[WEBINAR] Accelerating ATMP Development: From Lab to GMP

In this on-demand webinar, The Medicine Accelerator explores how ATMP programs can move from lab-scale development toward GMP manufacturing with stronger process understanding, clearer quality controls, and fewer scale-up surprises.

The session focuses on a case study in oncolytic virus development, where targeted upstream and downstream process improvements supported a 400% increase in viral yield and a 90% reduction in cost per dose.

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Advancing ATMPs from Promise to Manufacturable Therapy

Advanced Therapy Medicinal Products, or ATMPs, are changing what is possible for patients with cancer and other serious diseases. Oncolytic viruses are one example, offering a therapeutic approach designed to selectively infect and kill cancer cells while stimulating an immune response.

Many ATMP programs face pressure as they move beyond early development. Processes that perform well at lab scale may not be ready for GMP. Yield may be too low. Impurity profiles may be difficult to control. Unit economics may not support broader patient access. Analytical methods, documentation, and transfer packages may not yet be strong enough for the next phase of development.

For many programs, these issues become visible around Phase 2, when demand, regulatory expectations, and manufacturing complexity all begin to rise.

Designing for Manufacturability Earlier

ATMP development cannot be separated from manufacturing strategy. The process needs to support product quality, patient demand, regulatory expectations, and cost of goods.

This webinar looks at how process design decisions can help address common ATMP bottlenecks before they become late-stage constraints. That includes upstream yield improvement, downstream impurity reduction, process scalability, GMP readiness, and technology transfer.

The goal is not only to increase output. It is to build a process that can be controlled, repeated, documented, and transferred.

The Case Study: Improving Yield and Cost per Dose

In the featured case study, the presenter discusses the development goals, process design, regulatory considerations, and technology transfer requirements behind an ATMP manufacturing program.

The work delivered meaningful process improvements, including:

• A 400% increase in viral yield

• A 90% reduction in cost per dose

• Improved impurity profiles

• A more robust and scalable process

• A clearer route from lab development toward GMP manufacturing

For ATMP developers, these outcomes matter because yield, quality, and cost are closely connected. Improving one part of the process without understanding the broader manufacturing impact can create new constraints elsewhere. A stronger development strategy looks across the full process and builds the evidence needed to support scale-up, compliance, and patient supply.

What the Webinar Covers

• Process design for ATMP manufacturing. Learn how early process decisions can shape yield, quality, scalability, and GMP readiness as ATMP programs move beyond the lab.

• Manufacturing bottlenecks and quality risks. Explore common points where ATMP programs can stall, including low productivity, impurity challenges, process variability, and incomplete transfer readiness.

• Regulatory and technology transfer considerations. Understand why manufacturability, compliance, documentation, and process understanding need to be built into development before GMP transfer.

From Lab-Scale Success to GMP Readiness

A lab-scale process can show that a therapy is technically possible. GMP manufacturing has to show that the process can be run with control.

For ATMP teams, that means asking practical CMC questions early:

• Can the process deliver enough material to meet patient demand?

• Are the key impurities understood and controlled?

• Can yield be improved without compromising quality?

• Is the process scalable and repeatable?

• Are the analytics suitable for development and transfer?

• Is the documentation strong enough to support GMP readiness?

The earlier these questions are addressed, the easier it is to avoid rework, delays, and cost pressure later in development.

Supporting Faster Time to Patient

For ATMPs, process development is directly tied to patient access. A therapy cannot reach more patients if the process cannot scale, if cost per dose remains too high, or if quality risks delay transfer into GMP manufacturing.

This webinar shows how an integrated CMC approach can help ATMP developers improve yield, reduce cost, strengthen quality, and shorten the path from lab to GMP.