This document provides an overview of a course on pharmaceutical biotechnology. It introduces the instructor and outlines the course objectives, syllabus, and assessment scheme. The course will cover topics such as the development of pharmaceutical biotechnology, manufacturing processes for biotech compounds, pharmaceutical development strategies, gene therapy, and formulation of pharmaceutical and biopharmaceutical products. Students will gain an understanding of biotechnology applications in pharmaceutical and biopharmaceutical fields and drug design and development processes.
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This document provides an overview of a course on pharmaceutical biotechnology. It introduces the instructor and outlines the course objectives, syllabus, and assessment scheme. The course will cover topics such as the development of pharmaceutical biotechnology, manufacturing processes for biotech compounds, pharmaceutical development strategies, gene therapy, and formulation of pharmaceutical and biopharmaceutical products. Students will gain an understanding of biotechnology applications in pharmaceutical and biopharmaceutical fields and drug design and development processes.
This document provides an overview of a course on pharmaceutical biotechnology. It introduces the instructor and outlines the course objectives, syllabus, and assessment scheme. The course will cover topics such as the development of pharmaceutical biotechnology, manufacturing processes for biotech compounds, pharmaceutical development strategies, gene therapy, and formulation of pharmaceutical and biopharmaceutical products. Students will gain an understanding of biotechnology applications in pharmaceutical and biopharmaceutical fields and drug design and development processes.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as PPT, PDF, TXT or read online from Scribd
This document provides an overview of a course on pharmaceutical biotechnology. It introduces the instructor and outlines the course objectives, syllabus, and assessment scheme. The course will cover topics such as the development of pharmaceutical biotechnology, manufacturing processes for biotech compounds, pharmaceutical development strategies, gene therapy, and formulation of pharmaceutical and biopharmaceutical products. Students will gain an understanding of biotechnology applications in pharmaceutical and biopharmaceutical fields and drug design and development processes.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as PPT, PDF, TXT or read online from Scribd
Practical: 20% Assignment: 10% Final examination: 40% Overview ① Introduction ② Manufacturing processes of Biotech compounds used in Pharmaceutical and Biopharmaceutical fields ③ Pharmaceutical Development Strategies ④ Gene therapy ⑤ Formulation for a pharmaceutical and biopharmaceutical Chapter I: INTRODUCTION What is Pharmaceutical?
Pharmaceutical substances form the backbone of modern
medicinal therapy
Most traditional pharmaceuticals are low molecular weight
organic chemicals (Table 1.1).
A range of pharmaceutical substances (e.g. hormones and
blood products) are produced by/extracted from biological sources. Table 1.1 Sometraditional pharmaceutical substances that are generally produced by direct chemical synthesis
‘Biopharmaceutical’ and ‘Products of pharmaceutical biote
chnology’ or ‘Biotechnology medicines’
‘Biologic’ refers to any pharmaceutical product produced b
y biotechnological endeavour. In pharmaceutical circles, ‘biolo gic’ generally refers to medicinal products derived from blood, as well as vaccines, toxins and allergen products.
‘Biotechnology’ has a much broader and long-established me
aning. Essentially, it refers to the use of biological systems (e.g. cells or tissues) or biological molecules (e.g. enzymes or anti bodies) for/in the manufacture of commercial products. Pharmaceutical Biotechnology Modern biotechnology have had major impact on Pharmaceutical and Biopharmaceutical fields. Cultivation of cells used in pharmaceutical and biopharmaceutical fields. Gene Disruption Expression of Genes Mutasynthesis Recombinant DNA technology Hybridoma technology X-crystallization application Formulation for a pharmaceutical and biopharmaceutical Gene therapy What is the Impact of Pharmaceutical Biotechnology on the Drug Development Process?
Reducing cost
Accelerating the Drug Development Process: development and
manufacture of therapeutic proteins and nucleotides.
Maintaining High Standards in Quality Assurance
The age of biopharmaceuticals
Biomedical research continues to broaden our understanding of the mo
lecular mechanisms underlining both health and disease.
