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A proposal to align release standards for transfection reagents

9 January 2024
Advanced Therapy Medicinal Products
Supply Resilience
A proposal to align release standards for transfection reagents
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227 downloads

Cell and gene therapy (CGT) represents a novel and growing class of innovative products that often have complex manufacturing processes. In many cases, genetic material is introduced into eukaryotic cells via transient transfection, which is a crucial manufacturing step.

However, due to inherent complexity and criticality, there is an acute need for a standardized approach for certifications of analysis of chemical transfection reagents used in good manufacturing processes. This paper proposes a way to align release standards for transfection reagents.

An agreed framework for release testing polymer-based transfection reagents has many benefits. It will give you confidence that your actions are aligned with those of your peers and alignment will bring reliability and consistency to the manufacturing process as everyone can meet the same standard for a particular material.

It will also mean that manufacturers, suppliers, and clients can use the same language and refer to an agreed reference table and testing. Importantly, when you file with regulatory authorities, you will have a data pack covering what they expect to see and demonstrating that you are managing and controlling that material appropriately.

Nobody has tried to define the polymer-based transfection reagent release testing needed for CGT processes, so the BioPhorum approach is an industry first.

Readers are invited to comment on the specific standards, tests, and the overall proposed approach. Feedback can be provided by completing this form.

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

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