Natalia Elizalde PhD, Chief Business Development Officer, VIVEbiotech.
VIVEbiotech is a GMP Contract Development and Manufacturing Organisation (CDMO) fully specialised in lentiviral vectors working according to both EMA´s and FDA´s regulations operating since 2015 for more than 40 international clients in Europe, US, Asia and Australia.
Specifically, the company is specialised in the manufacture of lentiviral vectors that are being used for the development of both gene-modified cell therapy products -ex-vivo administration- as well as for gene therapy products -in-vivo administration-.
VIVEbiotech has a well-established manufacturing platform that is employed from developmental phases to GMP production. More than 100 batches in reactors have been manufactured in a scalable, timely, and cost-effective manner, adhering to EMA and FDA GMP regulatory standards and adapting to the specific scale required for each phase.
There are two main reasons why the company fully specialised on lentiviral vectors: the growing market demands, from one side, and the high technical expertise that is required to manufacture this kind of viral vectors, from the other.
Referring to the market growing demands, it is important to highlight that the cell & gene therapy (CGT) area is forecasted to be the fastest growing segment within the pharmaceutical market. Indeed, the current market value stands tall at $758 Bn in 2020, with the potential for a significant growth beyond $1.200 Bn in 2026. The CAGR for the CGT market is expected to be around 50% by 2026 while that of the overall pharmaceutical sector is predicted to be around 8%.
There is indeed a scarcity of players with the capacity to offer end-to-end manufacturing services. This is why CDMOs like VIVEbiotech, which bridge the gap between R&D and commercialisation, are experiencing an increasing demand. Moreover, a significant number of pharmaceutical and biotechnology companies currently do not possess the capability to internally manufacture CGT. This is the driving factor behind the projected growth of outsourced lentiviral vector supply, expected to achieve a Compound Annual Growth Rate (CAGR) of 15% from 2020 to 2026.
This expected growth can be easily justified linked to the fact that more and more CGT approvals are happening in the last years – there have been more approvals in the last 3 years than in the prior 15 years- among which lentiviral vectors have been the gene transfer technology used in 8 of these marketed therapies.
The CGT pipeline is getting stronger with 2,061 ongoing clinical trials globally at 1H´22, with immuno-oncology the most common therapeutic area under study. Specifically, lentiviruses are the main vector used for immuno-oncology applications as they are very efficient in gene delivery, they guarantee long-lasting transfer gene expression, they have improved safety features and present low immunogenicity.
As reflected in the latest H1 2023 ARM report, immuno-oncology remains at the forefront among all ongoing clinical trials (+50%) of which the majority consist of T-cell and NK cell therapies (+90%). This is somewhat expected considering that there is an increase in the number of people being diagnosed with cancer and is expected to grow by a further 50% compared to 2020, exceeding 28 million people.
Moreover, CGTs are progressively expanding beyond rare diseases. Increasingly more frequent or prevalent diseases are being treated with lentiviral vectors which are being used for manufacturing vaccines or viral like particles, among others. Indeed, currently lentiviral vectors are being used in 48% of total clinical trials, which is more than double the usage for AAVs.
All of this information taken together makes it clear that lentiviral vector manufacturing capacity is a pivotal factor in the development of these therapies. Therefore, the scarcity of experienced CDMOs with established virology expertise is the primary reason why it can be asserted that viral vector manufacturing constitutes a critical bottleneck for the industry, affecting both cost and the high-quality provision of vectors at a suitable scale for every phase.
Speaking of the significant technical expertise involved, the manufacture of lentiviral vectors is a highly intricate process that demands skilled personnel possessing knowledge in both virology and GMP regulations for the production of sterile products. Viral vectors are highly sensitive; therefore, limiting their exposure to harsh environments is necessary to minimise product loss.
Lentiviral vectors are sensitive to factors such as pH, temperature, shear, and chemical composition (salt), necessitating controlled conditions during both processing and storage.
Ensuring that the process is regulatory compliant, scalable, and cost-effective from the very early stages, and executing it in a timely manner, is indeed crucial for the successful manufacture of a given therapy at a commercial scale. Thus, VIVEbiotech has specialised Technological Innovation, Upstream and Downstream Optimisation departments whose objective is adapting to the very specific requirements of our partners to make sure that the vector that is being produced is scalable and cost-effective, and high titers and pure vectors are obtained from the very beginning. Moreover, some of the ongoing innovative projects that VIVEbiotech is working on include various pseudotypes, modified cells, and/or stable cell lines, among others.
Moreover, in the global landscape of the lentiviral vector space, there exists a very limited number of fully specialised players. VIVEbiotech is the sole GMP CDMO fully specialised in lentiviral vectors in Europe.
Taken together, these factors clearly demonstrate an interest in CDMOs leveraging their unique expertise to bridge the gap between R&D up to commercialisation. In this regard, VIVEbiotech stands out by adapting to the real needs of the market in a rational and sustainable growth mode, aligned with current demands offering specialised services in lentiviral vectors, covering the entire spectrum from the initial phases to GMP-compliant commercial scale.