OEM Production & Custom Purification of Biologics and Chemicals

Lee Biosolutions is able to follow  GMP guidelines and offers original equipment manufacturer (OEM) production and contract manufacturing services under ISO 13485 requirements, utilizing our state-of-the-art  clean room and 41,000 sq. ft. research and manufacturing facility to accomplish every need of our clients. Our project team will work with you closely to define your specifications, help with process development, validation and scale up to meet market demand. We can take your product from concept to finished product. Project offerings include:


Method Development

Method Validation

In-Process & Final QC

Product Identity/Characterization


Feasibility Studies & Production

Process Development

Method Development

Laboratory Run Production

Engineering Run Production

GMP Production

Viral Clearance:

Viral Clearance Study Management


Stability Study Management

Analytical Testing Services


Chemistry, Manufacturing and Controls (CMC) Documentation and Advisement