Inosan Biopharma at the IST 2019

The world in which Inosan Biopharma was created presented a challenge: many pharmaceutical companies, choosing to focus on more profitable product lines, were in the process of, or had completely abandoned, the business of antivenoms. Infamously difficult to produce, especially at scale, antivenoms were increasingly becoming a neglected industry.

Yet the global need for antivenoms was growing, not shrinking, and people were increasingly vulnerable, across the world, to injury and death from animal envenomation. This was placing a burden on families, organizations and governments in the affected regions. People of modest means, whose livelihood required them to work close to the danger, and with limited access to quality healthcare, were hit the hardest.

Inosan Biopharma was founded with a simple but powerful idea: in the technologically advanced world we live in, no one should suffer or die because of animal envenoming. To fulfill this mission, Inosan Biopharma committed itself to produce and make available a new generation of polyvalent biotech antivenoms with high efficacy, safety and stability. These antivenoms would need to be available in all countries and regions where they were needed, and would require us to collaborate on programs securing proper usage and effective “last mile” delivery of them.

As stated in Nature: Although great progress has been made over the last few decades in the manufacturing of antivenoms, these efforts have not always been recognized and highlighted. We can state today that antivenom production has left the field of “artisan biologicals”, de facto entering the sphere of BIOTECH.

We are part of this evolution, through our innovations in the field. Since we took on the challenge of addressing the worldwide need for antivenoms, we consistently worked on improving our production process from beginning to end. We believe our antivenoms reflect the latest and best of what the current understanding of biochemistry and immunology allows. Inosan has developed a new state of the art process for the production of a new generation of polyvalent antivenoms that consist of lyophilized, very pure antigen-binding immunoglobulin fragments (equine F(ab’)2 fragments) of high neutralizing potency that are very well-tolerated by the majority of patients.

Reproducibility and consistent quality from batch to batch of a biological product is another challenge we had to overcome to fulfill our mission. Our dedication paid off, and we currently have achieved consistent quality and a Good Manufacturing Process, certified by multiple regulatory agencies including the Mexican COFEPRIS, a member of PICS. This certification is recognized by the FDA and the EMA.

A final, but most critical stage in order to have a successful antivenom was to make it stable at region IV temperatures. We achieved this through important advances in lyophilization. Because of them, our product is quick to dissolve and it is so stable, it can retain its effectiveness for up to 6 months, stored at 40 degrees Celsius. As you know, conditions such as these are common in the regions where snake bite or scorpion sting accidents occur.

We take inspiration from WHO guidelines when designing our antivenoms and their deployment programs. As a result, regional coverage of our antivenoms has gotten very close to WHO guidelines. We expect to reach 100% coverage in the near future. We have worked diligently, as recommended by WHO, to register our products with local authorities. All of this has made things easier for the medical personnel who deal with animal envenoming in the field. By listening to the people who work with our product, we better adapt to the different needs of each country and culture.

Our efforts in development, production and distribution, would be fruitless if our product became unaffordable. Antivenom manufacturing is quite complex and expensive, which is what originally led to the abandonment of the segment by many pharmaceutical companies. Our high specificity technology has allowed us to manufacture larger batches with a fraction of the venom needed by competitors’ processes, and our horses’ yield is 10 times the industry standard. Having reached a manufacturing capacity of almost 2 million vials a year, our product is the most cost-effective in the market.

For all the work we have done in this field, important challenges remain. The greatest one is access. High yields allow for the production of greater volume at a lower cost, but even though we are able to manufacture large quantities, we are still working on getting the product to the people who need it.

Education is also needed with respect to the cost benefits of our product. Due to their high potency, our antivenoms require less doses to achieve better results than our competitors’ products. In many cases our product might seem more expensive, but once you consider all the doses required, it is much more affordable than other brands.

We are highly motivated because we know there is great need for what we make. We go to the places where the envenoming happens, we talk to the patients, the medical personnel, the experts and the authorities. We know there is a lot of work to do.

We see ourselves as part of the solution and have great hopes for our work with organizations such as the WHO, regional and national authorities, and experts and academics such as yourselves. Today, no one should suffer or die from the consequence of animal envenomation.

To learn more, please watch the video below:

https://www.youtube.com/watch?v=Z3SRJF4-q6g

— Inosan Biopharma

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