Cuban experts today concluded the transfer of monoclonal antibody technology to Vietnam through Genfarma, the joint venture established by both countries in August of last year.

During a ceremony held at the Hoa Lac High-Tech Park, located about 30 kilometers from downtown Hanoi, regulatory authorities awarded the facility the Good Manufacturing Practices (GMP) certification in the presence of Cuban Ambassador Rogelio Polanco.

The plaque was received by Genfarma Chief Executive Officer Bui Le Khoa from Ta Manh Hung, deputy director of the Drug Administration Department of the Ministry of Health, who urged company executives and staff to maintain the national and international quality standards achieved.

Manh Hung noted that this marks the first time Vietnam has obtained monoclonal antibody technology, opening new opportunities for the production of advanced medicines for the Vietnamese people.

In this regard, he recommended completing the administrative documentation required to ensure the development of high-quality, safe, and stable products.

Genfarma Plant Manager Manuel Enrique Montané highlighted the project’s milestones, including the implementation of the quality management system, the qualification and calibration of more than 120 pieces of equipment, and the completion of approximately 5,000 laboratory analyses.

“Through the quality management system, we documented around 1,000 calibrations and more than 1,300 documents as evidence of our compliance with good manufacturing practices,” Montané stated.

Regarding production, he reported that the facility has produced 44,000 vials, including three batches of the monoclonal antibody Cimaher, the first one manufactured in Vietnam.

Cimaher is the name used in Vietnam for nimotuzumab, a monoclonal antibody used in the treatment of head and neck cancer that has been tested in approximately 70 countries.

When discussing the team’s strengths, the Cuban scientist highlighted that 80 percent of the 74 employees are university graduates.

As part of the implemented quality system, approximately 350 documented training sessions have already been completed, covering good manufacturing practices, product knowledge, industrial safety, and specific workplace training.

Both Montané and other speakers emphasized that what was achieved on Tuesday represents the completion of the first stage of the project. In terms of future plans, the Genfarma plant manager announced that the company aims to expand by nearly 20,000 square meters through its own efforts and cooperation with national and international partners.

Future developments include the construction of an active pharmaceutical ingredient plant, the expansion of filling lines with new technologies, and facilities for the production of blood-derived products.

The company also plans to expand laboratory capabilities with a biological activity unit, which, Montané explained, will allow the facility to guarantee a closed production cycle.

Genfarma Deputy General Director Norkis Arteaga stated that the achievement is the result of long-standing cooperation between Cuba and Vietnam, combining Cuba’s scientific knowledge and technological expertise with Vietnam’s capabilities in investment, organization, production, and marketing.

“The purpose is to produce medicines made in Vietnam using biotechnology technologies,” she said.

Meanwhile, Research Director Miladis Limonta explained that the next step will be the production of new medicines at Genfarma, with the company open to the best experiences in biotechnology and the development of new technologies.

Le Thanh Son, deputy head of the management board of Hanoi’s high-tech zones and industrial parks, said the result is the outcome of effective international cooperation between Vietnam and Cuba.

He added that it is also clear evidence of Vietnam’s ability to receive, assimilate, master, and develop cutting-edge technology.

During the event, a video message was shown in which BioCubaFarma President Mayda Mauri congratulated the Genfarma team on obtaining the Good Manufacturing Practices certification and described the company as part of the strategic cooperation between Cuba and Vietnam.