Lee BioSolutions
P: 314-968-1091 E: order@leebio.com
Help: info@leebio.com

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 3,000 sq. ft. 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:

Analytical:

Method Development

Method Validation

In-Process & Final QC

Product Identity/Characterization

Process:

Feasibility Studies & Production

Process Development

Method Development

Laboratory Run Production

Engineering Run Production

GMP Production

Viral Clearance:

Viral Clearance Study Management

Stability:

Stability Study Management

Analytical Testing Services

Regulatory:

Chemistry, Manufacturing and Controls (CMC) Documentation and Advisement