BioInsights - Realizing flexible automation – Closing gaps to meet industry needs

An emerging strategy to help incorporate automation into early PD is the use of systems that support integration of separate unit operations, while retaining the flexibility needed to bridge the translational gap.

In cell and gene therapy, many of the manual operations involve moving fluid from one place to another using traditional laboratory methods such as pipetting or syringes. While adequate for early development and small-scale manufacturing, these techniques carry inherent limitations (for example, process variability, lack of records and control, etc.) for translation to cGMP practices.

The motivation for such a solution should be to provide a platform with the capability to run multiple processing operations using a single base instrument. Sexton Biotechnologies is striving to address these needs with their expanding portfolio of enabling technologies. Here, they introduce the newly launched Signata CT-5™, which allows for cost-effective, early implementation of semiautomated processes with control and electronic records, while maintaining a high degree of flexibility that supports users in research, development, or commercial stage manufacturing. Related issues will then be discussed by a multi-stakeholder panel.

Attendees will learn:

Why the industry needs flexible automation
Impediments to integration of automated systems, and ways to overcome those problems
How novel automated solutions such as the Sexton Signata CT-5 can support multiple processes

Knut Niss, PhD

Chief Technology Officer, MustangBio

Dr. Niss has served as Chief Technology Officer since March 2018. Dr. Niss joined Mustang in March 2017 as Vice President of Operations, where he initiated and oversees the establishment of Mustang’s cell therapy manufacturing facility. Prior to Mustang, Dr. Niss was Cell Therapy Asset Leader at Biogen, where he oversaw CMC-related activities for gene-edited hematopoietic stem cell and lentiviral gene therapy programs for sickle cell disease and hemophilia, respectively. Earlier in his career, Dr. Niss was Senior Technical Project Leader at Novartis’ cell therapy manufacturing facility in Morris Plains, New Jersey, where he directed the transfer and implementation of the CTL019 process from Penn to Novartis. He also served as Senior R&D Program Manager at EMD Millipore, where he established processes for the large-scale expansion of adult and pluripotent stem cells. Dr. Niss began his career in senior research positions in Pfizer’s Regenerative Medicine and Immunology groups. He holds a Ph.D. in molecular biology from Humboldt University of Berlin, and an M.S. in microbiology from the University of Göttingen in Germany. Dr. Niss completed his postdoctoral research at Boston Children’s Hospital and the Dana-Farber Cancer Institute.

Steven Thompson, PhD

Vice President, Sales and Product Management, Sexton Biotechnologies

Dr Steven Thompson is currently Vice President of Sales and Product Management at Sexton Biotechnologies, with which he is also a co-founder. In his role, Dr Thompson engages with numerous ATMP manufacturing groups across the regenerative medicine and immune oncology sectors with a view to understanding the effect of processes on final product consistency and efficacy. Through this engagement, he and his colleagues at Sexton Biotechnologies have developed a platform of tools and reagents designed to increase process efficiencies and reduce failures, the latest of which is their Signata CT-5 fluid handling technology. Prior to his current role, Dr Thompson engaged with the ATMP manufacturing community as a Business Development Manager, and later as a Product Manager, at Cook Regentec. Following completion of his PhD in Stem Cell Biology from University of Liverpool, he worked at Sigma Aldrich (now part of Merck) with a focus on the gene editing technologies.

Professor Mark Lowdell

Director of Cellular Therapy & Biobanking at the Centre for Cell, Gene & Tissue Therapy, Royal Free London NHS FT & UCL

Mark trained as an immunopathologist at the Royal London Hospital and moved to the Royal Free Hospital / UCL in 1994 to set up the immunotherapy programme in malignant haematology. He has specialist knowledge of cellular therapeutics and is the UK representative on the Joint Accreditation Committee ISCT/EBMT (JACIE) which is responsible for setting and co-ordinating standards for cellular therapies across Europe. Mark holds Qualified Person status for the release of investigational somatic cell therapy medicinal products in the EU and is a Designated Individual under a Human Tissue Authority licence for therapeutic cells. Mark has been a Chief Scientific Officer and Chief Manufacturing Officer since the formation of the InMuneBio in September 2015. Since February 2009, he has also been Director of Cellular Therapy at the Royal Free London NHS Foundation Trust. He received his PhD in clinical immunology from London Hospital Medical College, University of London in 1992 and is a qualified immunopathologist.