Immunization, said the parties, remains one of the most impactful and cost-effective public health interventions in LMICs, which are still struggling to secure access to adequate supplies.
The collaborative effort between ReiThera, an Italy-based biotech focused on the development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies, and Exothera, a Belgian full-service contract development and manufacturing organization (CDMO) has won a €3m (US$3.2m) grant by the Bill & Melinda Gates Foundation.
The award is for the development and delivering of new low-cost vaccines based on ReiThera’s GRAd technology platform, against COVID-19 and HIV, mostly for LMICs in Africa.
The partners are looking to develop a scale-up manufacturing process for the production of ReiThera’s vaccine candidates based on its GRAd platform, including its COVID-19 vaccine candidate (GRAd-COV2).
The scale-up development will leverage an upstream platform developed by Exothera’s sister company, Univercells Technologies, which was designed for automated large-scale virus manufacturing in a compact footprint.
Under the terms of the agreement, Exothera will scale up the proprietary cell line, infection with the GRAd vector follows to create the bulk vaccine product, which ReiThera will then purify. The viral bulk generated after the infection will be purified by a high performing process developed by ReiThera.
Potent vaccine carrier
ReiThera’s GRAd-COV2 is a candidate vaccine against SARS-CoV-2 based on the novel and proprietary replication-defective Gorilla adenoviral vector encoding the full-length coronavirus spike protein.
The GRAd vector belongs to species C adenovirus that are considered the most potent vaccine carriers and has low seroprevalence in humans, said the Rome headquartered firm.
Recent Phase 1 and 2 studies, it reported, have demonstrated that GRAd-COV2 is safe and well-tolerated in adults and elderly, as well as in subjects with comorbidities, with seroconversion rates over 93% after a single dose and over 99% with a two-dose regimen. “These results support further clinical development of the candidate vaccine with a Phase 3 study.”
Last month saw Exothera, which began operations in 2020, achieve GMP certification for its facilities in Jumet, Belgium.
The company said that accreditation from Belgium’s Federal Agency for Medicines and Health Products (FAMHP), which followed a series of inspections, would enable it to extend its services to more customers, supporting biopharma companies from the early development of biotherapeutic candidate to full scale manufacture.
The Jumet site, it added, is now one of Europe's largest state-of-the-art facilities with a GMP qualified manufacturing area totaling 2,100 m² (22,600 ft²). The facility includes five upstream grade C cleanrooms with several bioreactor technologies for adherent and suspension cell culture. The bioreactors can go up to 2 x 2,000L for the suspension platform and 2 x 600m² (2 x 6,450 ft²) for the adherence platform.
To date, the Belgian CDMO has worked on more than 28 projects for clients in the EU and US and reports that it has the space available to develop a further 9,000 m² (96,900 ft²) on the Jumet campus plus other greenfield options, with it also weighing up options to grow internationally “depending on client needs”.
The addition of more manufacturing capacity is an important step to alleviate some of the current constraints in the industry. The pressure to develop and manufacture billions of vaccines, together with an expected 30+ new drug approvals by the US Food and Drug Administration (FDA) in the next year will put immense pressure on the global manufacturing capacity, it stressed.