How Anemocyte is Changing History as a Biotech Manufacturing Organization (BMO)
Headquartered in Milano, Italy, Anemocyte is the world’s first company to identify as a Biotech Manufacturing Organization (BMO). The company’s Cell Therapy Platform supports the manufacturing of autologous and allogeneic products, its DNA Platform produces plasmid DNA for viral vector production, and its Gene Therapy Platform supports process development and implementation for non-viral gene modified cells.
Home to a 500 sq. m. GMP facility designed for the production for Advanced Therapies under cGMP conditions, Anemocyte also has a state-of-the-art Plasmid Manufacturing Unit and 300 sq. m. of lab space for technological implementation, tech transfer and process development.
I recently had the honor of interviewing Anemocyte’s CEO, Marco Ferrari. In this interview, we explore the company’s role as a Biotech Manufactoring Organization, its ongoing investment into research and technology, and the company’s future directions.
Interview with Anemocyte’s CEO, Marco Ferrari
Cade Hildreth: When was Anemocyte founded and what is its area of specialization?
Marco Ferrari: Anemocyte is a Biotech Manufacturing Organisation (BMO), a lead innovator in the field of Advanced Therapies Medicinal Products. Anemocyte can count on more than 15 years of experience in the field of Cell & Gene Therapies (CGTs) and more than 60 years in the contract manufacturing business being part of the Nine Trees Group.
Thanks to its strong scientific, technical and regulatory expertise, today Anemocyte sets itself to be the core of Cell and Gene Therapy evolution. Its main areas of focus are those dedicated to plasmids and somatic cells development and manufacturing as well as to non-viral gene modification approaches.
Regarding the latter, Anemocyte believes that non-viral cell modification will gain more and more popularity in the next years juxtaposing with the already well-established cell engineering by viral vectors. Anemocyte is presently developing a platform for non-viral cell modification.
To this purpose, the company made an agreement with Maxcyte becoming a Center of Excellence for its technology. Maxcyte developed a cGMP compliant electroporator for non-viral delivery of nucleic acids and Anemocyte can use it for internal platform development and offer such a technology to Clients.
Cade Hildreth: This is a fascinating background. I understand that Anemocyte identifies as a Biotech Manufacturing Organization (BMO). What does this term mean and how does it differentiate Anemocyte from other CMOs?
Marco Ferrari: A BMO is a “peculiar beast” whose DNA is a combination of a Biotech and a CMO DNA. As a result, a BMO is capable of bringing in the right competencies and technologies at the right time and addressing the pain points of the industry by anticipating the client’s needs, providing solutions, and thinking like an innovative biotech company. Immediately understanding customer’s needs, and even anticipating them, is something absolutely invaluable in the CGTs industry. Proactivity and curiosity are key features of a BMO, as well as flexibility.
As a BMO, Anemocyte gives special attention to innovation and talents. Thanks to such approach the company is today able to anticipate industry trends (e.g. non-viral solutions), provide capacity and competences to respond to current needs of the industry (e.g. plasmid development and manufacturing) and open new paths of innovation in the field (Anemocyte’s open innovation Project, e.g. FLYn’ICE).
Cade Hildreth: Thank you for that explanation. What is the importance of having the company located in Italy, which is a major market for the production of gene therapies?
Marco Ferrari: Being located in Italy today is truly an opportunity. During the last 20 years the Italian Cell and Gene Therapy Community has been able to create an unparalleled ecosystem made of excellent researchers and Research Centers, leading Clinicians and Hospitals, ambitious start-ups and competent regulatory authorities.
It is not hard to imagine as such a lively and competent ecosystem might facilitate exposure to innovation and knowledge, nurture talents and competences and favor investments. Anemocyte today can surely leverage on the above to consolidate and even accelerate its contribution to the growth of CGTs industry.
Cade Hildreth: Anemocyte recently announced the launch of an Italian industry complex dedicated to the development and production of cell and gene therapies, named EXELLULA. Could you please tell me about EXELLULA and why was it created?
