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Ignatius Doronin
Ignatius Doronin

Pharmaceutical Biotechnology by Vyas and Dixit: An Essential Book for Biotechnological Topics and Applications


Pharmaceutical Biotechnology by Vyas and Dixit: A Comprehensive Review




Pharmaceutical biotechnology is a branch of science that applies the principles and techniques of biotechnology to the development, production, analysis, and delivery of drugs. It encompasses a wide range of topics such as immobilization, recombinant DNA technology, monoclonal antibodies, protein and peptide delivery, gene delivery, molecular principles of drug targeting, and new generation vaccines. Pharmaceutical biotechnology has revolutionized the field of medicine by providing novel solutions for diagnosis, prevention, treatment, and cure of various diseases.




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One of the most comprehensive books on pharmaceutical biotechnology is "Pharmaceutical Biotechnology" by S. P. Vyas and V. Dixit. The authors are eminent professors at Dr. Hari Singh Gour University in India with extensive experience in teaching, research, consultancy, administration, publication, patenting, editing, reviewing, organizing conferences/workshops/seminars/symposia etc. in various fields related to pharmaceutical sciences. The book covers all important biotechnological topics of academic and industrial interests with quality concepts and potential problems in research in biotechnology and newer drug delivery systems. The book is divided into eight chapters that cover basic topics for both undergraduates and postgraduates. In this article, we will review the main topics covered in the book and how they are relevant to current research and applications.


Immobilization




Immobilization is a process of attaching or confining a biological entity such as an enzyme, a cell, or an organelle to an inert support or matrix. Immobilization has several advantages such as increased stability, reusability, ease of separation, enhanced activity, reduced inhibition, improved specificity, and reduced cost. However, immobilization also has some disadvantages such as loss of activity, diffusion limitations, mass transfer resistance, leakage, and contamination.


There are various methods of immobilization such as adsorption, covalent binding, cross-linking, entrapment, encapsulation, and affinity binding. Each method has its own merits and demerits depending on the type of biological entity, the support material, the reaction conditions, and the desired application. Immobilization methods can be classified into two categories: physical and chemical. Physical methods involve non-covalent interactions between the biological entity and the support such as electrostatic forces, hydrophobic forces, hydrogen bonds, van der Waals forces etc. Chemical methods involve covalent bonds between the biological entity and the support such as amide bonds, ester bonds, disulfide bonds etc.


Immobilization has various applications in biotechnology such as pharmaceutical production, biocatalysis, biosensors, bioseparation, bioremediation etc. Some examples of immobilized enzymes are glucose oxidase for glucose biosensors, penicillin acylase for penicillin production, lipase for biodiesel production etc. Some examples of immobilized cells are yeast cells for ethanol production, bacterial cells for insulin production, plant cells for secondary metabolite production etc. Some examples of immobilized organelles are chloroplasts for photosynthesis studies, mitochondria for energy metabolism studies etc.


Recombinant DNA technology




Recombinant DNA technology is a technique that involves the manipulation of DNA molecules from different sources to create new combinations of genes or genetic material. Recombinant DNA technology has four basic steps: isolation of DNA from source organisms, cutting of DNA into fragments using restriction enzymes, joining of DNA fragments using ligase enzymes, and introduction of recombinant DNA into host cells using transformation or transfection methods.


Recombinant DNA technology has various applications in biotechnology and medicine such as gene cloning, gene expression, gene therapy, genetic engineering, transgenic animals and plants, DNA fingerprinting, DNA sequencing, polymerase chain reaction (PCR) etc. Some examples of recombinant DNA products are human insulin for diabetes treatment, human growth hormone for growth disorders, erythropoietin for anemia treatment, interferons for viral infections and cancers, vaccines for infectious diseases etc.


Monoclonal antibodies




Monoclonal antibodies are antibodies that are produced by a single clone of B cells that recognize a specific antigen. Monoclonal antibodies have high specificity and affinity for their target antigen and can be produced in large quantities and purified easily. Monoclonal antibodies are produced by fusing B cells from an immunized animal with myeloma cells (a type of cancer cell) to form hybridomas that secrete monoclonal antibodies. Monoclonal antibodies can be further modified by genetic engineering or chemical conjugation to improve their properties.


