Speakers

• Mark Dowling, MBBS, PhD, Clinical Haematologist, Peter MacCallum Cancer Centre, Melbourne, Australia
• Robert Weinkove, MBBS, PhD, Clinical Director, Malaghan Institute of Medical Research, New Zealand
• Gemma Reynolds, MBBS, MPH, Infectious Diseases Physician, Austin Health, Australia

Presentation Abstract

This session will examine how immunotherapies are performing in real world clinical settings, with insights from registry data, national consortia, and clinical experience. Speakers will explore effectiveness, safety, patient selection, and health system challenges to understand how outcomes in practice compare with clinical trial expectations.

Session Objectives

1. Analyse real-world data on immunotherapy outcomes, including effectiveness, durability, and safety across diverse patient
populations.
2. Understand how registry and consortium data are informing clinical decision-making and health policy.
3. Identify key factors influencing real-world outcomes, including patient selection, toxicity management, and service delivery
models.
4. Discuss strategies to optimise access, equity, and long-term outcomes for immunotherapy in routine clinical practice.

Speaker

• Rukmini Ladi, Segment Technology Manager, Cell Therapy, Sartorius

Presentation Abstract

To realize the potential of CAR-T therapies for broader patient accessibility, current manufacturing limitations of approved autologous CAR-T products must be addressed. To this end, we evaluated a perfusion-based autologous CAR-T expansion process in both 250 mL and 2L stirred-tank bioreactors, coupled with an automated system for harvest, wash, and concentration. Healthy donor-derived
anti-CD19 CAR-T cells were cultured in serum-free medium for seven days, achieving ~125-fold expansion and consistent yields of ~50 billion viable cells with preserved phenotype and functionality. Comparability was observed between both production scales, and automated harvesting recovered >90% of cells while maintaining quality. These findings demonstrate a robust, scalable platform for multi-liter CAR-T manufacturing, ideally suited for mass production of future allogeneic therapies.

Speaker

• Lumeng Ye, PhD, Head of Business Development, ANZ, GenScript Biotech Australia Pty. Ltd., Australia

Presentation Abstract

In the past two years, in vivo CAR-T therapy moved fast from conceptual and NHP data to 100% ORR human clinical data. More and more practical understanding on the design of targeted delivery approach and CAR molecule format, reported with proven clinical data. Currently, both viral vector and LNP delivery were reported with promising targeted and efficient delivery, with the right antibody decoration. In this 15 minutes presentation, we will take the non-viral LNP approach as example, elucidate the best practice on CAR design, LNP formulation, choices of antibody for target delivery, to maximize the treatment effect of in vivo CAR-T therapy in systematic manner.

Session Objectives

1. Choices on the payload design and format for targeted and long expression of CAR modality
2. Best combination of LNP formulation and antibody conjugation for targeted delivery to spleen and T cell
3. Considerations on CMC of tLNP-RNA/DNA solution for in vivo CAR-T development
4. Total solution from GenScript for in vivo CAR-T therapy development

Speaker

• Kevin McSharry, VP Practice Lead, Quality, Ideagen, Australia

Presentation Abstract

If you've worked with Ideagen's quality platform before, you'll know it as Q-Pulse. In this session, Kevin McSharry, who leads Ideagen's Quality practice, shares what's changed, what hasn't, and what's coming next for cell and gene therapy manufacturers, laboratories and clinical trial sponsors across Australia.

Ideagen remains deeply invested in supporting ANZ organisations navigating ISO 13485, NATA accreditation and TGA compliance, with a local team who understand the regulatory landscape you work in.

Kevin will also demonstrate how Ideagen's AI capabilities are already cutting the manual effort out of quality management, from drafting investigations to tracking corrective actions to closure. 

Whether you're a long-time customer or exploring a new QMS, this is a chance to see what's next and talk directly with the team building it.

Session Objectives

1. Understand what's changed (and what hasn't) since Q-Pulse became Ideagen Quality Management, and what local support looks like today
2. See how peer organisations across Australia's cell and gene therapy sector are managing ISO 13485, NATA accreditation and TGA compliance
3. Learn how AI is being used to cut manual effort out of quality processes, from investigations to corrective action tracking

Speaker

• Andrea Zhao, PhD, Application Specialist - Cell Therapy & Nanomedicine, Cytiva, Sydney, Australia

Presentation Abstract

This presentation outlines Cytiva’s integrated platforms for end-to-end cell therapy manufacturing, spanning from PBMC isolation and T cell enrichment, activation, expansion, and downstream harvesting, formulation, and cryopreservation. We will describe industry validated suspension culture systems widely deployed in CAR T and other immunotherapy workflows, emphasizing closed processing, process control, and scalability in bioreactor-based expansion. In addition, we will introduce the Sefia™ platform, including Sefia Select for automated cell enrichment and Sefia Expansion for controlled, scalable proliferation within a closed architecture. In parallel, we will showcase non-viral cell engineering approaches using Cytiva lipid nanoparticle (LNP) technologies, with data demonstrating efficient delivery and compatibility with closed, modular manufacturing workflows.

