This Wednesday (16), Instituto Butantan and the pharmaceutical company Sandoz do Brasil signed with the Ministry of Health for the sale of 398,000 units of the drug adalimumab, to be distributed to seven states through the Brazilian Unified Health System (SUS). The first delivery, consisting of 177,000 syringes, will be made by December; the remaining units will be delivered by May 2023. Adalimumab is a state-of-the-art drug recommended for the treatment of chronic inflammatory autoimmune diseases such as rheumatoid arthritis, spondyloarthritis and psoriasis, as well as diseases of the gastrointestinal tract such as Crohn’s and colitis.
This delivery is the result of a Productive Development Partnership (PDP) agreement signed at the end of 2021 between the institutions. The technology transfer from Sandoz to Butantan will allow the production of adalimumab to be carried out entirely in the national territory, in the institute’s own factory, accelerating the logistics of distribution in public health establishments. Around 30,000 people may benefit from the drug every year.
“The main advantages of this agreement are the guarantee of supply, which prevents against the risk of interrupting the treatment of patients with chronic diseases; price stability, since it is predefined; acquisition of technologies and development of technical skills, and creation of jobs,” explains Butantan’s Business Director, Hubert Guarino.
Butantan will be responsible for planning and managing operations. The technology transfer will take up to 10 years, starting with training in the production of the Active Pharmaceutical Ingredient (API) for four years, and moving on to the formulation and filling stage – which, together with the API stability study and the registration of the product by the Brazilian Health Regulatory Agency (ANVISA), should last for another five years.
Monoclonal antibodies
Adalimumab is composed of monoclonal antibodies, recognized worldwide as one of the frontiers of biotechnology for the treatment of diseases. The technology consists in multiplying antibodies with specific targets (called antigens) in a laboratory. Antibodies are proteins produced by the immune system to identify and eliminate invading agents, such as viruses, bacteria and tumor cells. Because it is a targeted treatment, it involves far fewer adverse effects than conventional therapies.
Butantan has other agreements under negotiation for the production of monoclonal antibodies intended for other diseases, such as leukemia, breast cancer and respiratory diseases. “The prospect is that Butantan becomes one of the main producers of monoclonal antibodies in Brazil in the coming years,” says Hubert.
Advanced and sustainable structure
The drug will be produced at Butantan’s monoclonal antibody factory, completed in 2020 after an investment of BRL 160 million. With state-of-the-art equipment in an area of more than 5,000 square meters, the plant will be able to produce high-cost medicines for cancer and autoimmune diseases.
The facility has bioreactors made with disposable single-use bags – instead of stainless steel –, where cells are cultivated and monoclonal antibodies are produced. This allows the production of several types of antibodies in the same factory, without the need for decontamination and cleaning operations, in addition to contributing to water savings. This innovative technology also allowed the structure to be built quickly, in just 18 months.