Monoclonal antibodies have several advantages over polyclonal antibodies such as uniformity, reproducibility, low cross-reactivity, low contamination, and easy characterization. However, monoclonal antibodies also have some disadvantages such as immunogenicity, cost, limited diversity, and ethical issues. Monoclonal antibodies have various applications in biotechnology and medicine such as immunotherapy, immunodiagnostics, and drug delivery. Some examples of monoclonal antibodies are rituximab for lymphoma treatment, trastuzumab for breast cancer treatment, adalimumab for rheumatoid arthritis treatment, pregnancy test kits for detecting human chorionic gonadotropin (hCG), enzyme-linked immunosorbent assay (ELISA) for detecting antigens or antibodies etc.


Protein and peptide delivery




Protein and peptide delivery is a process of delivering therapeutic proteins and peptides to the target site in the body. Protein and peptide delivery faces many challenges such as degradation by proteases, denaturation by pH or temperature changes, low permeability across biological membranes, low bioavailability due to rapid clearance or metabolism, and immunogenicity or toxicity due to foreignness or aggregation. Protein and peptide delivery strategies aim to overcome these challenges by enhancing the stability, bioavailability, Protein and peptide delivery




Protein and peptide delivery is a process of delivering therapeutic proteins and peptides to the target site in the body. Protein and peptide delivery faces many challenges such as degradation by proteases, denaturation by pH or temperature changes, low permeability across biological membranes, low bioavailability due to rapid clearance or metabolism, and immunogenicity or toxicity due to foreignness or aggregation. Protein and peptide delivery strategies aim to overcome these challenges by enhancing the stability, bioavailability, and pharmacokinetics of proteins and peptides.


There are various factors that affect the stability, bioavailability, and pharmacokinetics of proteins and peptides such as molecular weight, charge, hydrophobicity, conformation, solubility, aggregation, degradation, absorption, distribution, metabolism, and excretion. Protein and peptide delivery systems aim to optimize these factors by modifying the structure or formulation of proteins and peptides or by using carriers or devices that can protect, target, or release proteins and peptides at the desired site and time.


There are various types of protein and peptide delivery systems such as nanoparticles, liposomes, micelles, polymers, hydrogels, microspheres, implants, patches etc. Each type has its own advantages and disadvantages depending on the route of administration, the target site, the release profile, the biocompatibility etc. Protein and peptide delivery systems can be administered by various routes such as oral, nasal, pulmonary, transdermal, ocular, and parenteral. Each route has its own challenges and opportunities depending on the anatomy, physiology, and pathology of the site. Some examples of protein and peptide delivery systems are insulin nanoparticles for oral delivery, glucagon-like peptide-1 (GLP-1) micelles for nasal delivery, parathyroid hormone (PTH) liposomes for pulmonary delivery, erythropoietin (EPO) patches for transdermal delivery, interleukin-1 receptor antagonist (IL-1Ra) hydrogels for ocular delivery, and interferon-beta (IFN-beta) implants for parenteral delivery.


Gene delivery




Gene delivery is a process of delivering exogenous genetic material to the target cells in the body. Gene delivery has two main goals: gene therapy and gene vaccination. Gene therapy aims to correct or compensate for defective or missing genes that cause diseases. Gene vaccination aims to induce immune responses against pathogens or tumors by delivering genes that encode antigens or immunomodulators.


Gene delivery faces many challenges such as low transfection efficiency, low expression level, low stability, low specificity, low safety, and low immunogenicity. Gene delivery vectors are vehicles that can carry and deliver genes to the target cells. Gene delivery vectors can be classified into two types: viral and non-viral. Viral vectors are derived from viruses that have been modified to remove their pathogenicity and to insert foreign genes. Non-viral vectors are synthetic or natural materials that can bind or encapsulate genes and facilitate their entry into cells.