The second part focuses on a scalable, fully closed and automated adherent cell manufacturing workflow integrating Cytiva platforms with CellFiber™ scaffold technology for MSC and iPSC expansion. This system enables high-density 3D culture under controlled conditions while maintaining critical quality attributes. A key innovation is the harvest mechanism, where controlled dissolution of the
scaffold replaces enzymatic detachment, eliminating open handling steps. This approach improves cell recovery, preserves viability, and enhances process consistency and scalability, supporting robust, GMP-aligned manufacturing across adherent cell therapy applications.

Session Objectives

1. End-to-End, Modular, and Closed Manufacturing Platform from research to translation and commercial manufacturing.
2. Next-Generation Processing with Sefia™ and Non-Viral LNP Technologies.
3. Scalable, Fully Closed Adherent Cell Manufacturing with CellFiber™ Integration.

Speaker

• Ryan Tay, PhD, Commercial Lead APAC, Cell Signaling Technology, Singapore

Presentation Abstract

Chimeric Antigen Receptor (CAR)-T cell therapy is a highly innovative form of immunotherapy that has proven to be successful in treating hematologic malignancies. As this therapeutic modality continues to evolve toward the targeting of novel combinations of tumor antigens and the development of more efficacious CAR-T cells, there is a need for tools that can be leveraged to selectively manipulate CAR-T cells in preclinical research workflows. Here, we report on a novel and highly versatile recombinant monoclonal antibody raised against the Gly4Ser (G4S) peptide linker, which is commonly integrated into single-chain variable fragment (scFv)-based CARs. Our data demonstrate the utility of an anti-G4S linker monoclonal antibody for the isolation of CAR T cells, which eliminates the need for a co-expressed marker for selection. Furthermore, this antibody can be leveraged in flow cytometry assays
to provide a direct measure of the surface expression of G4S-linker-containing CARs, independent of CAR specificity. The versatile attributes of the anti-G4S linker monoclonal antibody warrant further investigation aimed at the development of more standardized CAR-T workflows, thereby eliminating custom reagent development across multiple programs with unique CAR designs.

Session Objectives

1. The anti-G4S antibody represents a platform-enabling tool for CAR-T workflows rather than a program-specific reagent.
2. Adoption of this strategy can streamline the development of CAR-T therapies, reducing variability and operational burden.
3. Development of GMP-grade antibody conjugates supports standardized, regulatory-compliant processes for cell therapy production.
4. This approach eliminates custom reagent development for each new CAR construct, saving time and cost.
5. Broad applicability across CAR designs positions this tool as a scalable solution for next-generation and multiplexed CAR-T therapies.

Speaker

• Catherine Cole, MBBS FRACP FRCPA, Chief Medical Officer, NeuroScientific Biopharmaceuticals Ltd, Australia

Presentation Abstract

NeuroScientific Biopharmaceuticals Ltd (ASX:NSB) is developing the StemSmart™ mesenchymal stem cell technology platform derived from a patented manufacturing process resulting in activated MSCs. StemSmart™ has significant early-stage clinical trial and Special Access Scheme data in humans that demonstrates its significant impact on immune-mediated inflammation. NSB is progressing towards Phase 2 clinical trials in Crohn’s disease off the strength of this data, with plans to initiate by the end of 2026.

Session Objectives

1. Overview of MSC technology and what differentiates StemSmart™ from the rest of the product class
2. Why StemSmart™ MSCs are an effective in Crohn’s disease and other immune-mediate inflammatory diseases
3. Overview of the upcoming clinical trials in Crohn’s disease and the future of the StemSmart™ platform.

Speaker

• Poh Loong Soong, PhD, Field Application Scientist, Cell and Gene Advanced Therapy, Asia Pacific and Japan, Thermo Fisher Scientific, Singapore

Presentation Abstract

As engineered cell therapy pipelines broaden, manufacturing processes must be able to manage variability in cell type, target dose, final formulation volume, and fill format. Manual processing and fill finish operations can contribute to process variability, contamination risk, and workflow inefficiency, especially in multi-step autologous manufacturing. Closed, automated, and modular systems provide a strategy to improve reproducibility and scalability while maintaining product quality. This study assessed an integrated modular workflow that combines automated cell concentration and washing with automated formulation and fill–finish for multiple CAR-engineered cell therapy models and clinically relevant dose configurations.

Session Objectives

1. Learn how automated cell concentration, washing, formulation, and fill-finish operations can be integrated into a seamless end to end workflow.
2. Explore strategies for maintaining critical quality attributes, including cell recovery, viability, and phenotype, throughout downstream processing.
3. Review performance data demonstrating accurate and consistent dispensing across a wide range of fill volumes and product configurations.
4. Examine how automated fill-finish solutions can support multi-dose, multi-output, bag and vial formats while reducing process variability and contamination risk.