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apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs).
(116.) EMA/75786/2014, Scientific Recommendation on Classification of Advanced Therapy Medicinal Products Article 17--Regulation (EC)1394/2007, 20.01.2014
Indeed, raw materials that are intended to be used during manufacturing operations of advanced therapy medicinal products are subject to the requirements laid down in the EU pharmaceutical legislation, while developers of gene, cell and tissue therapy products that only consist of minimally prepared human cells or tissues, in line with Directive 2004/23/EC, are not obliged to comply with- but may refer to--these requirements.
(2.) Committee for Advanced Therapies et al., "Challenges with Advanced Therapy Medicinal Products and How to Meet Them," Nature Review Drug Discovery 3 (2010): 195-201.
The guidance will especially give advice on the manufacture of new product types such as transgenic-derived medicines and advanced therapy medicinal products. It will be incorporated as an annex to the EU's general Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and will provide detailed advice and information on handling biological active substances prior to being rendered sterile; and subsequent manufacturing steps.
Advanced therapy medicinal products and related treatments which involve intervention in gene therapy, cell therapy and tissue engineering are of a major importance, having great potential in the treatment of diseases such as cancer, cartilage or bone diseases and injuries, repair of genetic disorders, repair of post heart attack damage or skin replacement in burned victims.
(157) Marketing authorizations for advanced therapy medicinal products will be dealt with under the centralized procedure, with the EMEA consulting a newly established Committee on Advanced Therapies in its evaluation of a product.
The iPSCs will provide a suitable starting material for a number of advanced therapy medicinal products (ATMPs) that offer ground breaking opportunities for the treatment of life-changing and life-threatening disease and injury, including those where patients' needs are currently unmet
PharmaCell was primarily selected due to its core expertise in autologous cell and gene therapy manufacturing, which includes experience with two commercial advanced therapy medicinal products (ATMPs)-licensed products.
Hospital exemption allows advanced therapy medicinal products to be made available to a group of patients to be agreed upon by the Israeli Ministry of Health.
Cell therapies, including immune cell therapies such as DCVax(r)-L, are categorised as 'Advanced Therapy Medicinal Products' in the European Union.
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