New biotech industrial complex to manufacture vaccines for export

Cuba has announced that it will open soon its first high-technology plant in an area of the Mariel Special Development Zone (ZEDM) that is to house a new biotechnological industrial complex. The plant, a joint venture involving the Centre for Genetic Engineering and Biotechnology (CIGB) and BioCubaFarma, will produce vaccines for export including the country’s highly efficacious Abdala anti-COVID. The plant will be known as CIGB-Mariel.

The announcement and comments made during a recent media briefing indicate that for both strategic and economic reasons, Cuba intends significantly developing its biotech manufacturing capacity. It will also encourage external investors to join it in the ZEDM in the production of COVID related vaccines and other advanced bio-pharma products that it has developed for domestic use and export.

Initially CIGB-Mariel will have two formulation and filling lines, one with a capacity for 12,000 units per hour of liquid products in vials, and the other with 3,000. It is intended however that within six months the plant will be able to produce more than 30mn doses annually. Reportedly the plant has the infrastructure and space to expand significantly, and plans exist to build other complexes for new Cuban bio-pharma products if investments are available. The total Cuban investment to date is CUP460mn (US$147mn) which according to a feasibility study must be recovered over 9.9 years. The new complex was designed and executed over four years by a solely Cuban work force. It presently employs 120 people, but around 400 technicians, engineers, and professionals are expected to work in the plant next year.

Speaking to the media, Dr Eduardo Martínez, the President of BioCubaFarma, said that the CIGB-Mariel Biotechnological Industrial Complex forms a part of an investment programme in the national bio-pharma sector. This he said includes investments in the high-tech area in the ZEDM where it is planned to install similar complexes utilising Cuban capital and foreign investment.

Martínez said that BioCubaFarma was promoting a group of projects, some of which had aroused the interest of foreign investors from different countries and with whom the group was in dialogue. “We are sure that we will have other biotechnological and pharmaceutical complexes similar to this one here”, he told journalists.

Noting the potential for export and joint manufacturing ventures with foreign partners, Martínez said, 

“Once we have completed the doses that we need for our country, we are also supplying other nations. We want to dedicate a significant part of the operations of this plant to manufacture the Abdala vaccine. He also told reporters that Cuba was in discussion with the World Health Organisation (WHO) about its intentions. “We have recently informed them that this is going to be the plant to which we are going to transfer the vaccine production technology. It is the plant that we are going to submit to the prequalification of the WHO ”, he told the media.

Speaking about the commissioning, he said that in December the formulation, filling and packaging processes with the antigen will begin. This he said will initially arrive from the facilities of the CIGB, but from the beginning of next year the antigen will also be manufactured in the new complex.

The intention he said is that the complete production of this vaccine will be carried out in the new plant and the hope is “that in 2022 we will be able to have Abdala on the emergency use list and complete the final prequalification of the vaccine by the WHO”.

The President of BioCubaFarma noted that although the plant will be dedicated for a good part of the time to the production of Abdala, it has also been conceived in a manner that would allow for an increase in capacity to produce vaccines in Cuba’s Soberana series, he said, in the light of overseas interest and demand based on their high level of efficacy “where the delta variant predominates”.

Martínez said that the herd immunity effect observed in Cuba and the consequent trend towards a decrease in cases, deaths, and patients in intensive care, had led several countries to indicate their  interest in acquiring the vaccines. “That is why we are interested in achieving significant levels of production at this plant”.

It is expected that the WHO will meet formally this month with Cuba to discuss the inclusion of Cuban anti-COVID vaccines in its emergency list for international use. Speaking about this, the President of BioCubaFarma said that several technical meetings, videoconferences have already been held to provide information and clarify doubts, but this month the official process would begin. This, he said will lead to the delivery of a vaccine dossier which will be evaluated by an international group of experts and the WHO which will carry out on-site visits to the manufacturing facilities. 

“We have experience working with the WHO, as we have several prequalified vaccines. We know the process. We have very good exchange relations with the PAHO-WHO representation in Cuba”, Martínez said, adding that the UN health agency has already appointed the group of experts who will be engaged in the evaluation of Cuban vaccines.

According to the official media platform Cubadebate, other products from Cuba’s CIBG and BioCubaFarma will also be produced at the site. These include HeberFERON (a union of interferon alpha 2b and interferon gamma) used for forms of cancers, Jusvinza a therapeutic vaccine against hepatitis B, and the  CIMAvax-EFG, a vaccine for some forms of lung cancer. These, the online publication reported, will be introduced as finished products with patents and registrations. Other products that may also be developed and finished in the Mariel biotechnological industrial complex are aimed at cardiovascular, cerebrovascular, autoimmune diseases, and cancers.

The Roswell Park Institute of the United States has begun a clinical study of the Cuban CIMAvax-EFG vaccine.

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