Protein Biologics is one of the most promising discoveries in the biomedical field ever. Recombinant protein biologics have revolutionized healthcare globally. Insulin, blood clotting factors, vaccines, monoclonal antibodies, and dozens of other protein biologics are used to fight life-threatening ailments like anemia, Von Willebrand’s disorder, diabetes, cancer, hepatitis, Rabies, multiple sclerosis, etc. Recombinant protein vaccines have drastically improved the development cycle and safety of vaccines. Immunotherapies using engineered antibodies are the most promising cancer treatments at the moment.
Dependence on cold chains limits the accessibility of life-saving protein biologics in developing nations and significantly increases the cost of transportation and storage. Most developing countries do not have an integrated cold-chain. India needs an infusion of USD100 Billion in the cold chain sector. The cold-chain failure cost USD 35Bn to the pharma industry. Around 10 percent of this is due to the increased cost of logistics; the rest of the cost comes from the loss of material, repetition of clinical studies, etc.
Insulin is a prime example of cold-chain dependence; that greatly limits the availability of the drug in Asia and African markets. Around 450 million people are affected by diabetes worldwide. Recombinant Insulin is central to diabetes management, for both type1 and 2 diabetes patients. WHO reported that due to the lack of life-saving drugs like Insulin, patients from lower-income groups in Asia and Africa are prime sufferers of diabetes-associated complications like Kidney failure, amputations, and even death
Even 100 years after Insulin discovery, multiple barriers prevent access to it. In 2016, diabetes caused 1.6 Mi deaths worldwide. The majority of causalities were in lower and middle-income countries, including India, mainly due to the limited accessibility and high cost of life-saving Insulin.
The traditional formulation of Biotherapeutics exhibit short life in-vivo with lower concentration and is also cold chain dependent. At Lamark we offer Insugen Strong , our patented human insulin which has 5 times higher in-vivo stability, 20X higher concentration and also the first ever thermostable molecule with a shelf life of around 2 years at room temperature