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.
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
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
