Journal Archive

Editorial

Emerging Automated Approaches for Cell and Gene Therapy Manufacture

Spotlight Article

EDITORIAL

Qasim A Rafiq

Critical Role of Automation in the Manufacture of Cell & Gene Therapies

A sign of the growth of the advanced cell and gene therapy (CGT) industry is the reframing of the key discussions and critical challenges. Over the past decade the key conversations have shifted from being focused on how to attain regulatory approval to the more recent focus on how to realise true commercial success. To achieve this has required a shift in the way we conceptualize the state of the field whereby we now acknowledge this is no longer simply a clinical or scientific endeavour, but requires an industrial or manufacturing mind-set in order to improve product efficiencies whilst maintaining quality and minimizing costs.

Published: 20 Nov 2018
DOI: 10.18609/cgti.2018.070
Citation: Cell Gene Therapy Insights; 2018; 4(9), 911-914
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Interview

Automation: the Key Enabler of Point-of-Care Cell & Gene Therapy Manufacturing

Spotlight Article

Interview

Lutz Uharek

Critical Role of Automation in the Manufacture of Cell & Gene Therapies

Lutz Uharek is professor and senior physician at the Charité. As a haematooncologist he has a long experience in caring for patients with difficult-to-treat hematological disorders, in particular leukemias and lymphomas. Since his doctoral thesis, he has the vision to cure diseases with cells filled in bottles. Working in the field of stem cell transplantation and clinical cell therapy for many years, he gathered experience both in experimental research and clinical trials. Responsibility as Principal Investigator for Phase I and II trials and as Qualified Person for cellular products made him familiar with Quality Assurance Systems for GMP-compliant manufacturing and GCP-compliant clinical research. Under his responsibility, Charité became one of the largest manufacturing organisations in Europe for autologous and allogeneic stem cells and cellular products. Confronted with the administration of high-throughput pharmaceutical manufacturing of cell products during the last years, he has actively expanded his expertise in process, change and lean management. The current focus of his work is the production, clinical testing and application of genetically modified immune and stem cells. As part of partnerships with industrial companies, he is involved in the development of innovative biotechnology systems for personalized medicine.

DOI:10.18609/cgti.2018.088

Citation: Cell Gene Therapy Insights 2018; 4(9),873-877.
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Moving from Retrofitting to Made for Purpose Manufacturing Equipment

Spotlight Article

Interview

Nina Bauer and Richard Grant

Critical Role of Automation in the Manufacture of Cell & Gene Therapies

Nina Bauer Lonza Cell Therapy
Nina Bauer, a key figure in the cell and gene therapy community joined FloDesign Sonics in September as VP of Business Development. She leads the commercial aspects of establishing, launching, and further adoption of this disruptive technology. Previously Nina led Lonza’s Autologous Cell Therapy business, with manufacturing sites in the US and Europe. As part of this role, she was also in charge of establishing novel manufacturing technologies, most notably the Octane Cocoon™ platform. Prior to joining Lonza, Nina held business development roles at the Cell Therapy Catapult (London), and the University of Edinburgh, and worked as Life Science Consultant for regenerative medicine businesses.

Richard GrantRichard Grant, Chief Product Officer of FloDesign Sonics, has 33 years of product development experience across various industries including cellular therapy automation, medical devices and instruments, commercial valving and fluidic systems. Richard recently joined FloDesign after 17 years at Invetech where he played an instrumental role in managing the development of many products, from drug discovery and cell separation, to automated cell therapy production systems. For 15 years Richard has been involved in developing cell and gene therapy automation equipment and disposables where he led Invetech’s first cell therapy projects and following a four-year period where he established an office in San Diego as VP & Operations Manager, he was subsequently appointed as Global VP of Cell Therapy. Over his career Richard has been involved in over twenty cell therapy projects across the globe. Richard’s recent move to FloDesign Sonics comes with a brief to embody FDS’s breakthrough acoustic technology into a broad range of closed and scalable products for cell and gene therapy manufacturing.

DOI:10.18609/cgti.2018.089

Citation: Cell Gene Therapy Insights 2018; 4(9), 941-946
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Yescarta and the Automation of Manufacturing

Spotlight Article

Interview

Tim Moore

Critical Role of Automation in the Manufacture of Cell & Gene Therapies

Tim Moore Gilead

TIM MOORE has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Most recently, he served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of ISPE, PDA and has been a part of the Executive Committee of BioPhorum and the Manufacturing Leadership Council. Mr Moore received a BS in Chemical Engineering from Tulsa University and a MS in Engineering Management from Northwestern University.

DOI: 10.18609/cgti.2018.064
Citation: Cell Gene Therapy Insights 2018; 4(9), 665-670
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Conference Insight


Expert Insight

Automation: what will the cell therapy laboratory of the future look like?

