Manufacturing – VJRegenMed

Phase I study of rapcabtagene autoleucel in patients with R/R DLBCL

Anya Kerkache — Thu, 09 Mar 2023 11:31:46 +0000

Nirav Shah, MD, Medical College of Wisconsin, Milwaukee, WI, gives an update on a Phase I study of rapcabtagene autoleucel in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Dr Shah explains that this next-generation CD19 CAR-T therapy has been manufactured using T-Charge, which allows this product to be manufactured faster than other CAR-T therapies, thus helping it to preserve T cell stemness, decrease the dose of infused CAR-Ts, and increase its overall quality. The study identified a safe dose level for further investigations and reported low rates of cytokine release syndrome (CRS). This interview took place at the 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR® held in Orlando, FL.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.

Rapid CAR-T manufacturing and challenges in this space

Anya Kerkache — Wed, 08 Mar 2023 10:35:16 +0000

Nina Worel, MD, Medical University of Vienna, Vienna, Austria, shares some insights into challenges with CAR-T manufacturing, explaining that even rapid manufacturing processes may require patients to wait up to four weeks before they can receive treatment. This interview took place at the EBMT-EHA 5th European CAR T-cell Meeting held in Rotterdam, The Netherlands.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.

Results from a Phase I trial of rapidly manufactured Prgn-3006 Ultracar-T in R/R AML

Anya Kerkache — Thu, 26 Jan 2023 12:11:28 +0000

In this video, David Sallman, MD, Moffitt Cancer Center, Tampa, FL, outlines the completed Phase I results for Prgn-3006 Ultracar-T in patients with relapsed/refractory (R/R) CD33+ acute myeloid leukemia (AML). Prgn-3006 Ultracar-T is an autologous CAR-T cell product with decentralized manufacturing that significantly reduces the time between apheresis and CAR-T infusion compared to standard autologous CAR-T therapies. Overall, results suggest that Prgn-3006 Ultracar-T is well tolerated, with only a few grade 3 cytokine release syndrome (CRS) events and no dose-limiting toxicities. This interview took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.

Phase I study of CC-98633 in R/R multiple myeloma

Anya Kerkache — Thu, 26 Jan 2023 12:11:26 +0000

In this video, Luciano Costa, MD, PhD, UAB School of Medicine, Birmingham, AL, shares some results from a Phase I study evaluating CC-98633, a next-generation BCMA-targeting CAR-T cell therapy, in patients with relapsed/refractory (R/R) multiple myeloma (NCT04394650). Dr Costa first highlights the NEX-T manufacturing process used to develop this agent, and then discusses the activity and safety of this agent as demonstrated in the study. This interview took place at the 64th ASH Annual Meeting and Exposition congress held in New Orleans, LA.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.

Streamlining cell therapy manufacturing with CliniMACS Prodigy

Simon Ng — Thu, 28 Apr 2022 08:38:41 +0000

Saskia Rösch, PhD, Miltenyi Biotec, Bergisch Gladbach, Germany, gives an overview of CliniMACS Prodigy, a novel next-generation automated cell processing platform that aims to separate and process cell cultures for the manufacturing of cell therapies. The closed, scalable system enables the production of good manufacturing practice (GMP) compliant products of consistent quality in a safe and clean environment. CliniMACS Prodigy additionally is flexible in a centralized or decentralized setting and can be used for various cell types including induced pluripotent stem (iPS) cells, chimeric antigen receptor (CAR) T-cells and natural killer (NK) cells. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

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.

Addressing challenges in using MSCs in cell therapies

Simon Ng — Thu, 21 Apr 2022 15:04:28 +0000

Mesenchymal stem cells (MSCs) have demonstrated potential in cell therapies, as they have unique immunomodulatory properties. Ross Macdonald, PhD, Cynata Therapeutics, Melbourne, Australia, comments on the hurdles in commercializing MSC-based cell therapies. Unlike autologous chimeric antigen receptor (CAR) T-cell therapies, MSCs are derived from allogeneic sources, which in itself presents logistical issues in terms of obtaining enough donors. Cell expansion for commercial usage additionally is an issue, as MSCs become less potent as they expand, and Dr Macdonald presents solutions offered by Cynata Therapeutics that attempt to overcome the aforementioned barriers. This interview was conducted during Meeting on the Mediterranean 2022.

Generating iSPC-derived MSCs with the Cymerus™ Platform

Simon Ng — Thu, 21 Apr 2022 15:04:27 +0000

Ross Macdonald, PhD, Cynata Therapeutics, Melbourne, Australia, discusses the process of manufacturing mesenchymal stem cells (MSCs) derived from induced pluripotent stem cells (iPSCs) with the Cymerus Platform. MSCs have shown encouraging efficacy as cell therapies and using iPSCs enables the MSCs to remain potent, as they do not require expansion. The iSPCs also do not require multiple donors as they can replicate indefinitely, resulting in MSCs of a consistent quality. This interview was conducted during Meeting on the Mediterranean 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.