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Lee Biosolutions is proud to announce the purchase of Creative Laboratory Products, Inc, complete product line. CLP was an Indianapolis, Indiana-based producer of human and animal cholesterol concentrates, such as Low Density Lipoprotein (LDL), High Density Lipoprotein(HDL) and delipidized serum products and sold the product line to Lee Biosolutions, Inc, on March 14th, 2016.

We are very happy to have their manufacturing team headed by Jason Proksch join Lee Biosolutions . Lee Bio will be assisting them with their move to St. Louis, MO. Transfer of technology and equipment to Lee Biosolutions manufacturing facility will be taking place during the next couple of months as the team wraps up current production. Lee Biosolutions will be utilizing CLP protocols and test methods, ensuring customers won’t be affected during the transition. Lee Bio team is preparing to perform Installation Qualifications (IQ) and Operational Qualifications (OQ) on equipment and instrumentation that is used in the production and testing of these products.

Burton Lee, CEO of Lee Bio says, “Dr. Gary Proksch , founder of Creative Laboratory Products was the first person to recognize the future of the lipoprotein market 30 years ago and his technology in providing stable, high quality lipoproteins has enabled diagnostic manufacturers worldwide to produce hundreds of millions of cholesterol tests over the years that have saved lives and created the market as we know today."

Matt Lee, President and COO says, " The addition of Bovine HDL , Bovine LDL Cholesterol Concentrate, Human LDL and HDL, delipidized serum and related products strengthens and expands our core product line providing both significant growth and capabilities allowing us expand in key diagnostics markets."

The transition of manufacturing CLP products to Lee Biosolutions will ensure that customers will be provided with high quality and consistent long-term supply with increased capacity for decades to come. CLP and Lee Biosolutions have had a close relationship for over 30 years and Lee Biosolutions’ expertise with process development and purification of proteins derived from both animal and human sources makes this a perfect fit that will provide for a seamless transition for customers.

Lee Biosolutions is a global biotechnology leader specializing in custom and bulk manufacturing and preparation of high quality finished enzymes, related proteins and biologicals used in clinical diagnostic tests for pathologies such as cardiac disease, cancer, diabetes, urine analysis, obesity, inflammation, neurological, autoimmune diseases, immunological disorders and more The company is known internationally for developing some of the most successful formulations for research, diagnostic and therapeutic markets. Lee Biosolutions is certified to ISO 13485:2003 and ISO 9001:2008 standards.

You can learn more about the company, its products, services and career opportunities by visiting its website at http://www.leebio.com

Lee Biosolutions, a leader in the manufacture of finished enzymes and related proteins for the diagnostic and life science industry announces that it has achieved ISO 13485:2003 certification for the manufacture of biologics under clean room conditions for the medical industry. ISO 13485 is an international standard that certifies a company's quality management system for regulatory purposes and addresses the development, implementation and maintenance of a quality system that is intended for use by medical device manufacturers.

Lee Biosolutions achieved ISO 13485 following significant investment in a new expanded facility and putting together an incredible team that was committed to exceeding the requirements needed to meet compliance.  Our Regulatory Affairs Manager, Kevin Doss and Quality Assurance Manager, Jon Klein were instrumental in our success and continue to guide our team in making our organization a world class organization.

Burton Lee, CEO says " We have a responsibility to our clients and the industry to continue to invest in our processes and personnel for critical raw materials that  meet industry and regulatory requirements that reduce  risk, improves safety, while increasing quality and capabilities with continued improvements.   

Matt Lee, President and COO says " Our customers are increasingly calling on us to assist them in meeting the growing demands of the industry regulators in both US and in Europe.  We are now able to custom manufacture ISO 13485 certified critical raw materials which will benefit our customers who are developing new and innovative products for the medical industry.  ISO 13485 shows our ability to maintain an effective quality management system which benefits not only the client but the industry."

Lee Biosolutions is a producer of high purity finished enzymes and related proteins used by research institutions, IVD diagnostic manufacturers and the biotech healthcare industries worldwide. LeeBio is known for its expertise, leadership and support by clients because of its ability to closely partner with them in the development, purification, scale up and commercialization of innovative products. LeeBio has both ISO 13485:2003 and ISO 9001:2008 Certifications.

Since it is not easy for customers to visit all the time we decided to develop a virtual tour. The tour will take you from the front door, through our incredible lobby with conference rooms, offices and through our outstanding state of the art laboratory. Where else will you find the incredible skylights and walls of curved glass to view a laboratory .   Just click on the link and click on “see inside”  

http://maps.google.com/maps/place?cid=15843113712320526791

We always want to hear feedback from our visitors. Please feel free to email me personally at burton at leebio.com

Best regards,

Burton Lee

CEO

MARYLAND HEIGHTS, MO  August 21, 2015 / Lee Biosolutions Inc. is a global biotech company producing highly purified enzymes and proteins that are used in research and commercial clinical diagnostic applications. The combination of increased capabilities with our new 41,000 square foot state-of-the-art Maryland Heights research and manufacturing facility and the scientific team's extensive expertise with protein purification has led to increased growth opportunities for the company in areas of endocrine, inflammation, coagulation, oncology, cardiovascular and autoimmune disease markets.

Burton Lee, CEO explained, "By strategically increasing our investment in research and manufacturing capabilities and expanding partnerships with our clients, we have carved out a successful business in the world-wide scientific community. We have developed some of the most successful purification processes in the industry and have been key suppliers to all major diagnostic companies and innovative clients such as St. Teresa Medical."

Lee Biosolutions stands out in the industry because of its historical manufacturing experience in mammalian tissues and serum protein extraction, purification and isolation. The company can tailor the purification, development, process chromatography and protein characterization to ensure our clients obtain the right product for their final application.

About Lee Biosolutions, Inc.:

We are headquartered in a 41,000 square feet state of the art cGMP-compliant facility in Maryland Heights, MO. Lee Biosolutions is a certified, licensed ISO, FDA, EPA and USDA leader in process development and bulk manufacturing of high quality purified enzymes and related proteins for research and clinical diagnostic tests. Lee Biosolutions products are used for such pathologies as cardiac disease, cancer, diabetes, urine analysis, coagulation, obesity, inflammatory, neurological, autoimmune diseases and immunological disorders.