In a meeting between researchers and technologists at Plant 14 of CIGB, where Jusvinza is produced, strategies to increase the productive capacity and availability of this drug were analyzed: an immunoregulatory therapeutic product, which has been used for treatment of hyperinflammation in COVID-19 patients, and in clinical trials to treat autoimmune diseases, such as rheumatoid arthritis.
The manager of this product at CIGB, Dr. Gillian Martínez Donato, commented:
Jusvinza is composed of the synthetic peptide CIGB 814, derived from the cell stress protein 60, designed with bioinformatics tools. It is the first Cuban therapeutic product based on synthetic peptide technology, which makes it an innovative drug, while in our pharmaceutical industry there is no experience of a product that has been registered, whose active principle is a synthetic peptide. Jusvinza has treated nearly 4,000 patients during the pandemic in Cuba.
For the production of Jusvinza, raw materials are needed, such as amino acids and organic solvents with a specific quality, which are only supplied by large pharmaceutical monopolies in developed countries, and for Cuba they are very expensive.
He then added that the CIGB Petid Production Plant “was inaugurated on July 31, 2020, with the aim of scaling the production of peptides, which make up several innovative therapeutic candidates of the CIGB, which are in the stage of clinical development, for the treatment of cancer, cardiovascular and cerebrovascular diseases, among others “.
For its part, the processes of visual review, labeling, packaging and packaging of the Jusvinza product are carried out in the Plant 10 unit of the CIGB Production area, which has maintained a high production standard, and for more than 10 years consecutive years it has received the Certificate of Good Manufacturing Practices, issued by the Cuban regulatory authority, Center for the Control of Medicines, Equipment and Medical Devices (Cecmed).
The process of synthesis and productive scaling of the Jusvinza peptide has had great challenges, which especially young people have assumed, with the guidance of more experienced researchers. Together they have designed and developed strategies to the productive escalation of this molecule, and that the drug was available to our public health system, in the control of the current COVID-19 pandemic.
When referring to the personnel in charge of the production of this medicine, the Product Manager pointed out that:
“ Young people have been the main protagonists. Committed to the Cuban Revolution and its people, they have sought alternatives in the face of difficulties, without losing one minute and complying with good manufacturing practices required by regulatory agencies. “
“In a very short time, these young people have overcome many challenges: first, due to the need for the compassionate use of Jusvinza in patients with COVID-19 in a serious or critical clinical condition; then, given the widespread use of this product and its inclusion in the Cuban action protocol against COVID-19; and now, they have had to accelerate production to face the new wave of positive cases of this disease.”
It has been a continuous process, which they have had to escalate and face numerous difficulties, which the young people themselves have been able to solve professionally, maintaining the production standards described for this type of product, without stopping the production process . To obtain the Emergency Use Authorization from Jusvinza, this stage of the process was very important, “he added.
Continuing to increase the productive capacities of Jusvinza continues to be the vigilance of this group of young people, who do not escape the difficulties for the timely acquisition of reagents and solvents that are supplied by large pharmaceutical monopolies in developed countries.
The Cuban biopharmaceutical industry has the support, initiatives, willingness and dedication of young people and all the personnel working in this productive stage.
When referring to the commissioning of the Peptide Production Plant, MSc. Ever Pérez Hernández, Head of the also known as Plant 14, expressed:
“For us it was a challenge, considering that it is the first plant in Cuba that produces synthetic molecules of peptide origin. We started with small scales, and today we have already scaled four times, which allows us to respond to the demand of Jusvinza. We have been increasing production capacities and young people have played an important role in this task. “
“If today we have this production established, in less than a year, with two inspections by the Cuban regulatory agency, Cecmed, it is due to the imprint they have put on it Young”.
He then added: “I would also like to highlight the activity of the Engineering colleagues that has been decisive in the installation of all the auxiliary systems, the compressors, the water coolers to guarantee the climate of the areas. it has been everyone’s job “.
“Every quarter we exceed the amount of product that we deliver to the national health system. To date, we have generated a significant number of doses; but for next quarter and for next year we intend to increase these production levels”.
“We certainly want more. The objectives for the coming periods are to continue increasing production levels, maintaining excellence in the manufacture of the Jusvinza product“, , concluded the interviewee.
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