Research undertaken since the 1950s has pinpointed a host of proteins
produced naturally in the body that have obvious therapeutic application s.
Example
Interferons and interleukins (which regulate the immune response)
Growth factors, such as erythropoietin (EPO; which stimulates red blood cell production) The age of biopharmaceuticals
The pharmaceutical potential of regulatory molecules was generally
appreciated, their widespread medical application was in most cases rendered impractical due to the tiny quantities in which they were nat urally produced.
The advent of recombinant DNA technology (genetic engineering) a
nd monoclonal antibody technology (hybridoma technology) overcam e many such difficulties, and marked the beginning of a new era of t he pharmaceutical sciences. The age of biopharmaceuticals
Recombinant DNA technology has had a fourfold positive impact
upon the production of pharmaceutically important proteins:
It overcomes the problem of source availability.
It overcomes problems of product safety. It provides an alternative to direct extraction from inappropriate/dangerous source material. It facilitates the generation of engineered therapeutic proteins displaying some clinical advantage over the native protein product. Biopharmaceuticals: current status and future prospects
By mid 2006, some 160 biopharmaceutical products had gai
ned marketing approval in the USA and/or EU (Table 1.3)
Protein-based therapeutic agents: hormones, blood fac
tors and thrombolytic agents, as well as vaccines and mon oclonal antibodies.
Nucleic-acid-based products: ‘Vitravene’, an antisense oli
gonucleotide, and ‘Macugen’, an aptamer. Biopharmaceuticals: current status and future prospects
Many of the initial biopharmaceuticals approved were simple
replacement proteins (e.g. blood factors and human insulin).
The vast majority of approved recombinant proteins have bee
n produced in the bacterium E. coli, the yeast S. cerevisiae or in animal cell lines (most notably Chinese hamster ovary (CHO) cel ls or baby hamster kidney (BHK) cells. Biopharmaceuticals: current status and future prospects
Although most biopharmaceuticals approved to date are intended for
human use, a number of products destined for veterinary application have also come on the market.
Recombinant bovine GH (Somatotrophin), which was approved in the
USA in the early 1990s and used to increase milk yields from dairy cattle.
Veterinary biopharmaceuticals include a range of recombinant vaccines
and an interferon-based product. Table 1.3 Summary categorization of biopharmaceuticals approved for general medical use in the EU and/or USA by 2006 What can you do by the end of this course?
Overview the development of pharmaceutical biotechnology
Outline the applications of biotechnology in pharmaceutical and biopharmaceutical fields Understand how to drug design and drug development Understand the Regulations in pharmaceutical manufacturing What topics will be covered? Pharmaceutical and Biopharmaceutical production Pharmaceutical practice Manufacturing processes of Biotech compounds used in Pharmaceutical
and Biopharmaceutical fields
Pharmaceutical Development Strategies Nucleic-acid and cell-based therapeutics REVISIONS Procaryotic and Eucaryotic Cells in Biotech Production
Fermentation of microorganisms or the use of yeast and plants in
the production of important pharmaceuticals has been well established.
The promises of genomics in drug discovery and drug production,
which were eagerly embraced in the mid-1990s, have now been fulfilled in many areas.
A systematic integration of technologies results in a superior output
of data and information, and thereby enhances our understanding of biological function – drug discovery and development is hence facing a new age. Procaryotic and Eucaryotic Cells in Biotech Production
Bacterial strains, especially Actinomycetes have been used in biotech prod
uction and drug discovery for years.
The productivity of yeast and other fungi in a variety of different processe
s has improved significantly since genetic methods have been introduced.
Transgenic plant Biotech
Figure 1. Convergence of genomic and clinical knowledge in po stgenomic new drug development and healthcare The overall discovery/development process can be divided into four convenient steps
Target Selection and Validation
Choice Between Small-molecule and Macromolecule Platforms Definition of Target Product Profile Drug Discovery and Development