ReiThera, a contract development and manufacturing organisation based in Italy, has expanded its viral production operations facility located in Castel Romano Technopole, Italy, to meet the demand for viral vectors globally.
The expansion included the construction of a specialised production area which opened in May 2020. It was developed with an investment of €15m ($14.6m) and was authorised for good manufacturing practices (GMP) production in June 2022.
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The Italian Medicines Agency (AIFA) has granted operating authorisation to ReiThera to begin large-scale viral vector production for vaccines and gene therapy at the new production area.
The expanded facility will serve ReiThera’s customers, including major pharmaceutical and biotechnology companies. ReiThera specialises in viral vector production and has developed a range of production processes that can be applied to vaccines and advanced therapies.
Location
ReiThera’s production facility is located in Castel Romano Technopole in Rome, a major industry area that is host to a number of labs and companies dedicated to biotechnology, research and development and experimental research.
ReiThera viral vector production facility details
The expansion of ReiThera’s viral vector production facility is based on a 1,000m² (10,763ft² ) site that includes a bulk production area, filling capacity, warehouse, cold storage and an area dedicated to future expansion.
The facility is equipped with the latest generation of stirred tank bioreactors with capacities of 200L, 1,000L and 2,000L to support GMP-compliant manufacture of therapies based on adeno-associated virus (AAV) and adenovirus (Ad), from 50L to up to 3,000L (combined 2,000L and 1,000L).
ReiThera’s existing production facility details
The existing production facility spans 8,500m² (91,493ft²) and includes production areas, a quality control laboratory and process and technology development areas.
The production facilities include six GMP suites including four drug substance (DS) suites and two drug production (DP) suites. The GMP areas include three Class C spaces for Adeno, AAV and lentivirus, and one Class B area for MVA and HSV. ReiThera can provide customised production scale from 2L to 200L and up to 2,000L.
In addition, ReiThera can offer a dedicated area to produce personalised cancer vaccines. Each GMP area is supported by independent HVAC systems, rendering a GMP area configuration capable of supporting concomitant GMP activities without cross-contamination.
The facility also features 350m² (3,767ft²) of space for in-house GMP expansion and 8,500m² (91,493ft²) for future site expansion.
Equipment installed and technology details
ReiThera offers proprietary platforms for third-party productions, including exclusive packaging cell lines comprising HEK293, DF1 and Duck cell, and a Gorilla Ad (GRAd) vector platform. It also produces GMP batches of multiple adenovirus serotypes, including AAV, MVA and HSV-1, using different cell lines.
ReiThera’s novel proprietary replication-defective Gorilla adenoviral vector, the GRAd vector, belongs to species C adenoviruses, which are considered among the most potent vaccine carriers for the induction of T cell responses to the encoded antigens and have low seroprevalence in humans. GRAd vector technology has been validated in human clinical trials and can be offered for licensing for immune-oncology and anti-infective treatments.
The upstream cell culture and infection steps for bulk drug substance (BDS) manufacturing rely on state-of-the-art suites, which include bioreactors available in various sizes up to 2,000L.
Downstream processing uses chromatography and TFF systems, and is scaled to meet the large production volume.
The facility has an on-site manual and semi-automated filling line for 3,500 vials, extendable to 10,000 vials. The filling line can also be configured for small volumes and batches.
Product details
ReiThera offers flexible GMP scaling for clinical and commercial materials, including stirred-tank bioreactors for class production in suspension, as well as fixed-bed bioreactors for cell growth in adherence. It also produces GMP AAV, Ad, MVA, and HSV, with expertise in developing scalable viral-vector manufacturing processes.
