Lee BioSolutions
P: 314-968-1091 E: order@leebio.com
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Assay Development & Validation

Our Analytical Team has decades of experience in assay development and full validation of test methods and processes. We specialize in working with small organizations and start-ups, getting their groundbreaking ideas and technologies to commercialization, offering more attention and detail to a project than the large contract manufacturers are able to provide.

Below, you'll find a brief listing of services offered.


Analytical:

Method Setup

Method Validation

Batch QC

Product Characterization


Process:

Method Development

Process Setup

GLP/Engineering Batch Production

GMP Production


Viral Clearance:

CRO Studies

- Full Project Support and Management


Stability Studies:

CRO Studies 

- Full Project Support and Management

- Real-time, Accelerated and Stress Testing


Regulatory Documentation:

CMC Documentation