• Quality Systems and detailed GMP documentation.
• Modular manufacturing protocols where kits are assembled
..for each order
• Typical batch size for most components is 100 to many thousands.
• Parallel testing is routinely performed and recorded
• Accelerated and real-time stability testing with retainer storage
..are standard procedure
• All assembled kits are inspected prior to shrink-wrapping
• Batch specific quality control and documentation
• All biological materials are stored at -80C, -20C or at 4C
..in our facility
• Established relationships with bulk suppliers for TMB substrate
..and other lab chemicals as well as all plastic materials