Allogeneic cell therapy manufacturing: process development technologies and facility design options

ABSTRACT

Introduction: Currently, promising outcomes from clinical trials of allogeneic cells, especially allogeneic mesenchymal stromal cells, fibroblasts, keratinocytes, and human cardiac stem cells, have encouraged research institutions, small and medium enterprises (SMEs), and big pharmaceutical companies to invest and focus on developing allogeneic cell therapy products. Commercial and large-scale production of allogeneic cell therapy products requires unique capabilities to develop technologies that generate safe and effective allogeneic cells/cell lines and their fully characterized master/working banks. In addition, it is necessary to design robust upstream and downstream manufacturing processes, and establish integrated, well-designed manufacturing facilities to produce high quality affordable products in accordance with current GMP regulations for the production of cell therapy products.

Areas covered: The authors highlight: the recent advances in the development of allogeneic products, the available options to develop robust manufacturing processes, and facility design considerations.

Expert opinion: Currently, there are multiple challenges in development of allogeneic cell therapy products. Indeed, the field is still in its infancy; with technologies and regulations still under development, as is our understanding of the mechanisms of action in the body and their interaction with the host immune system. Their characterization and testing is also an emerging and very complex area.

KEYWORDS:

• Allogeneic cell therapy
• commercialization
• process development
• facility design

Article highlights

• Allogeneic cell therapy has emerged very fast during recent years in terms of science, technology and commercialization, while about 50 percent of products under phase III of clinical investigation and pre-registration stage are designed for allogeneic application.

• To date, different strategies have been developed for generation cell sources for allogenic cell therapy application. However, choosing a proper strategy is critical and largely depend on the initial donor/tissue/cell type, desired product quality attributes, and targeted commercial application.

• There is a limited expertise in commercial and large scale manufacturing of allogeneic cell therapy products since most of the products under development and few products are approved.

• Most of current processing technologies for large scale manufacturing of cell based therapeutic for allogeneic application suffering from critical limitations in scalability and/or productivity

• Allogeneic cell therapy manufacturing facility design and choosing a proper business plan is a critical decision making process that largely affect the commercial success of the product and its widespread commercial application

This box summarizes key points contained in the article.

Declaration of interest

H Baharvand is an advisor for Cell Tech Pharmed. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This work was supported by a grant from Royan Institute, the Iran National Science Foundation (INSF), the and the National Institute for Medical Research Development (NIMAD) no. 942101.