High-throughput Sequencing (HTS) and Biosimilars

Increasing access to affordable medicines by technological development in industries through South-South knowledge sharing and technology transfer

The project aims primarily to enhance the capacity of the Global South to screen for novel, improved and available drug therapies and share the knowledge among the countries and partners. High-throughput screening (HTS) technologies allow the investigation of the therapeutic effects of biological molecules (either drugs, genes or proteins) that could represent novel biotherapeutics. Screens using genetic and drug libraries are expected to enable South-South collaborations to develop novel biotherapeutics and to repurpose already-approved drugs for new therapeutic uses. 

The objective is to increase the access of the Global South to similar biotherapeutic products (SBPs), commonly known as ‘biosimilars’, as alternatives to more expensive recombinant protein drugs. Recombinant therapeutic proteins are a class of medicinal drugs with high potential to serve as novel therapies. Since several of them are poised to go off-patent, it has become clear that the successful model of generic pharmaceuticals can be effectively transposed to biotherapeutics. This is expected to reduce the costs, meet worldwide demand, promote market competition, and maintain the incentives for innovation.  

The ICGEB collaborates with laboratories in the Global South in the set-up of HTS, opening the way for South-South collaborations in this endeavour. HTS is an experimental drug discovery process that allows to rapidly test a large number of samples for biological activity at the organism, cellular, pathway or molecular level.  In cooperation with the Joint Research Centre (JRC), the ICGEB has been working with scientists in various countries to set up and perform screening programmes to analyse libraries of natural compounds for their potential in the treatment of infectious diseases. These screening processes also aim to identify natural compounds that can interfere with biological processes relevant for non-communicable diseases. The role of the ICGEB is to provide scientific knowledge and technological skills, whereas the JRC’s main function is to identify specific research arenas and local needs that can benefit from the combination of high-throughput workflows with automated high content imaging, with a particular interest in developing in vitro techniques to reduce animal testing. 

The ICGEB focuses on the development of biosimilars, copies of previously authorized biotherapeutic drugs with comparable biological activity, physicochemical characteristics, efficacy and safety. This definition implies that biosimilars do not need to be exact copies of the original biological drugs, but should have almost identical activities. Developers of biosimilars usually do not have access to the protocol used for the production of the original. The ICGEB has been active for several years in facilitating the transfer of technology for the production of several biosimilars to pharmaceutical industries in the Global South. These capacity-building activities have enabled companies to establish the good manufacturing practices (GMP) for clean production of biosimilars. Fifty biosimilars are currently in development and will likely result in a highly competitive marketplace over the next five years. Between 2005 and 2018, 89 technology transfers were successfully conducted in 14 countries of the Global South.  

South-South cooperation is promoted through technology transfer for the production of biosimilars (e.g. China, Bangladesh, Iran).  Biosimilars offer an unprecedented opportunity since they can be produced and marketed by a new class of biotech companies that are small and focused, and thus can rely on relatively limited economic support to achieve competitive success. The ICGEB aims to transfer knowledge of intellectual property protection, regulatory and entrepreneurship skills.  

The project is sustainable since technology transfer and capacity building in these fields are expected to generate novel targets for biological therapies and foster the development of local companies for their commercialization. Scientific advances will generate publications in top journals and thus higher chances to attract additional funds. This will generate revenues that will be re-invested in the project to attract a higher number of countries.  

The project can be replicated in countries interested in developing novel biological products. Others can join and exploit existing platforms to either screen their compounds, set up a screening for their diseases of interests or produce recombinant proteins. Countries that already have the technology in place can receive assistance in setting new screens or improving the different steps of protein production and entry into the market. Finally, countries willing to set up local platforms could benefit from this project as a model to follow during implementation and as hub for future collaborations.