What is a Biopharmaceutical

November 27, 2018, 9:54 294

 

Actually, the primary difference between biopharmaceuticals and traditional pharmaceuticals is the method by which the drugs are produced. Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.

According to Wikipedia biopharmaceutical, also known as a biologic(al) medical product, biological, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semi-synthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial.

Terminology regarding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. Within EMA contexts, the term advanced therapies refer specifically to ATMPs, although that term is rather nonspecific outside those contexts.

 

Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

In some jurisdictions, biologics are regulated via different pathways than other small molecule drugs and medical devices.

The first such substance approved for therapeutic use was biosynthetic "human" insulin made via recombinant DNA. Sometimes referred to as rHI, under the trade name Humulin, was developed by Genentech, but licensed to Eli Lilly and Company, who manufactured and marketed it starting in 1982.


Major classes

 

Extracted from living systems

Some of the oldest forms of biologics are extracted from the bodies of animals, and other humans especially. Important biologics include:

  • Whole blood and other blood components

  • Organs and tissue transplants

  • Stem cell therapy

  • Antibodies for passive immunization (e.g., to treat a virus infection)

  • Human breast milk

  • Fecal microbiota

  • Human reproductive cells

Some biologics that were previously extracted from animals, such as insulin, are now more commonly produced by recombinant DNA.

 

Produced by recombinant DNA

As indicated the term "biologics" can be used to refer to a wide range of biological products in medicine. However, in most cases, the term "biologics" is used more restrictively for a class of therapeutics (either approved or in development) that are produced by means of biological processes involving recombinant DNA technology. These medications are usually one of three types:

  1. Substances that are (nearly) identical to the body's own key signalling proteins. Examples are the blood-production stimulating protein erythropoetin, or the growth-stimulating hormone named (simply) "growth hormone" or biosynthetic human insulin and its analogues.

  2. Monoclonal antibodies. These are similar to the antibodies that the human immune system uses to fight off bacteria and viruses, but they are "custom-designed" (using hybridoma technology or other methods) and can therefore be made specifically to counteract or block any given substance in the body, or to target any specific cell type.

  3. Receptor constructs (fusion proteins), usually based on a naturally occurring receptor linked to the immunoglobulin frame. In this case, the receptor provides the construct with detailed specificity, whereas the immunoglobulin-structure imparts stability and other useful features in terms of pharmacology.

 

Major kinds of biopharmaceuticals include:

  • Blood factors (Factor VIII and Factor IX)

  • Thrombolytic agents (tissue plasminogen activator)

  • Hormones (insulin, glucagon, growth hormone, gonadotrophins)

  • Haematopoietic growth factors (Erythropoietin, colony stimulating factors)

  • Interferons (Interferons-α, -β, -γ)

  • Interleukin-based products (Interleukin-2)

  • Vaccines (Hepatitis B surface antigen)

  • Monoclonal antibodies (Various)

  • Additional products (tumour necrosis factor, therapeutic enzymes)

 

Biologics have had a profound impact on many medical fields, primarily rheumatology and oncology, but also cardiology, dermatology, gastroenterology, neurology, and others. In most of these areas, biologics have added major therapeutic options for the treatment of many diseases, including some for which no effective therapies were available, and others where previously existing therapies were clearly inadequate. However, the advent of biologic therapeutics has also raised complex regulatory issues, and significant pharmacoeconomic concerns, because the cost for biologic therapies has been dramatically higher than for conventional (pharmacological) medications.

Older patients who receive biologic therapy for diseases such as rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis are at increased risk for life-threatening infection, adverse cardiovascular events, and malignancy.

The first such substance approved for therapeutic use was biosynthetic "human" insulin made via recombinant DNA. Sometimes referred to as rHI, under the trade name Humulin, was developed by Genentech, but licensed to Eli Lilly and Company, who manufactured and marketed it starting in 1982.

 

 

                                                                                                                                                                                                                                                  By  Aliyev F. 

 

References

  1. https://en.wikipedia.org/wiki/Biopharmaceutical

  2. https://www.morganmckinley.ie/article/difference-between-pharmaceutical-and-biotechnology

  3. https://www.sciencedaily.com/terms/biopharmaceutical.htm