Lee BioSolutions
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Proteins, Biologicals & More

Lee Biosolutions is a global biotechnology leader specializing in custom and bulk manufacturing and preparation of high quality finished enzymes and related proteins and biologicals that are used in clinical diagnostic tests for pathologies such as cardiac disease, cancer, diabetes, urine analysis, obesity, inflammation, neurological, autoimmune disease and immunological disorders. Our products are used by Research Institutions, IVD manufacturers and biotech healthcare companies worldwide.

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Featured Product Line: Cardiac Markers

We are the manufacturer of choice among the research community and commercial diagnostic industry for finished cardiac proteins and enzymes because of our scientific expertise. Order now.
Protein Extraction & Purification
Assay Development & Validation
GMP & Preclinical Production
Small to Large-Scale Production
Small & Large Molecule Manufacturing
Biological Collections

Protein Extraction, Purification & Isolation

We are unique in the industry because of our historical manufacturing experience with animal and human protein extraction, purification and isolation. Our expert team of scientists are able to tailor the purification development, process chromatography and protein characterization so that our clients can obtain the right product for their final application.We have developed some of the most successful formulations in the industry and will work with you from conception to finished product so you can have a successful product launch. Set up a meeting today and you will find our scientists highly skilled and able to provide you with the information you need to make that informed decision.

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

We are able to work with clients on the development of procedures and controls, manufacturing processes and can assist with required testing for Phase I and II biologics. Pre-clinical batches are manufactured to the highest standards in dedicated ISO-7, Class 10,000 clean rooms with processes and documentation customized to satisfy your specific requirements. We understand the level of manufacturing traceability that is required for pre-clinical phases of study. Our clients are assigned an experienced project manager who coordinates the entire process and works as a primary point of communication. Our team of experts can provide a detailed quotation for small pilot samples to commercialization of your product.Call us today so we can send a non-disclosure agreement and start your project right away.

Small to Large-Scale Production

Our state-of-the-art facility allows us for maximum flexibility and quick turnaround times for highly developed, complex manufacturing processes. From bench-top purification to large-scale bulk manufacturing, we are the leading experts in protein purification. This capability is important for customers who need a supplier that can meet a high standard of quality, stability, timing and quantity requirements. Our team works closely with clients to meet all requirement needed make them feel like part of our team.

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.

Biological Collections

We have become an industry leader for specialized biological collections and specimens. With an active human donor base in the hundreds, we are able to profile specific traits and diseases for your research of many of the rare and common biologicals. Our team also works closely with animal collection sites to procure the highest quality animal sera, blood products, tissues and glands for researchers and manufactures to ensure the collection meets your highest quality standards.Biological Fluid Collection TableBiological Tissue Collection Table
Native Proteins & Enzymes
Recombinant Proteins & Antibodies
Antibodies
Reagents, Chemicals & Solutions
Human & Animal Fluids, Tissues and Glands

Native Proteins & Enzymes

As a leading biotechnology company, we specialize in the manufacture of highly purified native animal and human proteins and enzymes for use in clinical diagnostic manufacturing, analytical research, antibody production, molecular biology, cell culture, and drug discovery among others. Our innovative preparative and analytical techniques allows us to meet both research and bulk manufacturing requirements.

Recombinant Proteins & Antibodies

Proprietary protein purification techniques allows us to provide high quality recombinant proteins and antibodies at a competitive price to clients worldwide from government and academic research institutions, biotechnology and pharmaceutical companies as well as reference laboratories.

Antibodies

Our affinity purified antibodies are generated and produced with high specificity and reactivity for use in labeling and immobilizations for ELISAs, Western blotting, RIA and immunohistochemistry applications worldwide.

Reagents, Chemicals & Solutions

Our high purity reagents are used as components in biopharmaceuticals, cell culture media, diagnostics, applied and life science research and specialty chemical markets worldwide.

Human & Animal Fluids, Tissues and Glands

Using advance techniques in collection, preservation and storage, our high quality biological samples and specimens play a vital role in research and manufacturing. Customized or validated collections are available.
GMP/OEM Production & Custom Purification of Biologics and Chemicals
Analytical Testing & Technical Support
Product & Assay Development
Process Validation & Optimization
Specialty Biological Collections

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 20,000 sq. ft. research and production 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.