ATMPSAEGIS Training Master Planning System
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Holoclar (Chiesi Farmaceutici SpA) is a marketing-approved advanced therapy medicinal product (ATMP) containing autologous limbal stem cells.
Their decision confirms that our new Geleen facility is indeed viewed by industry experts as meeting the requirements and client expectations for late clinical stage and commercial manufacturing for ATMPs. We look forward to support ImmunoCellular in their effort to develop ICT-107 for the benefit of European patients."
London, United Kingdom, June 22, 2018 --( SMi is delighted to have interviewed, speaker, Ioannis Papantoniou, ATMP Bioprocessing Coordinator, Skeletal Biology and Engineering Research Centre, KU Leuven regarding his thoughts and experiences within the cell & gene therapy space.
In this presentation, Chiesi will take a deeper look into the logistics and restricted access program constraints in bringing ATMPs to patients in a commercial setting.
Release date- 22082019 - EUCOPE and DIA are delighted to invite you to their 1st Joint Workshop on ATMPs, Innovative Gene and Cell Therapies in the EU, taking place in Basel, Switzerland on the 29 and 30 October.
Its consultants bring over 100 years of combined experience specific to the cell and gene therapy industry, having deep CMC experience, focused on Advanced Therapeutic Medicinal Products (ATMPs) and their regulation by the FDA, the EMA and other jurisdictions.
Cell and gene therapies make up the advanced therapeutic medicinal products (ATMPs) market.
Generium has more than 30 innovative products in the pipeline, including enzymes, monoclonal antibodies and ATMPs. Generium is headquartered in Moscow, Russia.
The JV will implement Orgenesis' point-of-care, or POCare, cell therapy strategy with a goal to bring advanced therapy medicinal products, or ATMPs, to patients at the therapeutic setting by leveraging Orgenesis' and TheraCell's combined technical, regulatory and commercial expertise in Greece, Cyprus, Balkan region and Turkey.
It is a leading European contract development and manufacturing organization (CDMO) for advanced therapy medicinal products (ATMPs) with state-of-the-art facilities in Munich that are fully compliant with all current EU ATMP regulations, BSL2 and ICH guidelines.
Irving is also co-authoring a White Paper for appropriate microbiological controls for ATMPs manufacturing.