Proteins, Enzymes, Biologics & More
Featured Product Line: Tumor Markers
Protein Extraction, Purification & Isolation
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.
GMP & Preclinical Production
Small to Large-Scale Production
Small & Large Molecule Manufacturing
We are able to provide expertise with both small and large molecule process development. A stringent quality system and operating standard is in place to allow for highly-effective and efficient product and assay development from pilot-scale for pre-clinical trials to large-scale commercial manufacturing. Our skilled team of scientists are in place to help with your project validation, process and analytical development. Our ISO-7 clean room is designed for the most stringent quality control of processes.
Native Proteins & Enzymes
Recombinant Proteins & Antibodies
Reagents, Chemicals & Solutions
Human & Animal Fluids, Tissues and Glands
GMP/OEM Production & Custom Purification of Biologics and Chemicals
Lee Biosolutions offers good manufacturing practice (GMP) and original equipment manufacturer (OEM) production and contract manufacturing services, 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 Testing & Technical Support
Our expertise with analytical characterization of proteins and knowledge of separation techniques along with a highly skilled quality control team, allows us to provide outstanding analytical and technical support to our clients. Our scientists can customize an experience that can help with product development and support.
Product & Assay Development
Our scientists can work closely with your research, production and marketing team to develop a product and assays that meets your most stringent requirements. We understand the importance of assay development ensuring key criteria such as quality, suitability, consistency, feasibility and cost. Our project team has the expertise to ensure that your product meets these requirements.
Process Validation & Optimization
Have a bench-top process that needs scale-up and optimization for commercialization? We'd love to learn about your requirements. Needing to transition from research grade product to full-scale GMP production? Not a problem for our highly-trained and experienced staff. We have the facility and knowledge to transfer processes. Does your organization need a fully validated process for key raw materials or finished product? We've accomplished this for some of the largest companies in the world, and can do so for you.
Specialty Biological Collections
Our clients worldwide come to us for specialty biological collections for both human and animal samples and specimens. We provide specimens from tissue, blood, saliva, urine, vaginal secretions, semen, tears etc. Because we are a manufacturer, we're able to custom collect under most protocols. We can profile specific donors for a disease, gender, age and ethnicity.