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About Us

Who we are

Who we are

LePure Biotech was established in 2011. It pioneered localization of single-use solutions for biopharmaceutical industry in China. LePure Biotech has comprehensive capabilities in R&D, manufacturing, and commercial operation. LePure Biotech 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.

600+

Customers

30+

Patented Technology

5000+㎡

Class 10000 cleanroom

700+

Employees

What we do

LePure Biotech specializes 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

What we insist

LePure Biotech always insists quality first. It owns more than 30 core patented technologies related to bioprocess single-use systems. The products show multiple advantages in safety, reliability, low cost and environmental protection, and can help biopharmaceutical company better comply with the requirements of GMP, environmental protection and EHS regulations.

What we pursue

Driven by technology innovation, LePure Biotech has become trusted partner of global biopharmaceutical companies, promoted the healthy and rapid development of biopharmaceutical industry in the world, and made positive contributions to more precise and effective biopharmaceuticals for the general public.

What we pursue
Why choose us

Why choose us

- Customized total bioprocess solutions

- Ultra-clean process
     Class 5 and Class 7 Cleanrooms

- Compliance with international quality standards
     ISO9001 quality system/GMP requirements
     RNase/DNase free
     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

history

  • 2011

    - Company was founded

    - Localized the Single-Use process technology 

  • 2012

    - Obtained angel investment

    - Built a Class C clean plant

  • 2015

    - Certificated as a National High and New Technology Enterprise 

  • 2018

    - Expanded an extra SUS production line

    - Started self-developing homebred film

  • 2019

    - LePure Biotech’s “Special Nutrient Storage Solution and Products for Outer Space     Breeding” went with Chang’e 4 to the Moon

  • 2020

    - LePure Lingang Class 5 ultra-clean plant was put into operation
    - Supported COVID-19 vaccine project
    - “Specialized, Refined, Differentiated and Innovative” SMB Enterprise of Shanghai

  • 2021

    - Completed Series B and B+ financing
    - Innovative and specialized SMEs “Little Giant” rated by the Ministry of Industry          and Information Technology
    - Launched sterilizing-grade capsule filter
    - Successfully self-developed LeKrius® film
    - Successfully self-developed LePhinix® single-use bioreactor

  • 2021

    - Innovative and specialized SMEs ‘Little Giant’ rated by the Ministry of Industry            and Information Technology