Manufacturing as a Measure of Quality
VitaCyte’s manufacturing operation represents over a decade of improvement and optimization efforts to yield the most robust process using industry best practices and dedicated equipment and materials.
We begin with a precise, meticulous manufacturing approach that:
- Precisely controls our formulations
- Methodically keeps contamination levels low
- Takes extra care with packaging design and sizes for increased ease of use
Our results are consistent enzymes of superior quality and low contamination.
Our Enzyme Manufacturing Process
VitaCyte’s commitment to lot-to-lot consistency is engineered into our manufacturing process. Our rigorous process allows us to produce more defined, better characterized enzymes. The care we take in manufacturing means that, once you determine which of our formulations is optimal for your cell isolation or recovery process, you can expect subsequent lots of the same product to have a very similar enzyme composition to the initial lot you used to define the reagents for the procedure. That means you don’t have to rely on repeated lot testing to find an enzyme lot that works consistently for your application.
Building Manufacturing Excellence
VitaCyte’s products are characterized using physico-chemical and functional analysis of enzyme activities to ensure that their functional activity and purity meet our quality standards. Each step in our process is designed for precision, building on the previous step and optimizing our products for consistency and superior performance.
Manufacturing Facility Features
Our 6,000-square-foot manufacturing facility includes an ISO-7 rated fill/flush suite for low bioburden, as well as four ISO-8 rated purification suites dedicated for individual enzymes. We built flush panel clean room space for GMP Grade Manufacturing. Additional facility features include:
- Controlled & Environmentally Monitored Manufacturing Area
- Limited Access to Qualified Trained Personnel
- Unidirectional Process & Product Flow
- Qualified, Maintained, Calibrated & Verified Equipment
- Calibrated/Certification Against NIST Traceable Standards
We’re proud of our facility and how it helps us extend our capabilities as scientists, manufacturers, and consultants.