Laysan Bio, Inc. (Laysan) is a Biotechnology company that offers novel polymers to customers for development of a wide variety of platforms. We supply cataloged, custom and compliant activated poly(ethylene glycol) reagents to Academics, Research Centers, Biotech and Pharmaceutical development companies. Laysan sells a large variety of activated polymers, accompanied with prompt customer service and technical assistance. Laysan has been in business since July 2006 and has shown steady growth since inception. The management team and key employees have been involved with the development and supply of PEG reagents for seven FDA or EU-approved drug products or medical devices, including Neulasta®, Somavert®, PEGASYS®, PEG-INTRON®, Definity®, Macugen® and DuraSealTM. Our current staff has substantial experience in process development, scale-up, compliant manufacturing, validation and program management to support our customer’s developmental and commercial programs. Our key employees have twenty plus years of experience in developing, manufacturing and managing the PEG reagents used in the listed programs.
Laysan has commissioned our 16,000 square foot manufacturing facility. This facility gives us the capabilities to manufacture active poly(ethylene glycol) reagents as compliant Bulk Pharmaceutical Chemicals (BPC) under all applicable regulations. Laysan is an FDA-registered company with a rigorous quality system. Compliant batch sizes are available from 100 g to kilogram scale for Laysan products. Laysan offers custom and catalog active PEG reagents from our small-scale production laboratory with batch sizes from a few grams to 1 kg. This facility also allowed us to expand our Quality Control department. We have added additional analytical equipment to better characterize our compliant final products as well as test all incoming raw materials used in compliant manufacturing. Our expansive 4.5-acre campus gives Laysan the opportunity to continue to grow and build additional facilities as needed to house larger manufacturing processes to supply large quantities of reagent for commercial reagents. A copy of our Quality Manual is available to customers considering Laysan as a compliant manufacturer and we are also pleased to host quality audits to approve Laysan as a vendor. Laysan is committed to supporting our customer’s requirements for active polymers for their programs from conception through development to commercialization of their drug product or medical device. Laysan is ready and willing to work in any way to ensure our product(s) fit your program requirements and we look forward to discussing this opportunity with you.
Thank You
Jon Mckannan
President