Spotlight Article

INNOVATOR INSIGHT

Wenyan Leong, Brian Nankervis & Jim Beltzer

Critical Role of Automation in the Manufacture of Cell & Gene Therapies

With the recent successes of CAR-T cell therapies there has been a renewed interest in bioprocessing and the manufacturing facilities required to meet the demands. Increasing the scale of any process has potential risks as well as rewards. While the drive to automation is clear, there is a lot of debate on the strategy. The decision on whether and when to automate a particular step can have long-term consequences on the therapies’ cost-of-goods (COGs) and their successes. Automating the most complex and error-prone steps of a process is thought to be the best alternative to manual processes. However, automation may not be possible or even recommended for all steps in a process. Here, we examine both the barriers and the advantages of automation. Additionally, a detailed discussion of automating the autologous CAR-T cell process will look at each step from collection to infusion, and discuss the current automation offerings and speculate on potential future process changes. Through application of process analytics, we can gain a deeper understanding of the processes’ consistency and tailor automation to fit the process. New potency assays will improve manufacturing processes and ensure the delivery of a safe and effective product. These advancements will then shape the cell therapy laboratory of our future.

Submitted for review: Aug 10 2018 Published: Nov 20 2018
DOI: 10.18609/cgti.2018.067

Citation: Cell Gene Therapy Insights 2018; 4(9), 679-694.
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Strategies for Dealing with Donor Variability

Spotlight Article

EXPERT INSIGHT

Daniel Gibson, Christopher Leonforte & Alejandro Madrigal

CRITICAL ROLE OF AUTOMATION IN THE MANUFACTURE OF CELL & GENE THERAPIES

The growth of cell and gene therapies has opened the doors to revolutionary new treatment options by harnessing the power of the body’s own cells (or donors cells in an allogenic setting). Cells that are highly specialised in a complex network, further modified to overcome the complexity of disease evasion. complex solutions come with complex challenges one of which is the donor variability associated to the cell source. Stem cell transplant have been a curative treatment for patients with blood cancer and other haematological disorders for over 60 years. Here we explore the challenges and strategies employed in this setting to overcome the hurdles of donor variability.

Submitted for peer review: Aug 24 2018
Published:
Nov 20 2018
DOI:
10.18609/cgti.2018.087
Citation: Cell Gene Therapy Insights 2018; 4(9), 901-909.
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Automated Cell Expansion: Trends & Outlook of Critical Technologies

Spotlight Article

Ying Ying Wu, Derrick Yong & May Win Naing

CRITICAL ROLE OF AUTOMATION IN THE MANUFACTURE OF CELL & GENE THERAPIES

Cell therapy products (CTP) are set to experience a surge in demand by the mass market in the coming decade. Automation is expected to play a key role in meeting this demand. In this review, we summarize the features of current automated cell expansion systems and highlight some of the trends and promising developments. The focuses of current systems are enabling scalability, maintaining sterility, eliminating contamination and controlling quality. To attain full automation of CTP manufacturing, several challenges have to be overcome. We identify challenges pertaining to scalability via sterile reconnections, direct cell measurements for cell-specific quality control, logistical issues in traceability, temperature control during transport, as well as administrative burden of regulations. Ultimately, automation would ensure product quality and repeatability at a lower labor cost.

Submitted for peer review: Aug 24 2018
Published: Nov 20 2018
DOI: 10.18609/cgti.2018.087
Citation: Cell Gene Therapy Insights 2018; 4(9), 843-863.

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Augmenting Automated Analytics Using Fluorescent Nanosensors

Spotlight Article

Veeren M Chauhan

CRITICAL ROLE OF AUTOMATION IN THE MANUFACTURE OF CELL & GENE THERAPIES

Cell and gene therapies (CGTs) are projected to transform healthcare precision in the biotherapeutics sector. However, for their true potential to be realised, advancements must be made to optimising their manufacture, such that CGT production is precise, reproducible and robust. This includes monitoring and control of complex cell culture conditions, such as extracellular and subcellular biochemical parameters, for which there are no readily available automated analytical systems. Biosensors, such as fluorescent nanosensors, provide a tangible solution to augment CGT manufacture, as they enable off-line, online and inline monitoring of the cellular microenvironments. This expert insight highlights how the automated analytical afforded by fluorescent nanosensors, could permit real-time realignment of critical sub-cellular biochemical parameters to enhance CGT manufacture. The insight concludes by evaluating how the integration of fluorescent nanosensors with new and established methods could pave-the-way forward to maximise CGT potential.

Submitted for peer review: Sep 18 2018 Published: Nov 20 2018
DOI: DOI: 10.18609/cgti.2018.085
Citation: Cell Gene Therapy Insights 2018; 4(9), 837-850.
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