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.