Biological Drugs and Applications Quiz

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Questions and Answers

What is necessary to understand the nature and identity of a BLA?

  • Information about the drug itself and its biological source (correct)
  • Data on patient responses to the drug
  • Details about the competitive market for the drug
  • Only information about the drug's chemical composition

Why are BLAs generally more expensive than NMEs?

  • Due to lower production costs
  • Because they have fewer patents associated with them
  • Because they require more complex regulatory processes (correct)
  • Due to higher sourcing costs of synthetic materials

What distinguishes the patenting process of biologics from synthetic drugs?

  • Synthetic drugs do not involve patents in their development
  • Biologics are patented for both the molecule and production methods (correct)
  • Only the drug's chemical formula is patented for biologics
  • Biologics have only one patent covering them

What is necessary to control the consistency of pharmaceutical products from batch to batch?

<p>Determining the level of impurities (A)</p> Signup and view all the answers

What does the processing of DNA involve for obtaining a protein?

<p>Cloning and cultivating host-vector systems (B)</p> Signup and view all the answers

What has legislation allowed concerning branded and generic medications?

<p>A generic can replace a branded medication in therapy. (B)</p> Signup and view all the answers

How many relevant patents are generally associated with a single biologic molecule?

<p>At least four (D)</p> Signup and view all the answers

What is a key difference between BLA (Biologics License Application) and NME (New Molecular Entity)?

<p>BLA compounds are typically flexible while NME compounds are rigid. (A)</p> Signup and view all the answers

Which aspect is NOT a requirement for understanding a BLA?

<p>Knowledge of the healthcare market dynamics (B)</p> Signup and view all the answers

What can result from structural variations in pharmaceutical compounds?

<p>A diverse set of activities in the drug's effects. (A)</p> Signup and view all the answers

Why might more than one technique be necessary to understand the structure of a protein?

<p>Each technique provides unique insights into the protein's structure. (B)</p> Signup and view all the answers

Which of the following is a common misconception about biologics?

<p>They are easier to produce than synthetic drugs (C)</p> Signup and view all the answers

What is one of the critical factors influencing the cost of BLA products?

<p>The regulatory complexities and patenting (C)</p> Signup and view all the answers

What is indicated by the term 'potential site of variations' in polymers?

<p>Any subunit can be modified, leading to variation. (C)</p> Signup and view all the answers

What is a consequence of the ability to produce chemical compounds by various manufacturers?

<p>There is a potential for uniformity in compounds despite different production processes. (B)</p> Signup and view all the answers

Which aspect can lead to modifications in the chemical structure of a compound during production?

<p>Variations introduced during the manufacturing process (B)</p> Signup and view all the answers

Which of the following best describes the process of producing antibiotics?

<p>Antibiotics are primarily produced through organic synthesis to ensure high purity. (B)</p> Signup and view all the answers

What is the key factor that determines the production process of antibiotics?

<p>The cost-effectiveness of the production method (C)</p> Signup and view all the answers

What is a defining characteristic of small molecules?

<p>Their production relies on chemically defined processes. (B)</p> Signup and view all the answers

What does the phrase "chemical-based drugs" refer to?

<p>Drugs produced by chemical reactions. (C)</p> Signup and view all the answers

Which of the following is NOT a characteristic of chemical-based drugs?

<p>Their production relies on complex biological processes. (A)</p> Signup and view all the answers

Why is the consistency of the production process emphasized for chemical-based drugs?

<p>To guarantee identical composition and reliable therapeutic effects. (B)</p> Signup and view all the answers

What is the main difference between biopharmaceuticals and chemical-based drugs?

<p>Biopharmaceuticals are produced by living organisms, while chemical-based drugs are synthesized chemically. (D)</p> Signup and view all the answers

What is the main focus of biotechnology in the pharmaceutical industry?

<p>Producing proteins and antibodies using genetic engineering. (D)</p> Signup and view all the answers

What type of cells are considered eukaryotic?

<p>Both B and C (A)</p> Signup and view all the answers

Which of the following contaminants can affect mammalian cells?

<p>Mycoplasmas (C)</p> Signup and view all the answers

What is a key difference between procaryotic and eukaryotic cells regarding protein production?

<p>Eukaryotic cells can produce glycosylated proteins. (A)</p> Signup and view all the answers

In terms of cellular structure, what is one distinct characteristic of yeast cells compared to bacterial cells?

<p>Yeast cells are simple eukaryotes. (B)</p> Signup and view all the answers

Which viral type is known to infect procaryotic cells but not eukaryotic cells?

<p>Fagi (C)</p> Signup and view all the answers

Which statement about glycosylation is correct?

