To Determine Optimal Dose of Cancer Therapies and Create Stocks of Consistent, High Quality Product for Clinical Trials
TAP Biosystems, (now part of the Sartorius Stedim Biotech Group), a leading supplier of innovative cell culture systems and consumables for life science applications; recently announced its Fill-It, automated cryovial filling system is being routinely used in clinical trials of novel cell-based cancer immunotherapies at children’s oncology units in three major US hospitals. The system is being utilised in research labs to help determine the correct dosage of cells to treat children with life-threatening cancers, as well as to create stocks of consistent, high-quality product in cryovials for clinical trials.
Scientists at the hospitals are using Fill-It to produce batches of around 400 cryovials per run, with each 1ml vial containing between 40 and 100 million cell/ml of cell immunotherapy, depending on their requirements. These therapies consist of cancer cell lines donated from children suffering with life-threatening cancers. From each batch of vials produced, clinicians select a number of vials to use as treatment for the children. The remaining vials are frozen down and used at a later date.
The Fill-It automated system is ideally-suited to the demands of working with cell-based therapies as a rack of 24 product vials can be created every two minutes, maintaining optimum product quality and ensuring vial-to-vial consistency. Each product is aseptically processed using GMP-certified, single-use tubing that has been specially-designed to ensure minimal cell damage during dispensing.
Stephen Guy, Fill-It Product Manager at TAP commented: “This important clinical research application of our technology in major US hospitals demonstrates to scientists and clinicians in cell therapy units that a Fill-It system is an excellent technique of producing batches of vials for determining optimum cell therapy dosage, and for generating stocks of consistent, quality product for clinical trials.”
About TAP Biosystems
TAP Biosystems (now part of the Sartorius Stedim Biotech Group) is a leading global provider of automated cell culture and fermentation systems for life science research, development and production.
TAP's systems are in use worldwide at pharmaceutical, biotechnology and academic laboratories, supporting bioprocess development and GMP manufacture of biologics and cell therapies, discovery and stem cell research programmes.
The company has offices in the UK and USA, as well as an extensive network of distributors in Europe and Asia offering pre- and post-sales support. For more information, visit www.tapbiosystems.com.
SOURCE: TAP Biosystems