Case Study


Good Manufacturing Practices

“A statement that I often hear is “we need to do this to GMP” or “are the reagents GMP?”” says Zoe, CEO at Regenerative Cell Therapy Consulting.

Dr Zoe Hewitt has over 20 years of experience working with human Pluripotent Stem Cells. In 2006, as a recently qualified post doc, she was handed a newly built clean room and told to “make it work”. Now with over 15 years of experience developing Quality Management Systems, operating within a clean room environment and assisting with the early stages of cell therapy development, she shares her experience with others.

As pioneers of cell therapies, there is recognition that good manufacturing practises (GMPs) are expected by regulators and that they [GMPs] are there to make cell therapy products safe. However, there is significant confusion about how to assess whether GMPs are in place and what this actually means for the development of a cell therapy and its risk profile to a regulator.

The Challenge

It is clearly understood by developers that a cell therapy needs to be shown to be safe and efficacious to obtain regulatory approval for a clinical trial. What is less clearly understood, is the complex quality management requirements that a regulator will expect to see to support the safety and efficacy claims when they perform their assessment. 

Good manufacturing practises (GMPs) are a set of principles and guidelines which set out how products should be manufactured; controlled in accordance with quality standards, to ensure consistency and minimise risks. GMP regulations address issues including cleanliness, staff competence and training, record keeping, equipment verification, process validation and complaints procedures. However, just because something is consistent, doesn’t mean that it will not pose a risk to your product, and thus it is important to ask the right questions.


"A failure to capture quality data which articulates how processes have been developed, modified or controlled, can result in work having to be repeated and can be incredibly costly."

Zoe Hewitt, Co-Founder, CEO & QMS Specialist

Analyzing Our Problem

GMP regulations require a quality focused approach to the manufacture of a product. Ensuring that controls are being considered and those that can be controlled are being controlled, at an early stage, and providing supporting evidence of this, adds considerable value to your product development work. Adopting a quality management system early on in development will not only help to provide this, but will also assist with identifying issues with reproducibility, troubleshooting and problem solving, protocol optimisation and staff training and company resilience.


Assisting with the development of an agile Quality Management System, that is fit for the stage of development, i.e. it supports R&D progression whilst beginning to capture necessary translational data that will be required for regulatory consideration.

Translational considerations required for protocol development of cell therapies from research to a clinical development pipeline, such as supplier qualification and raw material selection.

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