Choice in raw materials can have significant impact on the quality, efficacy, and safety of the final cell and gene therapy product. In this talk, we will explore the critical role raw materials play in process performance.

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Mayank Gupta - Product Specialist CMTSCCM, Product Excellence CMTS APAC, Sartorius

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The Linkit® AX solution was expertly designed to overcome the challenges of manual filling and aliquoting, without requiring investment in complex equipment. This advanced aseptic filling system efficiently channels process fluids into 10 Flexsafe® bags, enabling rapid and simultaneous filling. Its plug-and-play design, enhanced by a patented, ready-to-use bag distribution manifold, significantly reduces operator effort and error, ensuring precise fluid distribution into each of the 10 bags with an impressive accuracy of±5.1% (applicable for 250mL, 500mL, and 1000mL bags). This makes it an ideal solution for aliquoting small fluid quantities in applications such as small-batch media preparation for cell and gene therapy, as well as other process fluid aliquoting tasks.

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Clinton Simpson - Product Specialist, Product Excellence FMT APAC, Sartorius

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An automated, single-use solution designed to minimise contamination risks by reducing the need for manual handling. Ksep offers scalable counterflow continuous processing for aseptic cell concentration, wash, and harvest in cell therapy manufacturing, supporting high recoveries. By harmonizing a balance between centrifugal and fluid flow forces, it imparts very low shear on cells, ensuring high viability and yield. The automated cellwash feature enhances harvest quality in cell processing applications. TheKsep® system is adaptable from process development (0.1 L) to commercial manufacturing (200 L), providing seamless scalability.

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Amit Khanna - Manager of Product Excellence, ST APAC, Sartorius

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While several CAR-T cell therapies are already approved, patient access remains a fundamental challenge. How can manufacturing innovation enable better upstream yields and downstream recovery to reduce cost per dose? In this session we explore innovation at its best to improve plasmid engineering, transient lentivirus production as well as lentiviral purification performance with newly developed chemical modifications for functional CAR-Tcell generation.

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Blaz Bakalar - Product Manager, Sartorius

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A robust analytical tool delivering virus counts in near real-time. This system is adaptable across various virus growth and purification processes, offering versatility across numerous applications. Pinpoint optimal harvesting periods, validate processing stages, and establish final formulations efficiently and confidently. Viruses are labeled using specific reagents, employing either a direct dye method or high-affinity monoclonal antibodies. Subsequently, samples undergo precise and intense laser illumination. This method facilitates swift, direct, and precise quantification of total virus particles within a sample.

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Amit Khanna - Manager of Product Excellence ST APAC, Sartorius

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Abstract: The development of gene modified cell therapies, in particular chimeric antigen receptor (CAR) T-cell therapy, has revolutionized cancer treatment by enabling personalized intelligent medicine, with the potential to cure disease.

Owing to the success of CAR T-cell therapy, research in this field has boomed. Still, there are many limitations such as toxicity, limited efficacy against solid tumors, antigen escape, poor trafficking, and tumor infiltration that require to be addressed.

In order to overcome these significant challenges, innovative strategies and approaches to engineer more powerful CAR-T cells are necessary. In this talk, we will consider how by leveraging Incucyte®’s live-cell analysis and iQue®’shigh-throughput screener by cytometry platforms, researchers can be better equipped at assessing the criteria for developing and advancing future gene modified cell therapies.

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Nabiha Elias, PhD - BioA Field Application Specialist APAC, Sartorius

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