A biologic is treatment which is derived from a biological method and is mainly composed of sugar, proteins, nucleic acids and maybe of living entities as cells and tissues. Pharmaceuticals on the other hand are chemically synthesized and their structure is known.
Their mode of manufacturing is also different. A biologic is usually manufactured in a living system such as a cell, a micro organism or a living system. Biologics are very complex and large molecules and the technology used to manufacture them is termed as Recombinant DNA Technology. The living systems used to produce biologics can be sensitive to very minor changes in the manufacturing process.
Small process differences can significantly affect the nature of the finished biologic and, most importantly, the way it functions in the body. To ensure that a manufacturing process remains the same over time, biologics manufacturers must tightly control the source and nature of starting materials, and consistently employ hundreds of process controls that assure predictable manufacturing outcomes.
These process controls may also be confidential to the original manufacturer. Therefore, it would be difficult or impossible for a second manufacturer to make the "same" biologic without intimate knowledge of and experience with the innovator's process.
Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.
Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. For Martini, the industry is being shaped by biological products and a greater understanding of medicine. Currently, the industry is moving towards a focused stratified approach, matching the right patient with the right therapy, Martini adds. While dealing predominantly with rare diseases — and possibly orphan diseases in the first instance — he envisages that with more understanding of the technological processes involved with these treatments, more common diseases will also be addressed.
For Kuhlman, the main driver of what is making such advances possible is a greater understanding of individual diseases, including their molecular and genetic constituents of the disease. This has allowed specific targeting of specific genes or pathways within the cells, and has resulted in the development of new technology to deliver controlled genetic manipulation within the cells. Three scientists, whose contributions help world-leading brands and SMEs develop and supply innovative, safe products, share their experiences working in the labs of contract research company Reading Scientific Services Limited RSSL.
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