Viral vectors have several advantages over non-viral vectors such as high transfection efficiency, high expression level, high stability, and high immunogenicity. However, viral vectors also have several disadvantages such as limited capacity, potential toxicity, potential immunogenicity, potential insertional mutagenesis, and ethical issues. Viral vectors can be further classified into four types: retroviral vectors, adenoviral vectors, adeno-associated viral vectors, and lentiviral vectors. Each type has its own merits and demerits depending on the type of gene, the type of cell, the type of disease etc.


Non-viral vectors have several advantages over viral vectors such as large capacity, low toxicity, low immunogenicity, low insertional mutagenesis, and low ethical issues. However, non-viral vectors also have several disadvantages such as low transfection efficiency, low expression level, low stability, and low specificity. Non-viral vectors can be further classified into two types: physical methods and chemical methods. Physical methods involve physical forces or devices that can deliver genes to cells such as electroporation, microinjection, gene gun etc. Chemical methods involve chemical compounds or complexes that can deliver genes to cells such as lipids, polymers, peptides etc.


Gene delivery




Gene delivery has various applications in biotechnology and medicine such as gene therapy, gene vaccination, genetic engineering, transgenic animals and plants, DNA fingerprinting, DNA sequencing, polymerase chain reaction (PCR) etc. Some examples of gene delivery applications are cystic fibrosis gene therapy using adenoviral vectors, HIV gene therapy using lentiviral vectors, cancer gene therapy using retroviral vectors, hepatitis B gene vaccination using plasmid DNA, golden rice genetic engineering using agrobacterium-mediated transformation, glow-in-the-dark fish transgenic animals using microinjection, paternity testing DNA fingerprinting using PCR etc.


Molecular principles of drug targeting




Drug targeting is a process of delivering drugs to the specific site of action in the body. Drug targeting has several benefits such as enhanced efficacy, reduced toxicity, reduced dosage, and improved compliance. However, drug targeting also has some limitations such as complexity, cost, variability, and unpredictability. Drug targeting involves molecular mechanisms that determine the interaction between drugs and targets. Drug-target interactions depend on various factors such as affinity, specificity, selectivity, potency, efficacy, and safety.


Affinity is the strength of binding between a drug and a target. Affinity is influenced by the molecular structure and properties of both the drug and the target such as shape, size, charge, polarity, hydrophobicity etc. Specificity is the degree of binding between a drug and a target relative to other targets. Specificity is influenced by the molecular diversity and similarity of both the drug and the target such as functional groups, binding sites, receptors etc. Selectivity is the degree of binding between a drug and a target relative to other tissues or organs. Selectivity is influenced by the molecular distribution and accessibility of both the drug and the target such as blood flow, permeability, transporters etc.


Potency is the amount of drug required to produce a certain effect. Potency is influenced by the molecular activity and responsiveness of both the drug and the target such as concentration, kinetics, dynamics etc. Efficacy is the extent of effect produced by a drug. Efficacy is influenced by the molecular outcome and feedback of both the drug and the target such as signal transduction, gene expression, cellular function etc. Safety is the absence of adverse effects caused by a drug. Safety is influenced by the molecular toxicity and tolerance of both the drug and the target such as metabolism, excretion, immunogenicity etc.


Drug targeting strategies aim to enhance the affinity, specificity, selectivity, potency, efficacy, and safety of drugs by modifying the structure or formulation of drugs or by using carriers or devices that can protect, target, or release drugs at the desired site and time. Drug targeting strategies can be classified into two categories: passive targeting and active targeting. Passive targeting relies on the natural properties and behaviors of drugs and targets such as size exclusion, enhanced permeability and retention (EPR) effect etc. Active targeting relies on the artificial modification or addition of drugs and targets such as ligand-receptor binding, antibody-antigen binding etc.


Some examples of drug targeting strategies are liposomal doxorubicin for passive targeting of solid tumors, antibody-drug conjugates for active targeting of cancer cells, nanoparticles for passive targeting of inflamed tissues, aptamers for active targeting of thrombin etc.


New generation vaccines




New generation vaccines are vaccines that use novel technologies and approaches to induce immune responses against pathogens or tumors. New generation vaccines differ from conventional vaccines in terms of antigen source, antigen presentation, adjuvant use, delivery method etc. New generation vaccines have several advantages over conventional vaccines such as improved immunogenicity, reduced side effects, broad spectrum coverage, long lasting protection, and easy production and storage. However, new generation vaccines also have some disadvantages such as high cost, low availability, low stability, and ethical issues.


