About Bio-Logics

About Biologics and Biosimilars

An introduction into Bio Technology, the interaction between biology and human technology. A recent revolution in biotechnology has resulted in a new class of medicine, the Biologics, and which has subsequently been further developed into  Biosimilars.

An introduction to Bio Technology

  • The term describes interaction between biology and human technology
  • The breakthrough for modern biotechnology came when DNA was discovered in the 50’s with the first medicinal drugs coming from natural sources such as herbs, plants,roots, vines and fungi
  • Traditionally chemical drugs were developed and referred to small molecules. Well known medicines such as acetylsalicylic acid were used to treat a wide range of illnesses.
  • A recent revolution in biotechnology has resulted in a new class of medicine, the Biologics, and which has subsequently been further developed into  Biosimilars.

What are Biologics and Biosimilars

  • A biologic medicine is a large molecule typically derived from living cells that are used in the treatment, diagnosis or prevention of diseases.
  • These include therapeutic proteins, DNA, vaccines, monoclonal antibodies and fusion proteins,
  • Biologics and biosimilars are far more comlex structurally, than the small molecule laboratory drugs and are often 200 to 1000 times as large
  • They are highly sensitive to their manufacturing and handling conditions making them more difficult to produce than small molecule drugs.
  • Due to their size and sensitivity, Biologics are almost always injected into the body and individual patient responses can depend on how a Biologic is made
  • The most efficient method of administration is through the pulmonary tract and Micron Micro Mesh technology now makes this possible.
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How are Biologics and Biosimilars medicines developed?

Biologics and Biosimilars are made in living organisms to produce proteins to treat various diseases by genetically modifying cell constructs or cell lines.DNA technology is used to insert desirable genes or remove undesirable ones within a living cell or via a vector such as a virus.This prompts a specific function such as the production of a protein to treat diseases.
Biotechnology has led to the development of many of todays most important medicines including monoclonal antibodies for the treatment of cancer and human insulin for the treatment of diabetes. The genetic code of a chosen protein (Insulin) is identified and replicated but combining different segments of DNA to build a functional DNA sequence. The DNA sequence is introduced into the host cell of a living organism such as bacteria, yeasts or mammal cells altering the genetic makeup and coding to produce the chosen protein.
Genetically modified cell lines are carefully selected and cultured in large bioreactors. The bio-logic or bio -similar medicine is extracted through complex purification processes. Each step is intricate, sensitive and specific to a particular medicine. Minor alterations may lead to changes in cell behavior, structure,stability or other quality aspects of the end product. Any of these differences have the potential to affect the treatments safety, efficiency or shelf life which will increase the risk of an unwanted immune response.
About Bio-Logics
The patents of a growing number of biologic medicines are due to expire over the next few years, which has led to an increased interest in development of biosimilars. Biosimilars are more affordable therapeutic options, but, given the complexity and cost of development and manufacturing, are not expected to generate the same level of cost savings as generics. We intend to utilise years of biologics experience and manufacturing expertise that will assist in developing high quality, consistently and reliably supplied biosimilars in order to benefit patients in need of therapeutic alternatives.

Examples of Bio-Logic &Bio-Similars medicines made with DNA.

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