Moving from the lab to the clinic: Why cGMP is key in raw materials a work in progress..

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For many laboratory researchers, the transition from pre-clinical development to clinical application is either an afterthought or a convoluted, documentation-riddled process. Yet cGMP-compliant manufacturing processes should be at the core of any product development campaign, as good planning can make an otherwise extensive process significantly more straightforward. Good planning starts from the beginning: the selection of raw materials. Because researchers are ultimately responsible for the quality of the final product, traceability and quality of raw materials are key. Since the FDA does not regulate raw materials, but rather final products, researchers are responsible for ensuring final product quality standards are achieved through a combination of raw material quality and process compliance. As Akron Biotech CEO Claudia Zylberberg, Ph.D, put it in a recent interview with Stem Cell Assays, “By selecting raw materials early and verifying the availability, consistency, traceability, toxicity and contaminant studies, you control the risks of variability in effectiveness downstream. A qualification process and on-site audit brings confidence and closeness in the relationship with your materials and reagents manufacturer that supports systems, process modifications, and regulatory compliance.”

But that’s not all. cGMP manufacturing compliance is part of a larger Quality Assurance program that also requires compliance of other aspects of the manufacturing process:

  • intermediate and end-products
  • in process controls
  • extensive process documentation and validation
  • product identity, packaging and transport
  • personnel training

For tissue-engineered products, GMP regulations apply to all phases of product development, including tissue collection, cell and tissue processing and expansion, and storage.

A helpful overview of such guidelines and the current status of the ongoing efforts on the regulatory space are given in “Raw Materials for production of cell-based and gene therapy products” a report by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe and the European Medicines Agency (EMA) last April in France, and initiatives from USP such as “Cell  and Gene Therapy Products” on Chapter <1046>  and “Ancillary Materials for Cell, Gene and Tissue-Engineered Products” on < Chapter 1043>

As Sophie Bisson describes in her latest article published last month “Raw materials intended to be used for Gene, Cell and Tissue therapies: legal and regulatory considerations” harmonization and the production as well as the trade of raw materials to advance therapies is a “work already in progress”.
For a lot of researchers, compliance is not a straightforward path to take. Companies like Akron Biotech are here to support and assist in such endeavors. At Akron we are happy to assist with the transition from research to clinical grade, by optimizing the process and reducing the cost of increased testing, validation and process controls by analyzing steps, process and logistics.

One thought on “Moving from the lab to the clinic: Why cGMP is key in raw materials a work in progress..

    Dr.Gyana Ranjan Padhy said:
    January 28, 2014 at 1:56 am

    The method displayed will be highly benificial to SICKLE CELL DISEASE cases.
    Dr.Gyanaranjan Padhy M.D.(Medicine)
    Director-Sickle cell disease and other Haemoglobinopathies research project
    S.R.Medical college

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