– The license agreement includes access to a cell processing prototype developed by a consortium led by Lonza and University College London’s Department of Biochemical Engineering.
– The new system allows for removal of cryopreservatives at the point of patient care
– Closed Cell Systems, Ltd. is a new company focused on commercializing equipment and providing services for the processing of cellular therapeutics
– The license agreement will allow Closed Cell Systems to further develop and commercialize the prototype point-of-care system for sale into the Cell Therapy market
Closed Cell Systems, Ltd (CCS), a recently established company, announced today that they have licensed a new cell processing technology from Lonza and UCL Business PLC (UCLB), the technology transfer office of University College London (UCL). This academic and industry collaboration will allow for the development and commercialization of a new cell therapy processing system for use at the point of patient care.
Cryopreservation of cellular therapeutics involves the addition of preservatives such as dimethyl sulfoxide (DMSO) to the cells prior to freezing. Before administering the therapy to the patient, the cellular therapeutic must be thawed, the preservative removed, and the final product put into dosage form. As current manual techniques have sufficed for early clinical trials, the need for an automated point-of-care process that will maintain the quality and safety of the therapy will grow as the market for cellular therapeutics increases.
Lonza, UCL, eXmoor pharma, and Amercare have been collaborating on a joint project to develop a modern point-of-care processing system for cellular therapies, with co-funding provided by the UK’s innovation agency, Innovate UK. The outcome of the collaboration was a novel, fully automated, and closed filtration system for the point-of-care preparation of cell therapy products. The system removes the additives while preserving the small volumes and cell viability needed to maintain efficacy. The prototype system can take the cellular therapeutic from frozen phase through to the dosage form.
The start-up company CCS was formed to further develop and commercialize the prototype. CCS has additional funding from Innovate UK for the project and an exclusive license for the technologies from Lonza, UCLB and the other collaborators. CCS will finalize the engineering and validate the commercial system in a clinical environment. CCS will assist future clients with the implementation of this point-of-care system into their manufacturing processes.
“Cellular therapies will require reliable, user-friendly processes at the point-of-care. This collaboration has resulted in an innovative, closed and automated system for dose preparation that will help meet this need,” said Uwe Gottschalk, Chief Technology Officer of Lonza Pharma&Biotech. “The development of the new system and start-up of a new company is an important outcome of the collaboration between the groups. As a leader in this field, Lonza is committed to personalized medicine and we will continue to enhance our portfolio directly and through collaborations.”
“This new point-of-care processing system is typical of the type of solutions that we wish to help clients develop as they meet the challenges of increased cell therapy production volumes,” said Dr. Martin Smith, Manager CCS. “Our intention is to work with cell therapy manufacturers to map their end-to-end manufacturing processes and deliver engineered improvements that match their business strategy.”
About Closed Cell Systems Ltd (CCS)
CCS has been established to assist the emerging field of cell therapy manufacturing as it transitions from essentially R&D based processes towards full scale, volume manufacture. The key challenges are to reduce risk and cost by closing, automating, integrating, and tracking unit operations, whilst maintaining small, and often individual patient, batch sizes. CCS is owned primarily by the directors of Amercare and eXmoor pharma, who will remain active in growing the business.
Further information can be found at www.closedcellsystems.com
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 full-time employees worldwide. The company generated sales of about CHF 3.64 billion in 2014 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients.
Further information can be found at www.lonza.com
About UCL Business PLC
UCL Business PLC (UCLB) is a leading technology transfer company that supports and commercialises research and innovations arising from UCL, one of the UK’s top research-led universities. UCLB has a successful track record and a strong reputation for identifying and protecting promising new technologies and innovations from UCL academics. UCLB has a strong track record in commercialising medical technologies and provides technology transfer services to UCL’s associated hospitals; University College London Hospitals, Moorfields Eye Hospital, Great Ormond Street Hospital for Children and the Royal Free London Hospital. It invests directly in development projects to maximise the potential of the research and manages the commercialisation process of technologies from laboratory to market.
For further information, please visit: www.uclb.com
About UCL Biochemical Engineering
The UCL Department of Biochemical Engineering is a world leader in bioprocess research creating novel engineering solutions to underpin future biomanufacturing operations across a range of sectors. The interdisciplinary Advanced Centre for Biochemical Engineering (ACBE) coordinates bioprocess research and training across UCL and with numerous external collaborators from academia and industry. In the recent Research Excellence Framework assessment (REF2014), 90% of our research activity was rated either ‘World Leading’ or ‘Internationally Excellent’. Our research addresses challenges in the three most important sectors of the advanced bioprocess-using industries: The Industrial Biotechnology, Macromolecular Medicines and Cell Therapy Bioprocessing.
The focus of Cell Therapy Bioprocessing activity is to accelerate the safe, clinical efficacious and cost effective translation of cell therapies into commercial products. This activity spans the entire range of cell therapy activities as well as tissue engineering. The distinctive UCL approach involves taking a ‘whole bioprocess’ view from donor or patient biopsy all the way through to clinical implantation into the patient. To date fundamental bioprocess research in collaboration with clinical groups and companies has supported the development and clinical application of various cell therapies. Achievements include preclinical filing for Phase 1 clinical trials for cell therapy in acute spinal cord injury, clinical proof of concept studies in tissue-engineered trachea, clinical trials for tissue-engineered larynx and routine clinical practice in the regeneration of corneas. Future research priorities will focus on novel cell and bioprocess engineering techniques to improve manufacturing efficiency and methods for health technology assessment to support rapid clinical adoption of new cell therapies.
Through multidisciplinary collaborations with clinicians and industry, our mission is to provide the research expertise to enable the manufacture of safe, clinically efficacious and cost effective cell therapies for delivery to patients.
Closed Cell Systems, Ltd
Dr. Martin Smith
Phone: +44 (0) 7495 089321