Corporate Announcements

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.

Lee Biosolutions is a healthcare biotech company that manufactures finished proteins for the research and clinical diagnostic and life science market.Today we are proud to announce the promotion of Matthew Lee as President and Chief Operating Officer.  Burton Lee will maintain his role as CEO and focus on strategic planning.

Burton Lee, Chief Executive Officer of Lee Biosolutions stated, " Matt’s leadership skills and business acuity has helped us maintain double digit growth and increased profitability allowing us to expand our operations. His dedication to our team, vendors and customers has made this management move as the most logical choice in order to maximize our potential for growth.”  

Matthew Lee holds a B.S. in Marketing Management from Missouri State University and joined Lee Biosolutions in 2012 as Logistics Manager. He was promoted to Vice-President of Business Operations in 2014 for his ability to improve operational efficiencies in the business. He is currently on the Board of Directors and not only continue running the day to day operations but will assist the CEO in applying creative solutions to strategic challenges.

About Lee Biosolutions, Inc.

We are a global healthcare biotech company that specializes in process development and bulk manufacturing of finished human and animal enzymes and related proteins for research and clinical diagnostic tests. Our products are used for such pathologies as cardiac disease, cancer, diabetes, urine analysis, coagulation, obesity, inflammatory, neurological, autoimmune diseases and immunological disorders. Our expertise includes process optimization and scale-up, bioanalytical development, validation and purification of biologicals. We are known for our ability to take a bench top pilot process and scale up to commercialization that is efficient and cost effective for our clients.

To Whom It May Concern,

We are pleased to announce that we will officially move to a larger facility on August 10^th.Please amend your records to our new contact details.

New Physical Address:

Lee Biosolutions, Inc.10850 Metro Ct, Maryland Heights, MO 63043

New Mailing Address:

Lee Biosolutions, IncPO Box 1569, Maryland Heights, MO 63043

Our new 41,000 sq. Ft facility will allow us to meet our growth projections by tripling our capacity, adding new employees and providing better service to our customers and vendors. We will not accept any deliveries to our old facility at 2924 Mary Ave after August 4^th.If you have any questions please email info@leebio.com

Burton Lee

 CEO

MARYLAND HEIGHTS, MO    / Lee Biosolutions is proud to announce that it has an exclusive Clinical Trail Supply Agreement with St. Teresa Medical, Inc. to support their SURGICLOT(R) Haemostatic Dressing. Lee Biosolutions' scientific team's extensive expertise with coagulation factors such as Human Thrombin and Fibrinogen made it an ideal partner to meet Saint Teresa Medical's requirements. St. Teresa Medical is a medical device company commercializing a new haemostatic technology platform.

Lee Biosolutions partnership with St. Teresa Medical ,covers the process development and manufacture of bulk cGMP Human Fibrinogen and Thrombin, analytical support and testing services, analytical methods development and validation, stability testing and viral clearance management. St. Teresa Medical owns the analytical methods and validation processes as a result of our close collaboration.

Burton Lee, CEO "St. Teresa Medical is an innovator in the market place and we are very proud that they chose Lee Biosolutions as a key supplier for this novel (or cutting edge) technology."

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

Lee Biosolutions’ facility is registered with the FDA. These products are produced in accordance with the FDA’s “Guidance for Industry: cGMP for Phase 1 Investigational Drugs” and Q7A, Section 19: “APIs for Use in Clinical Trials”.

Lee Biosolutions, Inc, a manufacturer and global provider of highly purified enzymes and related proteins for the life science, clinical diagnostic and the biotech healthcare industry, is proud to announce the addition of 3 new members to the Board of Directors reflecting its continued growth and expansion of the business.

President and CEO , J. Burton Lee says, “As a leader in the industry, we have a responsibility to maintain a strong articulated business strategy that will allow us to grow as our client base and product line continues to expand. I chose our members for their expertise, passion and commitment to make us a world class institution that will create a momentum in the market place that will be exciting for everyone doing business with us”

New Board Members

Matthew P. Lee is currently Vice-President with responsibilities that includes day to day operations of the business ensuring our company exceeds our customer expectations. Matthew holds a BS in Marketing Management from Missouri State University and joined Lee Biosolutions in 2012 as Logistics Manager. He was promoted to Vice-President in 2014 for his leadership and commitment to the business that has contributed to our highest growth in history of the company.

Daniel T. Fagan, PhD joined Lee Biosolutions in 2014 and brings a wealth of knowledge to the Board with his career spanning more than 37 years in both the Fine Chemical and Pharmaceutical Industries. His previous industrial experience includes the following: President of Sigma Chemical, General Manager of Mallinckrodt Peptides, President of PepTx, President, CEO and Chairman of the Board of Synthetech, Inc., Managing Director Brocair Partners as well as consulting over the last 15 years for various fine chemical, biotechnology and pharmaceutical companies.

Douglas D. Held, PhD joined Lee Biosolutions in 2010 and has focused on building the company’s core technical and scientific expertise and translating that expertise into new business opportunities. Doug has substantial experience in development and commercialization of processes for production and testing of biological molecules. Doug previous experiences includes a leadership positions at Singulex, Inc. and Sigma Aldrich, Inc. Doug has been issued four patents for biochemical methods for detection of human disease. Doug received a B.S in Chemistry and Biology from Iowa State University and a Ph.D. in Biochemistry from the University of Wisconsin, Madison, followed by post graduate training in Chemistry at the University of Iowa.

About Lee Bio

Lee Biosolutions is a producer of high purity finished enzymes and related proteins used by research institutions, IVD manufacturers and the biotech healthcare industries worldwide. LeeBio isknown 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.