Wednesday March 11Wednesday, 11 March 2026 - PT (Pacific Time, GMT-08:00)

• Engineering strategies for allogeneic CAR-T cell therapies for improved safety and efficacy
• Increasing scale of allogeneic cell therapies without compromising quality
• Improving access to CAR-T therapy with off-the-shelf products

• CAR T requires enhancement for improving efficiency
• T cell Engager as an enhancing feature of CAR T cells
• Rapid manufacturing of RNA based CAR T

• Discuss the challenges of external tech transfers when outsourcing CDMOs for clinical manufacturing.
• How to condense timelines and reduce costs through in-house utilization of AD/PD teams to perform parallel development with external partners.
• Strategies to identify and mitigate risks for allogeneic therapies.

• This talk will discuss critical attributes of AAV process development to bridge the gap for BLA and long-term commercial success.
• We will highlight key development differences among AAV vector manufacturing platforms, highlighting focus on development strategies for productivity, purity and safety.
• This presentation will offer actionable insights for BLA readiness in advancing AAV gene therapy products.

NIST reference materials for the biomanufacturing and biopharmaceutical industries.

In the last several years NIST has developed a number of reference materials (RMs) geared toward the biopharmaceutical industry. These include the NISTmAb, an NS0-produced IgG1k, the NISTCHO, a CHO cell line expressing the amino acid sequences of the NISTmAb, and the cNISTmAb, the product of the NISTCHO. All three RM materials are open access with minimal IP constraints to encourage open innovation and pre-competitive research. The properties of the RMs will be presented along with examples of how the community uses these materials.

A visionary panel on trends shaping the future: decentralized production, autonomous operations, evolving supply chains, and end-to-end continuous processes. Panelists will explore how digital and AI-enabled systems will define the next decade.

• Intensification strategies can transform biologics manufacturing, delivering both sustainability and cost-of-goods (CoGs) benefits.
• Case studies across antibodies and and RNA demonstrate how intensification can be applied to different product types.
• Intensification is not only about technical gains – it underpins more resilient, commercially viable, and environmentally responsible bioprocessing.

A forward-looking discussion on how continuous processing, single-use technologies, and AI/ML-enabled purification will transform downstream operations by 2030. Leaders will examine the convergence of sustainability, automation, and supply chain resilience as drivers of the next generation of biomanufacturing.

Presentations on innovative formulations, cryopreservation, and vector stabilization. Talks will highlight predictive modeling and data analytics for stability and manufacturability.

Panelists will discuss scaling CGT processes for launch, including validation, comparability, COGS, and supply chain readiness. Focus on digital readiness for regulatory filings and scale-up.