Smart manufacturing for autologous cell therapies enabled by innovative biomonitoring technologies and advanced process control

Introduction

Autologous immunotherapies have revolutionised cancer treatment, providing impressive survival benefits in patients with blood cancers. The next generation of personalised immunotherapies using tumour-infiltrating lymphocytes (TIL) aims to overcome efficacy limitations of CAR-T therapies in the treatment of solid tumours.

Challenges in Manufacturing

Lack of effective, fast, adaptive, controllable, and scalable manufacturing processes remains one of the critical bottlenecks for the clinical adoption of such complex personalised cell therapies.

Project Overview

In the SMARTER project, Achilles Therapeutics UK Limited, a clinical-stage company developing autologous cell therapies, partners with the Centre of Excellence for Cell and Gene Therapy Catapult and academic experts in process biomarker discovery (Instituto de Investigacion Sanitaria La Fe) and bioprocess sensor development (Leibniz Universität Hannover).

Objectives

The consortium aims to develop a first-in-class, smart bioprocessing manufacturing platform for personalised autologous cell therapies. This will implement, for the first time, in-line process analytical technologies and smart process control systems.

Innovations

The project exploits breakthrough discoveries of novel T cell expansion process biomarkers and the development of new fluorescence spectroscopy sensors for real-time monitoring of critical process parameters. This will enable adaptive process control of the precision TIL biomanufacturing process.

Future Development

After the project, the prototype R&D platform will be ready for follow-up development of the commercial scale bioreactor in a GMP environment.

Expected Outcomes

The SMARTER platform will critically improve:

• Production efficiency
• Overall costs-of-goods
• Manufacturing cycle times (shorter vein-to-vein time)
• Decrease in batch failures
• More consistent and predictable cell therapy product quality

Finally, the innovations will enable clinical implementation of a potential breakthrough personalised adoptive cell therapy for the hardest-to-treat solid tumours such as lung cancer and melanoma.