Marco Ferrari: EXELLULA has been conceived as a very flexible and dynamic initiative, able to adapt very quickly to the need and complexity of CGTs industry and capable to bring in competences, innovation and capacity for the industry “at the right time”. Perfect example of such approach is Anemocyte new plasmid unit, which represents the first step of the EXELLULA initiative.
It represents a state-of-the-art solution for a real need of the industry to solve the bottleneck in the production/supply of plasmid for viral vector.
Through EXELLULA Anemocyte is actively contributing to the evolution of the CGTs sector creating a point of reference in the cell and gene therapy space. With EXELLULA Anemocyte is addressing the global needs of the industry and is gathering in Italy – one of the liveliest market for the production of cell and gene therapies – competencies, ideas and technologies capable of leveraging cell and gene therapies worldwide.
Cade Hildreth: What types of facilities are being built out to support this national manufacturing center (EXELLULA)?
Marco Ferrari: Anemocyte today can rely on two manufacturing clean room facilities, designed to address Cell and Gene therapy needs: one is focused on somatic cells and non-viral modified cells, the other fully dedicated to plasmid manufacturing. Additional capacity is planned to be built during next years to continuously support the growth of the CGTs industry and offer the right quality and volume at the right time.
Cade Hildreth: Anemocyte also announced the recent launch of FLYn’ICE, a project for the transport of Cell and Gene Therapy (CGT) products via drones. What is the importance of FLYn’ICE and how will it revolutionize the CGT industry?
Marco Ferrari: As a BMO, we look at the potential needs in the industry. One of these needs is certainly related to logistics, an important element in the chain of value of Cell and Gene Therapies. The FLYn’ICE project was born as a collaboration between two Italian excellences, Anemocyte and RPS, and aims to solve important problems in the CGTs logistics, such as for example data traceability (ensuring a thorough control of the cold chain), the certainty of delivery times and everything involving the “human factor” associated with traditional logistics (chain of control, custody, etc.).
The initiative will lead to the implementation of a validated platform of logistics by mean of autonomous drones. Projects as FLYn’ICE are helping to position Anemocyte as a BMO and confirm the originality of such new approach in bringing value to the CGT industry.
Cade Hildreth: Anemocyte is known for its ongoing investment into research and technology development. What are some of the investments that you’ve recently made into these areas?
Marco Ferrari: Anemocyte continues its effort to identify and develop manufacturing strategies aiming to “sustainability” and “manufacturability”. As example of that, we recently started collaboration in the area of culture media, to evaluate serum free GMP compliance solutions. Additionally, Anemocyte continues exploring automation to address all steps of manufacturing and analytical of the cell and gene therapy product journey.
Cade Hildreth: Do plasmids represent a potential market for Anemocyte, and if so, what supply and demand trends do you see in this area?
Marco Ferrari: Anemocyte is proactively investing in the plasmid market to provide the right quality at the right time (Anemocyte new Plasmid Manufacturing Unit allows production of R&D, High Quality and GMP plasmids addressing all applications: from discovery research through commercial production). Plasmids are building blocks for both viral and non-viral based gene modification. The increasing number of cell and gene therapy products, moving along the different clinical phase up to commercial, results in an increasing demand of plasmids with a quality standard GMP compliant.
Cade Hildreth: What are your 5 year goals for Anemocyte?
Marco Ferrari: Anemocyte is surely aiming to consolidate its leadership in the CGT industry, establishing itself as a point of reference for Cell & Gene manufacturing worldwide. To do so the company is continuously investing to strengthen its position as innovative manufacturer of plasmids and provider of non-viral solution while leveraging on its peculiar BMO status.
Moreover, Anemocyte is renewing its active contribution to innovation in the CGT space through the development of tangible new solutions to speed up the growth of the industry and solve major pain points still affecting the manufacturing, the logistics and the sustainability of such products.
Cade Hildreth: How can people get in touch with you or learn more about Anemocyte, EXELLULA, or FLYn’ICE?
Marco Ferrari: Your readers can get in touch with us at the links below and we would be happy to hear from them.