There are various types of new generation vaccines such as subunit vaccines, peptide vaccines, DNA vaccines, RNA vaccines, recombinant vector vaccines, virus-like particle (VLP) vaccines etc. Each type has its own advantages and disadvantages depending on the type of antigen, the type of immune response, the type of delivery system etc. Subunit vaccines use purified or synthetic antigens that are derived from pathogens or tumors. Peptide vaccines use short sequences of amino acids that mimic epitopes (parts of antigens that bind to antibodies or T cells) of pathogens or tumors. DNA vaccines use plasmids (circular DNA molecules) that encode antigens of pathogens or tumors. RNA vaccines use messenger RNA (mRNA) molecules that encode antigens of pathogens or tumors. Recombinant vector vaccines use attenuated (weakened) or modified viruses or bacteria that carry genes of antigens of pathogens or tumors. VLP vaccines use self-assembled structures that resemble viruses but lack genetic material and are composed of antigens of pathogens or tumors.


Some examples of new generation vaccines are hepatitis B subunit vaccine for prevention of hepatitis B infection, malaria peptide vaccine for prevention of malaria infection, COVID-19 mRNA vaccine for prevention of COVID-19 infection, Ebola recombinant vector vaccine for prevention of Ebola infection, human papillomavirus (HPV) VLP vaccine for prevention of cervical cancer etc.


Conclusion




In conclusion, pharmaceutical biotechnology is a branch of science that applies the principles and techniques of biotechnology to the development, production, analysis, and delivery of drugs. It encompasses a wide range of topics such as immobilization, recombinant DNA technology, monoclonal antibodies, protein and peptide delivery, gene delivery, molecular principles of drug targeting, and new generation vaccines. Pharmaceutical biotechnology has revolutionized the field of medicine by providing novel solutions for diagnosis, prevention, treatment, and cure of various diseases.


One of the most comprehensive books on pharmaceutical biotechnology is "Pharmaceutical Biotechnology" by S. P. Vyas and V. Dixit. The authors are eminent professors at Dr. Hari Singh Gour University in India with extensive experience in teaching, research, consultancy, administration, publication, patenting, editing, reviewing, organizing conferences/workshops/seminars/symposia etc. in various fields related to pharmaceutical sciences. The book covers all important biotechnological topics of academic and industrial interests with quality concepts and potential problems in research in biotechnology and newer drug delivery systems. The book is divided into eight chapters that cover basic topics for both undergraduates and postgraduates.


Pharmaceutical biotechnology is a dynamic and evolving field that offers many opportunities and challenges for future research and development. Some of the future perspectives and challenges for pharmaceutical biotechnology are: developing more effective and safer drugs and delivery systems, exploring new sources and targets of drugs and delivery systems, integrating multidisciplinary approaches and technologies such as nanotechnology, bioinformatics, artificial intelligence etc., addressing ethical, social, legal, and regulatory issues related to pharmaceutical biotechnology etc.


FAQs




Here are some frequently asked questions related to the article topic:



  • What is the difference between biotechnology and pharmaceutical biotechnology?



Biotechnology is a broad term that refers to the use of living organisms or their products for industrial or commercial purposes. Pharmaceutical biotechnology is a branch of biotechnology that focuses on the development, production, analysis, and delivery of drugs.


  • What are some examples of drugs that are produced by pharmaceutical biotechnology?



Some examples of drugs that are produced by pharmaceutical biotechnology are human insulin for diabetes treatment, human growth hormone for growth disorders, erythropoietin for anemia treatment, interferons for viral infections and cancers, vaccines for infectious diseases etc.


  • What are some advantages and disadvantages of immobilization?



Some advantages of immobilization are increased stability, reusability, ease of separation, enhanced activity, reduced inhibition, improved specificity, and reduced cost. Some disadvantages of immobilization are loss of activity, diffusion limitations, mass transfer resistance, leakage, and contamination.


  • What are some advantages and disadvantages of recombinant DNA technology?



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