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EMA, the European Drug Regulators, Publish Draft Guidance on Non-Clinical and Clinical Aspects of Medical Products Containing Geneticaly Modified Cells

admin — Sun, 25 Jul 2010 09:04:39 +0000

EMA, the European Drug Regulators, Publish Draft Guidance on Non-Clinical and Clinical Aspects of Medical Products Containing Genetically Modified Cells.

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This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans. Its focus is on the quality, safety and efficacy requirements of genetically modified cells developed as medicinal products.

genetically modified cells for treatment of monogeneic inherited disease;

genetically modified dendritic cells and cytotoxic lymphocytes for cancer immunotherapy;

genetically modified autologous chondrocytes for cartilage repair; genetically modified progenitor cells for cardio-vascular disease treatment or for in vivo marking studies, particularly for in vivo biodistribution or in vivo differentiation analysis;
−
genetically modified osteogenic cells for bone fractures repair; genetically modified cells for 66 infectious disease treatment.
This guideline defines scientific principles and provides guidance to applicants developing medicinal products containing genetically modified cells. It is recognised that this is an area under constant development and guidance should be applied to any novel procedures as appropriate.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA, the European Drug Regulator publishes, Draft Guideline on Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.

admin — Mon, 12 Jul 2010 10:55:09 +0000

EMA, the European Drug Regulator publishes, Draft Guideline on Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.

Full text Here

Genetically modified cells may be developed either for therapeutic use (gene therapy medicinal products) or to use the genetic modification in the manufacturing process of a cell therapy / tissue engineering product.
The following are some examples of medicinal products containing genetically modified cells (GMC) that have been used in clinical trials:
− genetically modified cells for treatment of monogeneic inherited disease;
− genetically modified dendritic cells and cytotoxic lymphocytes for cancer immunotherapy;
− genetically modified autologous chondrocytes for cartilage repair; genetically modified progenitor cells for cardio-vascular disease treatment or for in vivo marking studies, particularly for in vivo biodistribution or in vivo differentiation analysis;
− genetically modified osteogenic cells for bone fractures repair; genetically modified cells for infectious disease treatment.
This guideline defines scientific principles and provides guidance to applicants developing medicinal products containing genetically modified cells. It is recognised that this is an area under constant development and guidance should be applied to any novel procedures as appropriate.

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Drug Regulators, EMA (EMEA), Publish Reflection Paper on in-vitro Cultured Chondrocyte Containing Products for Cartilage Repair of the Knee

admin — Sun, 30 May 2010 08:35:21 +0000

Drug Regulators, EMA (EMEA), Publish Reflection Paper on in-vitro Cultured Chondrocyte Containing Products for Cartilage Repair of the Knee

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This reflection paper addresses specific points related to medicinal products containing in vitro cultured autologous chondrocytes intended for the repair of cartilage lesions of the knee. This reflection paper is considered to supplement the ‘Guideline on human cell-based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline.

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Drug Regulators, EMEA, Publish Guidline on Xenogenic Cell-Based Medicinal Products

admin — Thu, 31 Dec 2009 07:56:30 +0000

Drug Regulators, EMEA, Publish Guidline on Xenogenic Cell-Based Medicinal Products

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Xenogeneic cell-based therapy is the use of viable animal somatic cell preparations, suitably adapted for: (a) implantation/ infusion into a human recipient or (b) extracorporeal treatment through bringing (non-human) animal cells into contact with human body fluids, tissues or organs. The principal objective is reconstitution of cell/tissue/organ functions. The genotype and/or phenotype of the cells may have been modified, e.g. by isolation, culture, expansion, pharmacological treatment or
combination with various matrices. This guideline is an annex to the guideline on cell-based medicinal products (EMEA/CHMP/410869/2006) and deals specifically with requirements unique to xenogeneic specificities. This document is intended to provide general principles to be taken into consideration for the development and assessment of xenogeneic cell-based products without prejudice to medical practice or national legislation, which may be applicable. The main scientific and technical issues identified so far concern the sourcing and testing of animals, manufacture, quality control, as well as the non-clinical and clinical development of xenogeneic cellbased medicinal products are addressed. Relevant public health aspects are discussed and measures to ensure a proper surveillance for infections, including zoonoses are highlighted. These general
principles may apply to a range of products using animal tissues as the starting material, as the key objective is to ensure that the product to be administered is of acceptable quality and standard, and free from contamination.
The additional risks associated with xenogeneic cell-based Medicinal Products should be taken into account in the clinical development of these products. Attention is also given to principles of animal health and welfare in the processes of sourcing of xenogeneic materials for the medicinal products intended for human use.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

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Drug Regulatos Publish Draft Reflection Paper on In-vitro Cultured Chondrocyte Containing Products for Cartilage Repair

admin — Tue, 03 Nov 2009 16:41:12 +0000

Drug Regulators, EMEA, Publish Draft Reflection Paper on In-vitro Cultured Chondrocyte Containing Products for Cartilage Repair

full text here

This reflection paper addresses specific points related to products containing autologous chondrocytes intended for the repair of lesion of cartilage of the knee not discussed in the ‘Guideline on human cell based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline. – Deadline for comments is 31st December 2009.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap

recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.