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Nick Havercroft – CEO & Founder Bioneb
Biologics are medicines that are made using certain types of cells to produce the right kind of protein. They can also be constituted from many different things in our body, such as RNA/DNA or hormones. These components are then – for the most part – injected into the body because they would be destroyed in our digestive system.
Starting with insulin three decades ago, biologics have become the fastest-growing class of therapeutic compounds. About 300 biologics are now available for human use. These compounds are widely accepted as the most effective means of treating certain diseases, including cancer and rheumatoid arthritis.
Enter biosimilars
About half of the biologics on the market are about to have their patents expire. This presents an opportunity to develop generic versions (biosimilars) and better therapeutic proteins (biobetters) from these 20-year-old agents.
Biosimilars will help reduce the cost of some of the most expensive biologics on the market. But this can only be possible with the early engagement of all parties involved: academics, industry, regulatory agencies and also patient representatives. The latter group’s involvement is a must because the public and clinicians who prescribe such medicines should be satisfied that a biosimilar could replace the expensive brand–name drug. High science from laboratory to better patient care around the world
Biologic medicines are made from living organisms by genetically engineering DNA. DNA is inserted into living cells, such as bacteria, yeast, or cultured animal cells to code for the production of a particular protein.
The biologic is modified to ensure it functions as intended. Specific chemicals are added to control the function of the biologic.
The most effective cell line is selected for expansion. During selection, the cells that can produce the biologic most effectively are identified and expanded to manufacture the medicine. This cell line is unique to each manufacturer and is the source of all future products. The unique cell line is grown in bioreactors and carefully monitored. The biologic drug is then isolated and purified using
sophisticated technology.
Common name drugs, Biologic and Biosimilar Therapeutic Class & Agents which may be used with the technology can Potentially benefit more than half of the world’s population. Humira®, Antibiotics, Insulin, Epinephrine, Imitrex®, Exubera, Anticholinergics, Anti-inflammatories, Hormones, Appetite suppressant, Dopamine agonist, Nicotine, Sildenafil, Sumatriptan, Vaccines, Diazepam, Antiemetics, Stimulants opioids, Suboxone®, Diphenhydramine, Morphine, Corticosteroids, Antiemetics, Buprenorphine and Tadalafil.