Manufacturing ExcellenceManufacturing 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 ProcessPurified & Characterized
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. Our 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.
Fermentation
Bovine source free (porcine) gelatin. Optimized for hight level enzyme expression.
Chromatography
Dedicated columns & resins. High resolution for high purity.
Ultrafiltration
Dedicated ultrafilter membranes. Aseptic filtration to reduce bioburden.
QC Testing
Biochemical assays to characterize bulk purified components for performance consistency.
Blend, Fill, Dry
Aseptic blending on enzyme activity. Freeze dried & sealed under vacuum for stability.
Final QC Testing
Comprehensive characterization using a variety of enzyme assays & endotoxin testing to ensure the batch meets established specifications.
Facility Features
‘Our 7,600-square-foot manufacturing facility is built using flush panel clean room construction for GMP Grade Manufacturing. These clean room spaces include an ISO-7 rated fill/finish suite containing ISO-5 BSC used for material handling to minimize bioburden.
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
Facility Views
We’re proud of our facility and how it helps us extend our capabilities as scientists, manufacturers, and consultants.
