Shanghai LePure Biotech was established in 2011. It pioneered localization of single-use solutions for biopharmaceutical industry in China. LePure has comprehensive capabilities in R&D, manufacturing, and commercial operation. LePure is a customer centric company with commitment to high quality and continuous improvement. Driven by technology innovation, the company wants to be the most reliable partner of global biopharma. It empowers Biopharm customers with high quality and innovative bioprocess solutions.
class 10000 cleanroom
LePure Biotech was established in Shanghai, China in 2011. We specialize in design, development and manufacturing of single-use equipment and consumables for bioprocess applications.
-We serve a wide range of customers in antibodies, vaccine, cell and gene therapy markets
-We Offer diverse products in R&D, pilot scale and commercialized production stage
-We provide comprehensive solutions in upstream cell culture, downstream purification and final filling in bioprocessing
- Customized total bioprocess solutions
- Ultra-clean process
Class 5 and Class 7 Cleanrooms
- Compliance with international quality standards
ISO9001 quality system/GMP requirements
USP <85>, <87>, <88>
ISO 10993 biocompatibility test, ADCF test
- Comprehensive validation services
Extractables and leachables
Sterile filter validation
Virus inactivation and clearance
- Innovation center and experienced sales team in the US
customer centric, quality first, striving for excellence.
Empower Biopharma with High Quality Bioprocess Solutions
Be the most reliable partner of global biopharma driven by technology innovation
Shanghai Lepure Biotechnology Company was established in 2011. It specialized in R&D and manufacturing single-use equipment and consumables for biopharmaceutical industry, and localized single-use process technology for China, and drove continuous advancement of bioprocess technology in China.
In 2012, Lepure Biotech obtained angel investment and rapidly developed into a leading single-use biotechnology enterprise in China.
2015 Lepure Biotech was rated as a high-tech enterprise。 It buit a technical team of high caliber, cross-functional and experienced professionals.
2017 Lepure Biotech launched single-use mixing system, creating a precedent of domestic single-use mixing system.
2018 Lepure Biotech expanded its cleanroom area, added a new SUS production line, and had 2100 sqm of Class 10000 cleanroom.
In January 2019, the 25ml 3D liquid storage bag made by Lepure biotech landed on the moon to provide moisture for the shoots in the biological science popularization load test of chang'e-4.
2020 Lepure built a new site in Ling-Gang Shanghai. It became the first single-use bioprocess equipment supplier in the world, having a C+A Class cleanroom and offering pre-washing service on components.
2021 new goal, new start, ten-year journey, set sail!
2019 Heroine Prize
2019 Lingang Technology Innovation Prize
2019 Xinqiao Technology Innovation Prize
2016 Caohejing Fastest Growth Prize
2016 Songjiang special SME
High tech enterprise certificate
single-use multilayer co extrusion bag
quality management system certification
Commerclization of high tech achievements
recognition of high tech Enterprises
Cell culture bag
single-use circulation transfer multilayer coextrusion bag for ultrafiltration
Sterile solution storage bag
Stainless steel transfer box
A tubing sealing machine