Biotechnology Product Development Overview

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Questions and Answers

What is the primary function of amylase?

  • To break down starch to sugar (correct)
  • To break down lipids
  • To break down proteins
  • To synthesize glucose

In an ELISA, the purpose is to recognize an antigen and measure its volume.

False (B)

What does rDNA stand for?

Recombinant DNA

The ______ assay utilizes antibody-antigen specificity to recognize specific molecules.

<p>ELISA</p> Signup and view all the answers

Match the following terms with their correct descriptions:

<p>Amylase = Enzyme that breaks down starch ELISA = Assay for detecting proteins Western blot = Technique to visualize proteins on a membrane Nutraceuticals = Herbal remedies with potential health benefits</p> Signup and view all the answers

What indicates decreasing amounts of protein in the activity assay?

<p>Lighter blue color (D)</p> Signup and view all the answers

Western blots can confirm the presence of proteins at high concentrations.

<p>False (B)</p> Signup and view all the answers

What is a major concern regarding herbal dietary supplements?

<p>Many are not approved by the FDA and their effectiveness is anecdotal.</p> Signup and view all the answers

Which of the following is an example of a biotechnology product derived from animal sources?

<p>Insulin from the pancreas of livestock (A)</p> Signup and view all the answers

The Comprehensive Product Development Plan (CPDP) includes steps such as estimating market size and checking for patent protection.

<p>True (A)</p> Signup and view all the answers

What must researchers do with a substance chosen as a potential product?

<p>Conduct assays to test for its presence, activity, and concentration.</p> Signup and view all the answers

The foxglove plant is used to regulate __________.

<p>irregular heartbeat</p> Signup and view all the answers

Match the following steps in a Comprehensive Product Development Plan (CPDP) with their descriptions:

<p>Estimating market size = Determining potential sales volume Identifying product sources = Finding raw material sources for production Conducting preliminary data analysis = Evaluating product feasibility Securing patent protection = Preventing competition in the market</p> Signup and view all the answers

Which assay is primarily used to determine the presence and concentration of proteins?

<p>Enzyme-Linked Immunosorbent Assay (ELISA) (B)</p> Signup and view all the answers

Antibiotic resistance is a significant issue in testing the effectiveness of antibiotics and antimicrobials.

<p>True (A)</p> Signup and view all the answers

What role do CHO cells play in protein product development?

<p>They are used as host cells for producing recombinant proteins.</p> Signup and view all the answers

Flashcards

Comprehensive Product Development Plan (CPDP)

A plan that helps determine if a product is worth making. It considers factors like market size, need, preliminary data, patent protection, and profitability.

Assay

A method of measuring the concentration, activity, and presence of a substance. It's essential for product development and quality control.

Harnessing the Potential of Materials Produced in Nature

The process of using plant and animal parts as sources of products, applying scientific knowledge to extract useful materials.

Testing Antibiotics and Antimicrobials

Determining the effectiveness of antibiotics and antimicrobials by measuring their ability to inhibit the growth of bacteria.

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CHO Cells

A type of cell used in protein product development, particularly for producing therapeutic proteins.

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Recombinant DNA Protein Product Pipeline

A series of steps essential for producing recombinant DNA protein products, including gene cloning, cell expression, purification, and formulation.

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Identifying the Product's Market

Determining whether a product is needed, who will use it, and whether the market is large enough to support its sales.

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Potential Products from Nature

Substances from natural sources, like animal organs or plants, often used to create pharmaceuticals and healthcare products.

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Amylase Activity Assay

Amylase is an enzyme that breaks down starch into sugar. The activity of amylase can be observed by its ability to lighten the color of a starch/iodine mixture. The lighter the color, the more active the amylase.

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What is ELISA?

ELISA stands for Enzyme-Linked Immunosorbent Assay. It's a highly specific molecular assay that identifies and measures concentrations of specific proteins or antigens in a mixture.

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How does ELISA work?

ELISA combines two important phenomena: 1) antibody-antigen specificity, which only recognizes very specific molecules and 2) enzyme activity on colorimetric reagents for visualization.

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What is a Western Blot?

A Western blot is a technique used to identify and quantify proteins in a sample. Proteins are separated based on size on a gel, then transferred to a membrane. Antibodies, specific to the target protein, are used to visualize the protein's presence on the membrane.

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How are proteins transferred in a Western blot?

In a Western blot, proteins are transferred from the PAGE gel to the blot transfer membrane using electrical current. This process moves the proteins from the gel to the membrane for further analysis.

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What are Nutraceuticals?

Nutraceuticals are herbal remedies derived from food and plants that may provide pharmaceutical or nutritional benefits. These products often claim to have antimicrobial properties.

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What is Recombinant DNA (rDNA)?

rDNA refers to recombinant DNA, which is DNA created by combining genetic material from two different sources. This technology allows for the production of proteins, such as insulin, in large quantities.

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When was rDNA first produced?

rDNA was first produced in the mid-1970s and has opened up new avenues for producing protein products. This technology has greatly impacted various fields, including medicine, agriculture, and biotechnology.

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Study Notes

Identifying a Potential Biotechnology Product

  • Biotechnology products are derived from plant and animal sources.
  • Extracting compounds from these sources presents challenges.
  • A Comprehensive Product Development Plan (CPDP) evaluates potential products:
    • Market need and size are assessed.
    • Data on product efficacy and patent protection is considered.
    • Profitability and production costs are evaluated.
  • Preliminary data on a potential product's efficacy and the patentability of the product is crucial.
  • Product manufacturing feasibility and profitability are assessed.

Sources of Potential Products

  • Plant and animal organs have historically been used for various purposes.
  • Modern biotechnology uses plant and animal parts for new products.
    • Pancreas from livestock is used to produce insulin.
    • The foxglove plant regulates irregular heartbeats.

Harnessing the Potential of Natural Products

  • Some natural products are produced in small quantities.
  • Methods of increasing production of these products are needed.

The Use of Assays

  • Researchers assess potential products by evaluating their presence, activity, and concentration.
  • Assays are conducted throughout the development process to assess potency, toxicity, and stability.

Enzyme-Linked Immunosorbent Assay (ELISA)

  • ELISA is a crucial molecular assay.
  • It uniquely distinguishes a single protein from a complex mixture.
  • Antibody-antigen specificity and enzymatic reactions on colorimetric reagents help in visualization.
  • ELISAs are used to quantify antigens.

Western Blots

  • Protein bands on a PAGE gel are transferred to a membrane (PVDF or nitrocellulose).
  • Western blotting confirms the presence of specific proteins, even at low concentrations.

Looking for New Products in Nature

  • Herbal remedies, often from rainforests, represent a source of nutraceuticals:
    • Food and plant-derived remedies may have pharmaceutical or nutritional benefits.
    • Antimicrobial activity from herbal extracts is of current interest.
  • Herbal supplements' efficacy is often debated.
  • Many herbal supplements lack FDA approval and evidence of effectiveness is often anecdotal.

Recombinant DNA (rDNA) Protein Products

  • Recombinant DNA technology emerged in the mid-1970s.
  • Recombinant DNA is produced by combining DNA from different sources.

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