Biotech Basics: Fundamental Principles of the Biotechnology Industry

1. Biotech Basics: Fundamental Principles of the Biotechnology Industry Module 1: Basic Biotech Principles Select Next to continue.

2. Course Author This ISPE course was developed by Jeffery Odum, a globally recognized instructor in the areas of facility design, GMP compliance, and aseptic manufacturing. Take a moment to get to know Jeff Odum by selecting the More Information icon. When you are ready, select Nextto continue with the introduction. Jeffery Odum, Instructor More Information ! Select Next to continue.

3. Course Resources “Biopharmaceutical Manufacturing in the Twenty-First Century – the Next Generation Manufacturing Facility.” ISPE Baseline Guide: Pharmaceutical Engineering Guides for New and Renovated Facilities: Volume 6, Biopharmaceutical Manufacturing Facilities. “Trends in Biopharmaceutical Manufacturing Facility Design: What’s Hot!” Select each item then select Next to continue.

4. Basic Biotech Principles Welcome to Basic Biotech Principles, Module 1 in Biotech Basics: Fundamental Principles of Biotechnology Industry. This module focuses on the basic scientific principles of biotechnology and the bioprocess as well as providing an understanding of the basic elements of biology important to biotechnology. Listen to the audio and then select Next to continue.

5. Module 1 Learning Goals • Recognize basic biotechnology principles • Review the science of biotechnology • Understand the basic elements of biology important to biotechnology • Discuss the basic scientific principles of the bioprocess Listen to the audio and then select Next to continue.

6. Lesson 1: Recognize Basic Biotechnology Principles Select Next to continue.

7. SME: Please confirm that the phrase “use products” is correct in the screen text and VO. What is Biotechnology? While the science as we know it is new, the basic principles have been around for a very long time. Biotechnology is the culmination of over 8,000 years of human experience using living organisms and the process of fermentation to make use products for mankind. Listen to the audio and then select Next to continue.

8. Modern Biotechnology Modern biotechnology was first identified over 90 years ago. Karl Ereky was a Hungarian architect/engineer who envisioned a biochemical age similar to the stone age and iron ages. Biotechnology is “all lines of work by which products are produced from raw materials with the aid of living things.” -- Karl Ereky,1919 Listen to the audio and then select Next to continue.

9. Useful Products from Biotech Applications Beer Wine Biotech Applications Cheese Bread Biopharmaceutical Drugs Listen to the audio and then select Next to continue.

10. Biotechnology Definition Although this is a more modern definition, it is interesting that even this definition seems to be changing rapidly as the technologies continue to develop and advance within the industry. Biotechnology is a combination of advances in our understanding of molecular and cell biology and human genetics, and how the human immune system fights disease. Select the box and then select Next to continue.

11. Bioscience Subsectors Devices Therapeutics Research and Development Industrial Products The industrial biotechnology applications listed below are particularly important. • Industrial organic chemicals • Agricultural chemicals • Human health care • Detection and treatment of diseases • Human growth • Vaccines • Forensics • Veterinary science • Organic chemicals • Fuels • Agriculture • Crop yields • Pesticides • Fertilizers • Food processing • Aquaculture • Waste management • Wastewater treatment • Bio-remediation Select each item and then select Next to continue.

12. Knowledge Check Directions [placeholder for standard knowledge check directions]

13. The basic principles of biotechnology are relatively new concepts. • True • False Knowledge Check Submit Select the best response and then select Submit.

14. Which of the following are subsectors of the biosciences? • Therapeutics • Industrial products • Devices • Research and development • All of the above Knowledge Check Submit Select the best response and then select Submit.

15. Lesson 2: Review the Science of Biotechnology Select Next to continue.

16. Cell Structure This image is a cutaway of a mammalian cell. Cells have a common, basic structure. As you will see, the components of the cell are important to the understanding of the science. Roll over each term to identify the cell structure. Roll over each term and then select Next to continue.

17. The “power station” of the cell. The Cell as a Manufacturing Plant In simple cells like bacteria there are thousands of different pieces of “equipment” that must be linked together, regulated, and work in harmony for the cell to grow and reproduce. Not only does this “chemical plant” make products, but it regularly replicates itself in rapid manner by dividing. Select each term to learn more about its function in the cell. Polysomes Mitochondrion “The production plant” of the cell. Endoplasmic reticulum Vesticle Nucleus Pore The “roadways” of the cell. Select each term and then select Next to continue.

18. The “storage tank” of the cell. The “command center” of the cell. The Cell as a Manufacturing Plant In simple cells like bacteria there are thousands of different pieces of “equipment” that all must be linked together, regulated, and work in harmony for the cell to grow and reproduce. Not only does this “chemical plant” make products, but it regularly replicates itself in rapid manner by dividing. Select each term to learn more about its function in the cell. Polysomes Mitochondrion The “gateway” of the cell. Endoplasmic reticulum Vesticle Nucleus Pore Select each term and then select Next to continue.

19. DNA, Proteins, and Genes In addition to knowing the parts and functions of a cell, we also need to review three additional elements: DNA, proteins, and genes. We will address each topic in greater depth in this lesson. Select Next to continue.

20. DNA • DNA is the basic genetic material. • DNA consists of: • Sugar • Phosphate • Four nitrogen bases Listen to the audio and then select Next to continue.

21. The Four Nucleotide Bases of DNA Adenine Thymine Hydrogen bonds Guanine Cytosine Listen to the audio and then select Next to continue.

