November 01, 2006
Technobyte, The News, Karachi

Revolution, cigars and now vaccines

By Asadullah


Legendary Che Guevara and Fidel Castro would definitely be remembered for the socialist revolution in Cuba but the ailing octogenarian Castro must be credited with another revolution that places the country amongst the top in the field of biotechnological sciences. And the significance of all such development in a developing country is benefiting the developing world the most. The Center for Genetic Engineering and Biotechnology (CIBG) had made its presence in Pakistan with its products through a pharmaceutical company. Its director of regulations and clinical trials, Dr Pedro Lopez Saura has been visiting Pakistan to check the clinical trials that his centre together with its pharmaceutical partners is running. The CIBG's most popular product in the developing world including Pakistan is its vaccine against hepatitis-B called Heberbiovac, says Dr Pedro Lopez Saura in an exclusive interview to The News...



They sent the strongest medical contingent, which rendered longest hours of service to the quake-hit Pakistan; then established official ties by opening up their mission in Islamabad; but their scientists had established links with Pakistan almost eight years ago with their genetically-developed vaccines.

From the words 'revolution and cigars' comes only one name in mind: Cuba. But its avant-garde Center for Genetic Engineering and Biotechnology (CIGB) has added another feather to the socialist Caribbean entity with its leaping success in biopharmaceuticals particularly genetically-engineered vaccines and interferon against hepatitis.

Legendary Che Guevara and Fidel Castro would definitely be remembered for the socialist revolution in Cuba but the ailing octogenarian Castro must be credited with another revolution that places the country amongst the top in the field of biotechnological sciences. Now, Cuba produces and exports the world's most effective hepatitis B vaccine to more than 30 countries.

Cuban biotechnologists have also developed the world's first synthetic vaccines for the prevention of pneumonia and meningitis, raising the profile of Western Havana's bio-cluster, which also includes CIGB and several institutes, to a new level of recognition worldwide for vaccines, interferon, pharmaceuticals, diagnostics and plant, animal and industrial biotechnology.



And the significance of all such development in a developing country is benefiting the developing world the most. The CIBG had made its presence in Pakistan with its products through a pharmaceutical company. Its director of regulations and clinical trials, Dr Pedro Lopez Saura, has visited Pakistan several times in connection with different clinical trials and training.

This time visiting Pakistan two-weeks prior to his 59th birthday, Dr Pedro Lopez says the CIBG's products that include hepatitis-B and meningitis-B vaccines, interferon, the first synthetic flu vaccine, have been marketed in the developing world. "The products developed in CIGB laboratories are registered in 61 countries and exported to 32 developing countries," he adds.

Dr Pedro has been visiting Pakistan also to check the clinical trials that his centre together with its pharmaceutical partners is running. The CIBG's most popular product in the developing world including Pakistan is its vaccine against hepatitis-B called Heberbiovac. "We have done several clinical trials and its efficacy and safety have been demonstrated here."

"In Pakistan, we are also in the process of registering another vaccine against haemophilus influenzae, which is one of the main causes of meningitis and pneumonia and other infections in small children," he said. "They're in the process of registration. We have not done clinical trials for it here but certainly we have done trials back home."

And how is it like bringing in Cuban drugs to Pakistan? "When we come here we have to bring a heavy dossier of our products so that Pakistani authorities can review our achievements," he adds. "Sometime national authority requires trials in its home country and that happens quite often because of a possible varying efficacy of a certain drug to different ethnic population."

How far is the idea of attenuated and genetically manipulated vaccine? "When you apply modern genetic engineering and biotechnology, you can choose the part of the virus or bacteria that is needed for protection against it," he answers. "Putting it into another host like yeast or any non-dangerous bacteria and then you can produce the molecules and make the vaccines, without handling the dangerous virus or bacteria."

And this is called recombinant vaccines because this is done by genetic manipulation of the bacterial genes. This is exactly what scientists at the CIBG have done with their hepatitis-B vaccine. Instead of working with hepatitis-B virus, they only use what is called the surface antigen, which is one part of the virus not responsible for the disease.

"Produce this surface antigen in yeast and isolate it. When you inject this antigen to a person he'll be protected against the virus," Dr Pedro very candidly shares the open secret of what the CIBG has been dealing with for the last 20 years of existence. It has introduced and developed all modern molecular and biological methodologies, in strict adherence with Good Manufacturing Practices, validated and reviewed by the authorities and even the WHO.

At present we have introduced in our national health system 18 products including diagnostic products such as screening kits for AIDS and hepatitis. "At the 20 years of our existence, we can proudly claim that there is not a single Cuban family, which has not benefited from one of our products," said the unassuming Cuban scientist. "And I can say there are many Pakistani families to endorse our claims as well."

Though CIBG has so far made no professional or academic collaboration with any of Pakistani institutions, but Dr Pedro believes it will take sometime. He also sees the increased cooperation between the two poles-apart nations as founding stone of a lasting friendship. "The relationships between our countries have been straightened after medical brigade and even Cuban embassy has opened up in Islamabad earlier this year."

"Several circumstances that have brought our countries closers, one of them is the services of Cuban medical brigade and the efforts we are putting in with our products," he maintained. "Our countries have come closer with more opportunities of collaboration. I have read some Pakistani students going to study medicine in Cuba. I am sure our links will be strengthened in the near future."

The CIBG's products are already in India, Iran, Vietnam, China, Malaysia, Thailand and Pakistan. And its managers are in the process of registration in Indonesia, Philippines and Sri Lanka. "Our products in terms of quality are same or even better, as is the case of hepatitis-B vaccines, from the ones available from the so-called the first world. We strictly maintain quality," Dr Pedro claims accentuating the fact that all is validated by the WHO.

"Our centre is an example that things can be done in developing world. We have many PhDs even at our centre but many come from University of Havana. Many of them have had postgraduate education abroad mainly in Europe but that's less necessary now. We're now more experienced. Part of my own PhD was done in Belgium and Germany before the final presentation made in Havana."

There is virtually no sale to developed Western countries, but the CIBG scientists believed that it could change in the years to come if a line of drugs that control cancer come on line. The experimental drugs target epidermal growth factor, a protein associated with the growth and spread of tumors in a range of cancers, including lung, breast and colon cancer.

Cuba's state-run Western Havana biotechnology cluster encompasses around 50 research and development centers organised under the Council of State, led by President Fidel Castro. Scientists are optimist that spiraling revenue will make the pharmaceuticals sector the island's fifth-largest foreign exchange earner, after tourism, remittances, the export of professional services and nickel.

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