopharmaceutical product we deliver. With a focus on precision and compliance, an exemplary regulatory track record, and a QC team experienced in regulatory filings, we are dedicated to upholding the integrity of our offerings and exceeding regulatory expectations.

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Comprehensive Testing Framework

Tanvex’s quality control capabilities exemplify our unwavering dedication to delivering biopharmaceuticals of the highest quality. Our advanced processes, cutting-edge technology, and experienced team ensure that your products meet and exceed global regulatory standards. 

Our quality control framework includes:


  • Incoming Raw Material Testing: Thorough assessment of raw materials ensures their suitability and conformity to our stringent quality standards
  • In-Process Control Testing: Real-time monitoring during production safeguards product consistency and compliance
  • Product Release Testing: Final products undergo meticulous testing to guarantee their readiness for distribution
  • Generation & Qualification of Assay Cell Banks: The establishment and validation of assay cell banks support accurate and reliable analytical testing
  • Qualification of GMP Reference Standard: Rigorous qualification of reference standards enhances the accuracy of testing methodologies
  • ICH Compliant Stability Studies: We design, execute, and analyze stability studies in accordance with ICH guidelines, ensuring product shelf-life determination
  • Phase-Appropriate Method Qualification/Validation: Analytical methods are tailored and validated for each phase of development to ensure reliability
A person using equipment in a laboratory setting for cell line development

Quality Control Equipment

Our team has firsthand experience in interfacing with regulatory bodies, including the USFDA. Leveraging state-of-the-art equipment and cutting edge techniques, we can ensure your program remains compliant at every phase of its lifecycle. Our San Diego facility is equipped with:


  • HPLC & UPLC Systems: High-Performance Liquid Chromatography and Ultra-Performance Liquid Chromatography systems enable precise and accurate substance analysis
  • CE-SDS (Laser Induced Fluorescence): Capillary Electrophoresis with Laser-Induced Fluorescence detection to ensure accurate characterization of proteins
  • Plate Readers: Advanced plate readers facilitate Enzyme-Linked Immunosorbent Assay (ELISA) and endotoxin testing
  • Vi-CELL Automatic Cell Counter: Precision cell counting for cell-based assays
  • qPCR: Precise nucleic acid analysis
  • UV/Vis Spectrophotometer: Accurate UV/Visible light analysis supports substance quantification
  • HIAC Particle Counter: Precise measurement of particle size distribution in liquid samples
  • Sievers Total Organic Carbon Analyzer: Accurate determination of total organic carbon supports purity assessment
  • ICH Compliant Stability Storage: Controlled conditions for stability studies are maintained according to ICH guidelines
  • Cryo Freezers: Assay Cell Banks are stored in cryo freezers to maintain cell viability and integrity

Get Started with Tanvex

Let’s discuss your next biologics program