<p>It can occur in yeast or mammalian cells. (D)</p> Signup and view all the answers

What fundamentally differentiates mammalian cells from bacterial cells in terms of cell structure?

<p>Mammalian cells have a nucleus. (D)</p> Signup and view all the answers

What does the folding of proteins in bacterial cells imply about their structure compared to mammalian cells?

<p>They might not achieve the same folding. (A)</p> Signup and view all the answers

What is the purpose of adding a tracer to the sample loaded into the DNA gel?

<p>To help visualize the migration of the sample in the gel. (B)</p> Signup and view all the answers

Why are the bands representing the primers less intense and more diffuse than the main amplification product bands?

<p>The primers are smaller and more mobile in the gel matrix, resulting in wider and less concentrated bands. (D)</p> Signup and view all the answers

What is the primary reason why the amplified DNA appears as bands on the gel?

<p>The amplified DNA fragments are separated by their molecular weight, with larger fragments migrating slower than smaller ones. (B)</p> Signup and view all the answers

Why are the bands representing unincorporated dNTPs much less intense than the amplified product bands?

<p>Unincorporated dNTPs are much smaller than the amplified product and therefore migrate faster out of the gel. (D)</p> Signup and view all the answers

What is the role of the glycerin added to the sample before loading it onto the DNA gel?

<p>To increase the viscosity of the sample, making it easier to load and preventing it from diffusing too quickly. (A)</p> Signup and view all the answers

Why is ethidium bromide used for staining the DNA gel?

<p>It binds to the DNA and enhances its fluorescence under UV light, revealing the location of DNA bands. (A)</p> Signup and view all the answers

Why is the fluorescence intensity of the primer bands much weaker compared to the amplification product bands?

<p>Ethidium bromide has a lower affinity for single-stranded DNA (primers) compared to double-stranded DNA (amplification product). (A)</p> Signup and view all the answers

What is the purpose of the negative image produced during the gel printing process?

<p>To make the DNA bands more visible as dark bands against a bright background. (C)</p> Signup and view all the answers

What is a significant reason for choosing a bacterial system over a mammalian system for protein expression?

<p>Bacteria can produce larger quantities of protein quickly. (C)</p> Signup and view all the answers

What type of contamination can be a concern when expressing proteins in bacterial systems?

<p>Contamination from proteolytic enzymes during cell lysis. (A)</p> Signup and view all the answers

Which factor is NOT mentioned as a criterion for choosing a bacterial or mammalian cell for protein production?

<p>Source of the genetic material. (C)</p> Signup and view all the answers

Why might monoclonal antibodies pose a challenge when produced in bacterial systems?

<p>The heavy weight and size of the proteins are difficult to process. (C)</p> Signup and view all the answers

What is a key advantage of using mammalian cells for protein expression?

<p>Mammalian cells are capable of post-translational modifications. (D)</p> Signup and view all the answers

Which type of expression system is suitable for obtaining a protein that requires complex folding?

<p>Mammalian cells (C)</p> Signup and view all the answers

What is the main disadvantage of using bacterial cells for expressing proteins with post-translational modifications?

<p>They lack the necessary cellular machinery for such modifications. (A)</p> Signup and view all the answers

What happens to proteins expressed in bacteria during cell lysis?

<p>They are exposed to various contaminants including proteases. (C)</p> Signup and view all the answers

Flashcards

Antibiotics

Secondary metabolites produced by fungi or bacteria used to kill or inhibit bacteria.

Biotechnology in pharmaceuticals

Utilizing living organisms to create drugs, often involving recombinant DNA technology.

Biopharmaceuticals

Drugs produced from biological sources, distinct from chemical drugs.

Small molecules

Chemical-based drugs that are synthesized through chemical processes.

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Production consistency

The reliability of chemical processes to yield the same product each time.

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Controlled processes

Processes that are monitored to ensure quality and purity of pharmaceuticals.

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Recombinant DNA

A technology that combines DNA from different organisms to produce proteins.

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Purity in pharmaceuticals

The degree to which a drug is free from contaminants and impurities.

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Impurities

Unwanted substances in pharmaceuticals affecting quality.

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Batch Consistency

Ensuring uniformity of product across production batches.

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Generic Drugs

Medications that are equivalent to branded versions in efficacy.

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BLA vs NME

BLA (Biologics License Application) are flexible; NME (New Molecular Entity) are rigid.

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Structural Variations

Changes in the structure of compounds affecting their activity.

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Chemicals in Pharma

Many players can create chemical compounds, not just big companies.

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Polymer Subunits

Individual components of polymers that can vary structurally.

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Techniques to Understand Proteins

Multiple methods may be needed to analyze protein structures.

