*Photo credits: NDS – Nicolich Design Studio
The new Italian industrial complex entirely dedicated to the development and production of cell and gene therapies is called EXELLULA and it will be a world centre of excellence for nonviral technologies. FLYn’ICE, on the other hand, is a project for the transport with drones of Cell and Gene Therapies (CGT) products.
Miami, January 2019 – Ethics, technology, innovation and talent: Anemocyte will be at Phacilitate Leaders World 2019 in Miami from 21 to 25 January, presenting itself as the first BMO, Biotech Manufacturing Organization, active in the field of cell and gene therapies (CGT) with several unique traits such as the identification and use of innovative technological platforms regarding, for instance, nonviral gene modification technologies developed, produced and applied in compliance with the highest quality standards set by rules of good manufacturing practice (GMP) for drugs.
Marco Ferrari, Anemocyte CEO, explains, “In the profound and exponential evolution underway in the Life Science sector, Anemocyte is putting its sound know-how and cutting-edge technologies at the service and support of the development and production of Advanced Therapy Medicinal Products (ATMP), supporting its partners in the complex and delicate effort to translate the best ideas in the sector into reality, creating innovative and effective product and process strategies and solutions for tomorrow’s therapies: from preclinical studies to clinical trials, from development and production to the marketing of a therapy so that patients can benefit from it.”
On the occasion of Phacilitate Leaders World, Anemocyte is telling a new story of Italian excellence in the field of Cell and Gene Therapies (CGT), announcing some important steps in its growth programme:
- The birth of Exellula, the first Italian industrial complex entirely dedicated to the development and production of Advanced Therapy Medicinal Products (ATMP) for third parties, and a world centre of excellence for nonviral technologies;
- The FLYn’ICE project is a strategic partnership aimed at revolutionising the transport of Advanced Therapy Medicinal Products (ATMP)
- Collaboration with Brevetti C.E.A. S.p.A. in the field of the visual inspection of Advanced Therapy Medicinal Products.
Anemocyte has launched an important growth strategy by planning a series of significant investments in production capacity, technology and innovation. This is how the EXELLULA project, the first centre entirely dedicated to the development and production of cell and gene therapies on behalf of third parties, was born. It is an all-Italian investment aimed at creating the most important national manufacturing centre for Cell and Gene Therapies (CGT), one of the most significant private investments in the sector of contract manufacturing of cell and gene therapies currently underway in Europe, with over 2000 square metres of GMP and GMP-compliant facilities for the development and production of Advanced Therapy Medicinal Products (ATMP) and over 500 square metres dedicated to their research and innovation.
The EXELLULA Project provides for the redevelopment, partly completed, of the current Anemocyte headquarters at the Insubrias BioPark in Gerenzano, Varese, and a further expansion which, over the next three years, will lead to the construction in a town near Milan of an innovative centre entirely dedicated to the contract development and production of cell and gene therapies, which in its initial phase of implementation, is expected to triple the company’s current GMP (good manufacturing practice) capacity.
Anemocyte aims to contribute to the evolution of the Cell and Gene Therapies (CGT) sector also in the field of logistics. The innovation proposed by the Italian company at Phacilitate 2019 involves the use of special drones to transport new drugs from the pharmaceutical production sites that, like Anemocyte, are authorised to manufacture them, to clinical centres involved in clinical trial or treatment activities.
The FLYn’ICE, developed by Anemocyte in collaboration with RPS Aerospace S.r.l., a leading Italian company in the design and production of drones, aims to solve important problems such as logging, data traceability, the certainty of delivery times and everything involving the “human factor” associated with traditional logistics.
- Advanced Therapy Medicinal Products often have to be administered to patients within a few hours of production and, equally often, are tailored to individual clinical needs, which are in fact crucial to the patient’s life. A delay in delivery, a loss of such products or even an excessive variation in temperature during their transport can make it impossible to treat the patient for whom they are intended, risking, as a result, to aggravate the patient’s often already precarious health conditions. This new mode of transport also aims to ensure that the raw material from the patient (blood, apheresis or biopsy) for the production of personalised medicinal products arrives at the production site under optimal conditions.
The FLYn’ICE project will use RPS Aerospace RPA Discovery drones, totally autonomous, lightweight, equipped aircraft with a pod, a special cryogenic storage system capable of maintaining and monitoring the temperature of drugs during flight. The pod will also be equipped with an anti-tampering system that will ensure integrity and security, preventing access to the product by unauthorised persons.
The FLYn’ICE, born two years ago from the synergy between Anemocyte and RPS Aerospace, is currently in an advanced testing phase. At present, a campaign of 100 experimental flights is underway, supported by Enac, the Italian Civil Aviation Authority. The first simulation flight, on a real 50 km route, is scheduled by spring 2019
VISUAL INSPECTION OF CELL AND GENE THERAPIES
At Phacilitate Miami 2019, Anemocyte will also present its partnership with the company Brevetti C.E.A. S.p.A., a leading company in the visual inspection of drugs. The collaboration between the two companies has resulted, in fact, in an innovative project for the application of the most advanced visual inspection techniques and technologies to the field of cell and gene therapies. The first results of this joint project will be presented at the upcoming SIG Automation 2019 event scheduled in Milan next May and of which Anemocyte will be a partner.
Anemocyte S.r.l., a company of the Holding F.I.S. Group, is a Biotech Manufacturing Organization (BMO), a biotech company that provides one-stop-shop expertise in the development and production of cell and gene therapies. Anemocyte’s pharmaceutical manufacturing site is located in the Greater Milan Area, in the Insubrias BioPark in Gerenzano, Varese. It is a science and technology park and business incubator in the biotech sector.
Holding F.I.S. S.p.A. is an important Italian group operating in the chemical, pharmaceutical, biotechnology and nanotechnology sectors. The group controls some of the world’s leading manufacturers of active and intermediate ingredients for the pharmaceutical industry (F.I.S. Fabbrica Italiana Sintetici and Delmar), as well as some innovative companies in the pharmaceutical and nutritional (PHF), biotechnology (Anemocyte) and nanotechnology (Brenta) sectors.
Phacilitate believes in the power of partnerships and that through collaboration, anything can be achieved. By fostering the community and bringing together a diverse range of expertise from across the advanced therapies ecosystem, Phacilitate is creating a network of partnerships that brings the industry closer to achieving the ultimate goal of improving patient care and developing commercially viable curative treatments. This is the future of healthcare. Phacilitate unites people through award-winning events, which focus on the business and the science of advanced therapies, creating unforgettable experiences and memories to connect and inspire. Phacilitate Leaders World, Phacilitate Leaders Europe and Phacilitate Leaders Asia are the pillars of the calendar and bring together the entire advanced therapies ecosystem. For more information about Phacilitate, please visit: phacilitate.co.uk.