Automation of cell & gene therapy manufacture: challenges, options & opportunities for innovation

Associate professor at UCL’s Advanced Centre for Biochemical Engineering, Qasim’s research focus is on addressing translational challenges of robust manufacture of stem cells that are needed to take regenerative medicines into the clinic. This includes the “whole bioprocess” from sourcing of raw materials and cells, through cell expansion in bioreactors and ultimately the downstream processing needed to purify and concentrate cell product for delivery to the patient. He previously lectured in Bioprocess Engineering at Aston University, where he was Principal Investigator on 4 grants with funding from RCUK, EU Horizon 2020, InnovateUK and commercial sources. Qasim completed his PhD at Loughborough.

Brian Hanrahan has more than 15 years of product development experience across the biomedical and cell therapy industries. In his current role, Brian is the Manager of Invetech’s Cell Therapy Group in San Diego, CA, USA, helping cell and advanced therapy companies across the globe realize clinical and commercial-scale cGMP manufacturing solutions. Brian has been a key contributor in building Invetech’s cell and advanced therapy capabilities and continues to have a deep involvement in projects ranging from the development of cell separation instruments to single-use, automated cell therapy production systems. Brian has a bachelor’s degree in Applied Science from RMIT University in Australia.

Biren Mistry is currently a Senior Bioengineer in Bioprocess Development at Celgene Cellular Therapeutics in Warren, NJ. Prior to joining Celgene, Biren’s developed therapeutics that include recombinant proteins, plant-derived secondary metabolites, bacterial natural products, and biosimilars. He worked on upstream development, scale-up, primary recovery, process chromatography, PEGylation, and Technology Transfer to contract manufacturing organizations. At Celgene, Biren and his team are responsible for identifying and developing technologies for immunomagnetic cell isolation, cell expansion and differentiation, and cell washing. He has led the development of a secondary generation manufacturing process utilizing microcarriers and stirred-tank bioreactors for cell expansion and fluidized bed centrifugation for cell washing. Recently his team has focused on developing a manufacturing process for producing natural killer cells from cord blood-derived hematopoietic stem cells. Biren received his B.S. and M.S. degrees in Chemical and Biochemical Engineering from Rutgers University.

Dr Mary Murphy is a Senior Lecturer in Regenerative Medicine and the Principle Investigator in Orthobiology at the Regenerative Medicine Institute. Her primary research interest and motivation is the development of innovative medicines to treat major diseases using adult stem cells. Current clinical research focuses on the therapeutic potential of mesenchymal stem/stromal cells (MSCs) in osteoarthritis and she is currently a member of the ADIPOA2 consortium to implement a Phase II clinical trial for osteoarthritis patients (http://adipoa2.eu/). Applied research has a focus on developing economically-feasible automated manufacture of MSCs for therapeutic use and she leads the EU-funded AUTOSTEM consortium to achieve closed, automated and sterile pipeline for large-scale production of therapeutic stromal cells (http://www.autostem2020.eu/). Basic research is focused on the (1) mechanism of action of stromal cell in modulation of osteoarthritis, (2) the concept that stem cell depletion or dysfunction contributes to the development of osteoarthritis or atherosclerosis, (3) the use of the chondrogenic differentiation of MSCs as a model to study osteoarthritis development and (4) the role of inflammation in disease progression. This research ultimately aims to identify novel targets for drug development. Tissue engineering efforts address generation of novel materials for cartilage repair and development of targeting strategies and drug delivery modalities for non-invasive delivery of therapeutic cells and drugs to osteoarthritic cartilage using micro- and nano-particles.

Kate Sneddon is the Chief Executive Officer of Biovault Technical Ltd, a leading tissue and cord blood bank in the UK. Biovault provides high quality, ethical and cost effective tissue banking for clients in both the private and public sectors in the UK, across Europe and further afield. Kate joined Biovault in 2009 and prior to her current role held Operational, Quality and Technical roles. Kate has a 1st Class Honours degree in Microbiology from Newcastle University. From 1999 to 2009 Kate worked for GlaxoSmithKline where she held a number of positions including Microbiology Manager, Lean Sigma Expert, New product Project Manager and Value Stream Leader. Kate’s desire to move to the South West of the UK drew her to Biovault and a new sector in the healthcare industry. Her experience in Pharmaceutical development and manufacture has allowed her to apply a lot of this knowledge to Biovault. Kate lives in Cornwall with her husband and 2 daughters, and makes the most of living in the Wild West!