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BLA

Biologics License Application; a request to market a biologic drug.

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Biological source

The origin of a biologic drug, such as DNA from a specific organism.

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Protein processing

The steps taken to produce a protein from DNA using host-vector systems.

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Recombinant proteins

Proteins created through recombinant DNA technology, often used in therapeutics.

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Cost difference in drugs

BLAs are generally more expensive than New Molecular Entities (NMEs) due to complex production.

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Patent complexity

Biological drugs have multiple patents covering molecules and production methods.

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Biologics production method

The specific approach used to create biologics, including biological sourcing and processing.

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Regulatory environment for biologics

The complex rules and regulations governing the approval and production of biologics.

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Gel Electrophoresis

A method used to separate DNA fragments based on size.

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Fluorophores

Molecules that can re-emit light upon excitation, used to label DNA.

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Ethidium Bromide

A dye used to visualize DNA in gels by intercalation.

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Sample Loading

Adding a DNA sample to the wells of a gel for electrophoresis.

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Tracer

A substance added to DNA samples to track their migration in the gel.

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Primer

Short strands of DNA used to initiate amplification during PCR.

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dNTPs

Deoxynucleotide triphosphates; building blocks for new DNA strands.

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Single-stranded vs Double-stranded

Refers to DNA's structure; primers are single-stranded, while intercalating dyes target double-stranded DNA.

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Prokaryotic cells

Simple, unicellular organisms without a nucleus, like bacteria.

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Eukaryotic cells

Complex cells with a nucleus and organelles, like yeast and animal cells.

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Yeast

A type of eukaryotic cell used in fermentation and protein production.

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Animal cells

Eukaryotic cells from mammals, often used for research and production.

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Mycoplasma contamination

Infection caused by bacteria lacking a cell wall, affecting eukaryotic cells.

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Post-translational modifications

Chemical changes to proteins after synthesis, crucial for their function.

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Glycosylation

The addition of sugar chains to proteins, specific to eukaryotic cells.

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Viral contamination in cells

Presence of viruses that can affect different types of cells; prokaryotic vs. eukaryotic.

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Expression System

The biological system used to produce proteins, specific to the type of cell (bacteria or mammalian).

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Protein Size Limitations

Larger proteins can only be produced in eukaryotic cells due to processing difficulties in prokaryotes.

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Protein Yield

The amount of protein produced in a particular cell system; prokaryotes offer higher yield due to rapid replication.

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Cell Lysis

The process of breaking open cells to retrieve proteins; can release contaminants from prokaryotes.

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Contaminants in Protein Production

Unwanted substances that can compromise the purity of the extracted protein.

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Study Notes

Acronyms

  • NDA: new drug application, used to indicate new synthetic drugs needing approval
  • BLA: biological license application, used for regulatory approval of biologicals
  • NME: new (small) molecular entities, more accurate term since 2019
  • Biologic: used in place of BLA

Public Biotech Table Information

  • Biotech company data is often in tables from Public Biotech
  • Top 10 selling biological drugs table examples from 2012:
    • Drug name
    • Manufacturer (lead company)
    • Approved therapeutic uses (that year)
    • Type of molecule
    • Revenue

Biological and Synthetic Drug Characteristics

  • Both biologics and some synthetic drugs have high specificity and selectivity for targets
  • Unlike synthetic drugs, patents for biologics often cover the produced DNA, cells, and modifications

BLA and NME Differences

  • Proteins from recombinant human origin, such as insulin, differ in size and complexity to antibodies and constructs
  • Differences in molecular weights between biologics is significant

Biological Medicine Composition

  • Most biological medicines contain proteins as active substances
  • Sizes and complexities vary widely among different proteins, from simple proteins like insulin to complex proteins such as coagulation factors or monoclonal antibodies

Pipeline

  • Pipeline describes projects under development in a company (discovery, preclinical, clinical phases 1-3, post-marketing)
  • It's often time-consuming and costly, not all products reach the end of the pipeline

Low-Tech and High-Tech Biopharmaceuticals

  • Low-tech biopharmaceuticals use established technologies (like vaccines, sera, toxins, antisera)
  • High-tech products involve more complex technologies (like monoclonal antibodies, recombinant proteins, gene therapy, and stem cells).

Defining Biopharmaceutical

  • The term "biopharmaceutical" covers a wide range of products, including vaccines, antivirals and more
  • The term "biologic" is more related to how the drug is made

Regulatory Differences

  • Biologics have different patent and regulatory requirements from small-chemical entities due to their complexity in production.

Different Drug Qualities

  • Chemical drugs have consistent purity and contents, readily analyzed
  • Differences in biological products production processes make them more complex and harder to characterize

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