Cell Therapy | Corning

Unleash the power of cell therapy

When it comes to creating breakthrough cell therapies with the power to cure the incurable, nobody has all the answers. That’s why Corning is committed to helping you orchestrate groundbreaking discoveries in the lab – and quickly turn up the volume to production.

As a leader in cell culture, Corning provides platforms that scale predictably and with ease. Our advanced cell culture surfaces, vessels, media, and closed systems work in harmony to ensure cell viability, reproducibility, and regulatory compliance. Working in concert, our applications team can help guide you through process design, product customization, and protocol development.

Together we can fuel the future of cell therapy and unleash its full potential – without missing a beat.

Sign up for regular updates.

Solutions for Cell Therapy

Corning offers an extensive selection of stacked vessels, closed systems, advanced surfaces and microcarriers for scaling-up both anchorage-dependent and suspension cells. We have been at the forefront of upstream single-use technology, with cell culture products that provide reliable, predictable scale-up in research, bioprocess and cell therapy. From process development to cGMP manufacturing, we’ll work with you to develop a customized platform to accomplish your specific goals. 

A partner as comfortable in the research lab as the production suite

As a leader in cell culture, Corning has been working with scientists to help solve specific research, scale-up and production challenges. We’ve taken these opportunities to develop custom solutions that enable successful research and development through to scale-up and production.

 

Whether it’s developing new solutions or determining a novel way to configure existing products, our experienced applications team will guide you to the exact end-to-end solution you need to deliver viable cells and high yields.

Application services include:

•  Cell scale-up and scale-out platform designs
•  Surface selection
•  Media selection
•  Process and protocol development
•  Closed-processing system development

Working side-by-side with our customers to help transform research into real life changing discoveries has become our trademark. We’re ready to help you develop and optimize your research and scale-up processes.

Contact Us

Exceptional Quality and Traceability

 

Most Corning cell therapy products are US Class I medical devices that are manufactured under cGMP in an ISO 13485 or ISO 9001 certified and FDA registered facilities.

 

Quality Management System Corning Cell Therapy products comply with the current version of the EN ISO 9001 Standard and/or the EN ISO 13485 Standard, as well as the FDA CFR 21 Part 820, current Good Manufacturing Practices (cGMP).
BSE/TSE Corning solutions for cell therapy comply with the latest revision of EMA/410/01 "Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products" by virtue of all bovine derived material having been processed per specific conditions of section 6.4 of EMA/410/01.
USP Class VI Testing All material resin is tested, qualified and shown to be non-toxic as established in the Standard USP Class VI. Materials have also met USP 1043 ‘ancillary materials for cell, gene, and tissue-engineered products’. 
Nonpyrogenic Corning Cell Therapy Solutions have been tested and met the criteria established in the current version of ANSI/AAMI ST 72: "Bacterial Endotoxins Test".
Sterility Products have been sterilized and dosimetrically released per the requirements of ANSI/AAMI/ISO 11137, "Sterilization of health care products - Radiation".
Quality Control Testing  Representative production samples are collected and inspected in accordance with current applicable product specifications. Inspection records are reviewed and approved by qualified personnel for product release.

 

Please note that all quality statements may not apply to all Corning Cell Therapy products. Please contact us for detailed information on individual products.

Certificates of compliance or validations guides for Corning cell therapy products are available upon request. Please contact us with your request.

Cell Therapy Featured Resources