Laysan 修饰性PEG代理–上海金畔生物科技有限公司

Laysan 修饰性PEG代理–上海金畔生物科技有限公司

Laysan Bio, Inc.是一家生物技术公司,为客户提供用于各种研发平台的新型聚合物。Laysan为学院,研究中心,生物技术和制药研发公司提供目录,定制和标准的活性聚(乙二醇)试剂。Laysan销售各种的活性聚合物,并提供快速响应的客户服务和技术支持。自2006年7月起执业以来,Laysan的业务呈稳步的增长。管理团队和骨干员工已经开发和提供PEG试剂用于7个FDA或欧盟批准的药品或医疗器械,包括Neulasta®, Somavert®, PEGASYS®, PEG-INTRON®, Definity®, Macugen® and DuraSeal™。Laysan的员工具有丰富的开发,放大,标准制造,验证和项目管理经验,以支持客户的研发和商业项目。Laysan的骨干技术在研发,制造,管理应用于上述项目的PEG试剂,具有超过十四年经验。Laysan还与其他技术公司一起合作,授权制造和销售与Laysan已经提供的聚(乙二醇)试剂品质一致的新型聚合物。

上海金畔生物代理优势:货期10个工作日左右。

Laysan Bio, Inc. (Laysan) is a Biotechnology company that offers novel polymers to customers for development of a wide variety of platforms. We supply catalog, 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 DuraSeal™. 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 fourteen plus years of experience in developing, manufacturing and managing the PEG reagents used in the listed programs. We are also working with other technology companies to allow Laysan to manufacture and distribute new novel polymers that compliment the existing poly(ethylene glycol) reagents we already offer.

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. Compliant batch sizes are available from 100g to a possible 20kg scale for most reagents offered. Laysan still offers custom and catalog active PEG reagents from our small scale production laboratory with batch sizes from a few grams to 1kg. 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.