ReiThera Srl is a biotech company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies, from early development to final QP release. The company boasts many achievements – just recently, they have produced and delivered the first ChAd3 Ebola Sudan vaccine doses to help the WHO outbreak response in Uganda, before both Merck and Oxford University/Jenner Institute.
The company’s management and scientific teams have long and rich experience in the biotechnology arena. Mr Stefano Colloca, the company CTO and one of its co-founders, explains that the team has been working together for almost 20 years. Within Okairos, a company which itself spun out of Merck, they successfully developed genetic vaccines against major infectious diseases, including hepatitis B and C, malaria, HIV, Respiratory Syncytial Virus and Ebola, using the highly innovative chimpanzee-derived Adenovirus (ChAd) platform.
After the acquisition of the brand by GlaxoSmithKline (GSK) in 2014, Okairos changed its name to ReiThera and worked with GSK to further develop the technology and promote clinical development of viral-vectored vaccines against infectious diseases.
“As GSK’s strategy changed, so did our core business and the company transformed from providing only R&D for novel vaccines to including manufacturing activity for third parties. We have produced over 80 GMP lots over the last 4 years,” says Mr Colloca.
Capitalizing on its successful experience from early preclinical development to clinical studies and GMP manufacturing, ReiThera is now offering robust high-quality services while developing innovative advanced therapies based on different viral vector technologies.
Scientific Expertise; Avant-Garde Facilities
“We are working with a large number of companies, including consolidated pharmaceutical businesses to biotech start-ups and academic institutions, helping them to develop their projects and realize their vision. We provide a number of services, starting from the development of scalable and industrial processes that can be then transferred into the manufacturing area to produce GMP lots from Phase I to III. This is our core business, this is where we thrive,” Mr Colloca explains.
To accommodate increasing demand, in 2020 the company initiated the construction of a new 1500 m2 production facility – worth over 15 million euros – dedicated to the large-scale production of viral vectors for vaccines and gene therapy. This investment permitted the installation of the latest-generation stirred-tank bioreactors with scaled volume capacities of 200, 1,000 and 2,000 litres.
The facility has just received operational authorisation from the Italian Medicines Agency (AIFA), a major milestone for the company that is set to pave the way for further business expansion.
Designed to meet the growing global demand for viral vector production, the new facility offers maximum flexibility in processing scale, able to accommodate GMP production based on Adenovirus (Ad), Adeno-associated virus (AAV) and Lentivirus starting from 50 litres up to a maximum of 3,000 litres.
Sound Business Model
Mr Colloca reflects that manufacturing for third parties is widely considered a less risky business model in today’s complex financial environment, when gaining access to funds for research and development is increasingly difficult. “We specialise in viral vectors, which is quite a complex production process, and the fact that we can scale this process up from 2 to 2,000 litres is a great advantage in delivering our clients’ goals.”
He explains that the GMP facility was originally designed for a different level of production, starting from personalised vaccines produced at the 2-litre scale for single patients subject to cancer immunotherapy to the 200-litre scale for the medium-scale process for Phase I-II of clinical trials. The new, expanded facility is designed perfectly for larger scale and commercial production and authorized, at the moment, for production and release of phase III API.
“We can now guide our clients from process development, via scalable industrial processes, up to the commercial phase and then potentially licence to commercial scale production,” he points out.
Specialist in Its Field
This comprehensive service is one of their differentiators but not the only one – ReiThera boasts a specialisation that not everyone can offer. “We have the experience of a vaccine developer and we also have experience in both technology development and improvement,” says Mr Colloca.
The Immunology team has strong laboratory expertise in the analysis of both humoral and cellular immunity directed at the encoded antigens and the viral vector itself. They have expertise in the design and sponsoring of GLP toxicology and biodistribution studies of viral vector-based vaccine candidates with the instrumental success of programme progression through to clinical testing.
ReiThera has also developed tools and procedures based on high-throughput sequencing for the generation of human monoclonal antibodies for virtually any native antigen involved in human diseases, for both therapeutic and diagnostic applications.
Its Technology Development is set to unlock the potential of the viral-vector gene delivery platforms for any medical need. The team is deeply skilled in creating new and innovative cloning strategies for a number of viral vector systems, including Adenoviruses, Adeno-Associated Viruses (AAV), Modified Vaccinia Ankara (MVA), Rhabdoviruses, Lentiviruses and Retroviruses.
Quality, Trust, and Consistency
Mr Colloca acknowledges that the company can be proud of its many achievements reached over the years. “We are working on small viruses like AAV and Adenovirus vector that can be terminally sterilised by filtration, but we are also working on large viruses like HSV or MVA that cannot be filtered. So, the entire process must be aseptic. We have developed and validated aseptic processes for both viruses and this is pretty uncommon in the CDMO world.”
“The main objective for a client coming to a CDMO is to obtain good quality. This constitutes a key focus – not just to deliver the vaccine or gene therapy, but also to maintain a high level of quality with lot-to-lot consistency. This is crucial. We have an excellent track record from this point of view – our success rate is close to 100%. The other thing our clients’ value is a friendly environment, and that we can provide. We work closely with our clients from the beginning, building a relationship based on trust.”
With the expanded, fully equipped new facility, the future seems exciting for ReiThera. “We plan to fill up the approved space and then invest in further expansion. Our target is to reach €100 million in revenue within five years. A challenging target but we have the space and the capacity to get there,” concludes Mr Colloca.
To learn more, email: businessdevelopment@reithera.com
