Large-Scale Cell Production Based on GMP-Grade Dissolvable Porous Microcarriers

The cell and gene therapy industry has witnessed an exponential expansion over the past two decades. However, a large technological gap exists between lab research and industrial skill manufacturing. Compliant with regulatory policies, and to meet the green demands of the CGT industry, automated closed systems have been adopted to produce cell therapeutics.

For adherent cells, cultivation using microcarriers in scalable stirred-tank bioreactors, is a promising method. Conventionally, commercialized microcarriers are non-desirable. Cell harvesting using trypsinization and the saving out microcarriers by size is not only inefficient and challenging, but also impacts cell quality and causes safety concerns.

In this study, we have successfully achieved large-scale cell production based on GMP-grade 3D TableTrix dissolvable microcarriers in an automated and closed system. Over 11 billion human mesenchymal stem cells were yield in a two-stage expansion within nine days. We also demonstrated high density culture of HEK293T cells and Vero cells, in which both densities reached above 10 million cells per milliliter.

This advanced biomanufacturing platform allows adherence cells to be effectively expanded and completely harvested in an automated and closed manner. Our protocol offers an opportunity to enhance production efficiency and refine quality control at industrial-scale manufacturing of CGT products.