- Market News
FUJIFILM Irvine Scientific introduces Sterile Express Media Service1 Dec 2020
The first-of-its-kind manufacturing service delivers tested sterile, non-GMP media designed for feasibility testing before scale-up, to support development of cell and gene therapies
FUJIFILM Irvine Scientific has launched Sterile Express Media Service (SEMS) for small-scale, rapid production of non-GMP (Good Manufacturing Practice) media tested for sterility.
According to the company, a rapid, non-GMP manufacturing service that delivers sterile cell culture media has not been available on the market.
Now, with SEMS, customers can request up to 100 L of media to be rapidly manufactured in a Grade A/ISO 5 sterile environment, and have it shipped within 15 business days pending sterility confirmation.
Contamination in culture media can affect cell characteristics such as growth, metabolism, and morphology, contributing to unreliable or erroneous results. This can cause delays in the development and scale-up process.
SEMS enables manufacturers to test the feasibility of formulations using sterile cell culture media before scale-up to more costly GMP manufacturing.
Sterile media provide an extra measure of control and security for valuable cells and streamline the successful development of cell and gene therapies and biopharmaceutical drugs.
Unlike the sterile-filtered and sterile-tested media currently available in the market, SEMS utilizes isolator technology to provide an aseptic manufacturing environment.
SEMS media remain in a Grade A/ISO 5 environment throughout the manufacturing process, reducing the risk of contamination for critical applications.
The non-GMP liquid media formulations are manufactured using the same qualified raw materials used for GMP manufacturing and are sterility tested according to USP71 and ISO 13408 requirements.
Erik Vaessen, Executive Director, Life Sciences at FUJIFILM Irvine Scientific said that by using sterile media trials, customers could reduce costs associated with developing therapies and biopharmaceutical drugs by reducing contamination risk during the testing phase.
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