22. DNA Structure 1 2 Listen to the audio and then select Next to continue.

23. The DNA Language Listen to the audio and then select Next to continue.

24. The DNA Code A string of bases in DNA may look something like this: AGCTTCCGATCGGTA However, our DNA language is read in three-letter combinations. So the above bases would be read like this: AGC, TTC, CGA, TCG, GTA Each of the three letter words above is a codon that defines an amino acid: Serine, Phenylalanine, Arginine, Serine, Valine Select each item and then select Next to continue.

25. DNA and Proteins DNA is universal code. Three-letter codon is the code for an amino acid. Same triplet of letters is always the code for the same amino acid. Amino acids used to build proteins, which are the building blocks of DNA. There are 20 amino acids, each with its own chemical properties. Listen to the audio and then select Next to continue.

26. Chemical Properties and Protein Structure 2 • Chemical properties of a protein • Specific sequence of amino acids • The way the amino acid chain is twisted and folded in the three dimensional shape • Specific sequence of nucleotides • Chemical interactions between amino acids 3 Listen to the audio and then select Next to continue.

27. Roles of Proteins Proteins have four major roles. Select the role below to learn more about what proteins do. Provide structure Provide transport Act as catalysts Control cellular processes Select each item and then select Next to continue.

28. Therapeutic Applications of Proteins The value of human proteins in treating disease has long been known. • For example, some proteins are useful therapeutically and diseases caused by a protein deficiency can be treated with the human protein itself. Only tiny quantities can be extracted from human tissue. The goal of biotechnology is to produce sufficient amounts of human protein of high quality. Listen to the audio and then select Next to continue.

29. Denatured Proteins The chemical bonds that hold a protein together are weak and can easily be broken or altered by environmental conditions such as temperature, pH, and salt concentration. If a protein becomes denatured (loses its proper structure), then the protein product is ruined! Select Next to continue.

30. The “Language of Life” The analogy of DNA to language makes it easier to understand the science. Just like language has certain attributes, such as letters, words, and sentences, so does DNA with its nitrogen bases, amino acids, and genes. Select each item and then select Next to continue

31. History of Genetic Engineering Today 1962 1944 Select each circle and then select Next to continue.

32. Genetic Engineering While every cell in an individual organism has the same DNA units, different segments of DNA coding tell individual cells how to differentiate (what to do or what to produce, such as proteins, enzymes, etc.). Coding the human genome was so important because scientists now know what each gene does, making genetic engineering possible. Genetic engineering uses recombinant DNA technology to transplant and/or combine genetic information from one organism to another. Listen to the audio and then select Next to continue.

33. Cells have a common basic structure. • True • False Knowledge Check Submit Select the best response and then select Submit.

34. Proteins are the major structural and regulatory molecules essential for life. • True • False Knowledge Check Submit Select the best response and then select Submit.

35. Proteins are made up of ______ amino acids and each has its own chemical properties. • 20 • 100 • 32 • 4 • 56 Knowledge Check Submit Select the best response and then select Submit.

36. Proteins: • Provide structure. • Provide transport. • Act as catalysts. • Control cellular processes. • All of the above. Knowledge Check Submit Select the best response and then select Submit.

37. Lesson 3: Understand the Basic Elements of Biology Important to Biotechnology Select Next to continue.

38. What are Biologics? Biologics are biological therapeutic products that generally encompass any protein, virus, vaccine, blood product, or gene transfer product. We are going to focus on human therapeutics. • Therapeutic proteins are proteins that are produced in biological organisms or in recombinant DNA technology. • These proteins include: • Monoclonal antibodies. • Cytokines. • Growth factors. Listen to the audio and then select Next to continue.

39. Biologics vs. Small Molecule Drugs It is important that we understand the difference between biologics and pharma-derived products. Most of you will have never taken a biologic drug, so your frame of reference will be tablets and pills. Select each type of product below to learn more about how they are different. Biologics Small Molecule Drugs • Compromise most traditional pharmaceutical drugs • Developed via chemical synthesis • Taken orally • Absorbed through the intestine walls into the bloodstream. • Usually designed to block targets • Very fragile molecules that easily degrade in the digestive system • Injected into bloodstream • Designed to interact with molecules outside the cell • Typically more difficult and costly to manufacture Select each item then select Next to continue.

40. So, Why Biologics? 1 2 Listen to the audio and then select Next to continue.

41. Developing a Recombinant Protein • Mix recombinant plasmid with host cells so transform-ation and cloning occur. • Conduct aseptic filtration and processing for contamination control. • Conduct assay development and animal testing. • Conduct product recovery, formulation, and quality control. Create recombinant plasmid • Grow large scale cell culture. • Grow small scale cell culture. Listen to the audio and then select Next to continue.

42. Create Recombinant Plasmid 1 3 2 Listen to the audio and then select Next to continue.

43. Transformation and Cloning Listen to the audio and then select Next to continue.

44. Small Scale Cell Culture 1. Listen to the audio and then select Next to continue.

45. Assay Development and Animal Testing 1. Listen to the audio and then select Next to continue.

46. Large Scale Cell Culture 1. Listen to the audio and then select Next to continue.

47. Product Recovery, Formulation, and Quality Control 1. Listen to the audio and then select Next to continue.

48. Contamination Control Contamination is the presence of unwanted microbes that can have an adverse impact on the product. Contamination must be prevented in aseptic processing. Listen to the audio and then select Next to continue.

49. Aseptic Filtration and Processing Aseptic Filtration Aseptic Processing • Used to sterilize products that cannot be terminally sterilized in their final container. Select each tab then select Next to continue.

50. Aseptic Filtration and Processing Aseptic Filtration Aseptic Processing • Designed to achieve a sterile product, but this may not always be the end result. • Techniques are often associated with the formulation, filling, and sealing of the drug product into its final delivery means. Select each tab then select Next to continue.