Automation – VJRegenMed

Implementing automation technology in the CGT space

Simon Ng — Thu, 28 Apr 2022 08:38:40 +0000

The advent of automation has brought improvements in the manufacturing of advanced therapies in terms of reducing the number of staff needed, cost, and safety. Saskia Rösch, PhD, Miltenyi Biotec, Bergisch Gladbach, Germany, discusses potential barriers developers might face in automating their manufacturing processes. Companies will need to make sure the product can be translated from a research to clinical setting, as well as if the reagents can be scaled-up if necessary. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

Utilizing flow cytometry in CAR T-cell research

Simon Ng — Thu, 28 Apr 2022 08:38:38 +0000

Saskia Rösch, PhD, Miltenyi Biotec, Bergisch Gladbach, Germany, comments on the importance of flow cytometry in the characterization of chimeric antigen receptor (CAR) T-cells. Standardization of flow cytometry techniques is necessary to optimize CAR T-cell therapies, and Dr Rösch discusses automated workflow solutions offered by Miltenyi, as well as CAR detectors that can quantify CAR T-cells in a given sample. She additionally highlights a consortium that will create a gold standard for the analysis of engineered CAR T-cells. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

Overcoming manufacturing issues in gene therapies for rare diseases

Simon Ng — Wed, 20 Apr 2022 16:45:46 +0000

John Maslowski, CCO, Forge Biologics, Columbus, OH, discusses strategies to optimize the manufacturing of gene therapies for rare diseases. In addition to regulatory barriers, maintaining the consistency of the product is vital, especially when manufacturing occurs in large-scale bioreactors. To ensure the cost of production remains low and the patients’ needs are successfully met, he emphasizes the need to use automated analytical tools in a closed system. Assessing product quality via high throughput systems can expedite production times on a larger scale. This interview took place at Advanced Therapies Week 2022.

Innovations in treating rare diseases with gene therapies

Simon Ng — Wed, 20 Apr 2022 16:45:46 +0000

John Maslowski, CCO, Forge Biologics, Columbus, OH, comments on the current treatment landscape for rare diseases, especially in the field of gene therapies. With a large number of rare diseases lacking any form of treatment, finding curative solutions for these rare diseases remain an unmet need. Finding a suitable clinical model is essential to develop treatments, especially when the natural history group in a clinical trial is preferable to placebo groups, as in the case of studies targeting Krabbe disease. Introducing closed automated systems in the manufacturing process will additionally enable the production of gene therapies in an economical manner. This interview took place at Advanced Therapies Week 2022.

Meeting the growing demand for gene therapy manufacturing

Simon Ng — Wed, 20 Apr 2022 16:45:45 +0000

John Maslowski, CCO, Forge Biologics, Columbus, OH, gives an overview of Forge Biologics’ plans to meet the increasing demand for gene therapies. The recent $80 million expansion of the manufacturing facilities at Forge Biologics with automated components and clean rooms will enable global expansion. Additional recruitment of personal and inhouse analytical services will also enhance current adeno-associated virus (AAV) vector production capabilities. This interview took place at Advanced Therapies Week 2022.

Advances in T cell metabolic profiling

admin_vjr_user — Fri, 01 Apr 2022 08:06:08 +0000

Daniel Gebhard, PhD, Agilent Technolgies, Efringen-Kirchen, Germany, describes his presentation at the International Conference on Lymphocyte Engineering (ICLE) 2022 on advances in T cell metabolic profiling and how analytical tools can help optimize CAR T cell characterization during production and development. He introduces an analyzer from Agilent Technologies designed to measure low cell numbers, which can be beneficial when studying rare T cell subsets. He also describes a 96-well plate system developed in view of CAR T cell production, as well as a T cell metabolic profiling kit that measures metabolic parameters for T cell characterization including information on mitochondrial capacity, ATP production and glycolysis. This interview took place ICLE 2022.

Adapting to challenges in manufacturing cell therapies for solid tumors

Simon Ng — Thu, 03 Mar 2022 17:46:20 +0000

Whilst chimeric antigen receptor (CAR) T-cell therapies have been successful in hematological malignancies, solid tumors remain an unmet need especially in patients with colorectal cancer. Christopher Ballas, PhD, Innovative Cellular Therapeutics, Rockville, MD, describes strategies to increase the production of CAR T-cell therapies for solid tumors. Decentralized manufacturing and automation will enable therapies to be produced in a shorter timeframe, improve quality control, and facilitate the regulatory process. However, logistics and cost are issues that still need to be addressed. This interview took place at Advanced Therapies Week 2022.

The role of automation in manufacturing CAR T-cells

Simon Ng — Wed, 02 Mar 2022 11:58:17 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, discusses advances in chimeric antigen receptor (CAR) T-cell therapy manufacturing, including developments in automation and shortened T-cell culture. Whilst a 24 hour manufacturing process has been in development, further research is required to assess feasibility. Dr Levine also describes T-Charge, a less labor-intensive novel CAR T-cell platform that expedites the culture time, requiring fewer reagents as a result. This interview took place at Advanced Therapies Week 2022.

Strategies to increase cell therapy manufacturing capabilities

Simon Ng — Mon, 28 Feb 2022 17:56:22 +0000

Shannon Eaker, PhD, Cytiva, Marlborough, MA, describes important considerations when aiming to expand the capabilities of cell therapy manufacturers, including the need to increase recruitment and training of highly skilled workers as well as retaining existing workers. Dr Eaker additionally highlights constraints in the supply chain, and factoring in the scalability of a product in its design. The advent of automation and digitization in the form of electronic batch records will also aim to address the aforementioned issues by streamlining the manufacturing process. This interview took place at Advanced Therapies Week 2022.

Addressing issues in patients accessing advanced therapies

Simon Ng — Thu, 24 Feb 2022 11:16:27 +0000

Jason Foster, MBA, Ori Biotech, London, UK, discusses barriers facing patients access to cell and gene therapies as well as solutions to address these challenges. Collection of patient cells increases the complexity of the supply chain, with increased travel and cryopreservation costs needed for the product. Large-scale manufacturing advanced therapies is additionally challenging due to the inconsistent nature of the starting material, as well as the need for personnel with a specialized skillset. Multiple strategies such as automation and decentralized approaches may provide a solution to these issues. This interview took place at Advanced Therapies Week 2022.