The Essence Of Biopharmaceutical Management Lies In The Manufacturing Process

calendar 24 September 2022

Biopharmaceutical technology is changing treatment procedures in a significant manner. Doctors can now treat patients with diabetes, cancer, or other diseases with custom treatments due to the action on selected cells. A significant improvement from the pharmaceuticals is the specificity of treatment we can achieve in biopharmaceuticals, and consequently, we observe lesser side effects. An example of such medication is Heparin, which acts at various points to anticoagulated blood, but biopharmaceutical medicines can act on specific sites.

Manufacturing biopharmaceuticals is significantly challenging due to technological challenges. While an aspirin consists of 21 atoms of carbon, hydrogen and oxygen, a biopharmaceutical drug may contain from 2,000 to 25,000 atoms. The production of biopharmaceuticals is challenging and costly as they may take from four to five years for manufacturing and expensive raw materials are required. Since, the biopharmaceutical industries are producing products which are quite effective in the market, a constant assessment of the operations, techniques and strategies used in the production of the drugs. The manufacturing process of biopharmaceuticals comprises two main processes:

  • Upstream processing: entails the development of culture-based proteins from bacterial or mammalian cells. Bacterial cells go through microbial fermentation in which microorganisms help break down large organic substances. An example of microbial fermentation is the breakdown of sugar by yeast. Mammalian cells, which are acquired from mammals, are grown in vitro using an artificial growth medium like amino acids.
  • Downstream processing: entails the skills required to separate and purify the product from the culture mixture which was developed by biosynthesis. Biosynthesis is a process through which we obtain complex products from substrates using enzymes. It also includes the treatment, recycling and disposal of the waste obtained from the products.

Important Properties Of Biopharmaceutical Medicines

We often fall sick due to the interaction of microorganisms with the human body. After contracting a disease, it is imperative to maintain the basic functions in the body to minimise the long-term damages and sometimes, prevent death. Pharmaceuticals are used to prevent, diagnose and treat diseases. Additionally, they may be used to restore bodily functions after experiencing degradation from a disease. While pharmaceuticals are plant-based and chemically synthesised, biopharmaceuticals are produced using living organisms or their cells through the use of engineering fields (such as biotechnology) and molecular biology. An example of a biopharmaceutical drug is insulin which has been used to control diabetes successfully. The primary contrast from plant-based or chemically synthesised drugs is that biopharmaceuticals target specific cells and molecules and consequently, reduce the possibility of side effects. Another example is the development of vaccines for prevention and protection from diseases such as SARS-CoV-2, tetanus and polio.

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Different Categories Of Biopharmaceuticals

Many pharmaceutical companies are turning into biopharmaceutical companies, and they are focussing on developing drugs for long-term diseases such as medications for cardiovascular diseases and diabetes. Biopharmaceuticals are used in the treatment of several diseases such as diabetes and Covid-19, and they are classified into several categories. The different kinds of biopharmaceuticals are mentioned as follows.

  • Cytokines - are molecules used in cell signalling and communication. It can aid with inter-cell communication during immune responses and stimulate the movement of cells to help with inflammation or infection.
  • Enzymes - are complex proteins which catalyse changes in other substances without changing themselves. For example, lactase helps in the digestion of milk proteins.
  • Peptide therapeutics - are chains of amino acids. Naturally occurring peptides can be used as hormones or neurotransmitters. Neuroscientific Biopharmaceuticals, an Australian public company, focusses on the development of peptide-based products and aims to provide treatment for various neurodegenerative disorders like Alzheimer's.
  • Vaccines - are microorganisms which can stimulate an immune response in the body against disease or some kind of resistance. Example: Covid-19 vaccines.
  • Monoclonal antibodies - are constructed from immortal cells with antibody-producing spleen cells. They are used in the treatment of diseases such as breast cancer and leukaemia.
  • Cell therapies - It is a process in which new cells are inserted into tissues for treatment. An example is the bone marrow stem cells used for the treatment of leukaemia and other blood disorders.
  • Antisense drugs - these drugs contain parts of messenger RNA, and are used to hamper the growth of disease-causing proteins. Antisense oligonucleotides are used in the treatment of cancer.
  • Hormones - are chemicals that carry information and messages amongst cells. The process in which they affect the human body is slower than enzymes. An example is insulins which help in controlling diabetes.

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Latest Research Areas In Biopharmaceuticals

Monoclonal Antibodies (MABs) are clones or replications of antibodies extracted from a human body which were used to fight a certain disease or infection in the body. An example of the use of MABs is to fight cytokine storms. For some people, the immune system may affect the body in a counterproductive way. During Covid-19 or any such serious infections, the immune system might release cytokines in excessive amounts which if not controlled, can cost a person even their life. This can be treated and cytokines suppressed by a kind of monoclonal antibody. MABs have also helped fight the Covid-19 virus. MABs are manufactured in majorly three categories: (1) created from mouse proteins, (2) created from a combination of mice and humans, and (3) created solely from human proteins. Students pursuing research in biopharmaceuticals can avail biology assignment help services.

Another extraordinary treatment process is gene therapy. Through human gene therapy, we change the genetic expression to treat the ailment. The molecules found in the gene may be defective and hinder the functioning of a gene. This defect in the gene will translate to the functioning of the cell and hence treatment of the specific areas where defects are observed within the expression of a gene is required. Human gene therapy allows us to correct, replace, or remove the smallest parts of the DNA. It can be done in four ways: (1) replacement of a gene which is causing the disease, (2) removal of a section of the DNA which is hindering the functioning of the gene, (3) deactivation of an improperly functioning gene, and (4) activation of a gene which can help fight the disease.

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