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?

Determining the level of impurities (A) Signup and view all the answers

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

Cloning and cultivating host-vector systems (B) Signup and view all the answers

What has legislation allowed concerning branded and generic medications?

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

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

At least four (D) Signup and view all the answers

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

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

Which aspect is NOT a requirement for understanding a BLA?

Knowledge of the healthcare market dynamics (B) Signup and view all the answers

What can result from structural variations in pharmaceutical compounds?

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

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

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

Which of the following is a common misconception about biologics?

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

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

The regulatory complexities and patenting (C) Signup and view all the answers

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

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

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

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

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

Variations introduced during the manufacturing process (B) Signup and view all the answers

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

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

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

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

What is a defining characteristic of small molecules?

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

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

Drugs produced by chemical reactions. (C) Signup and view all the answers

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

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

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

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

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

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

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

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

What type of cells are considered eukaryotic?

Both B and C (A) Signup and view all the answers

Which of the following contaminants can affect mammalian cells?

Mycoplasmas (C) Signup and view all the answers

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

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

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

Yeast cells are simple eukaryotes. (B) Signup and view all the answers

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

Fagi (C) Signup and view all the answers

Which statement about glycosylation is correct?

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

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

Mammalian cells have a nucleus. (D) Signup and view all the answers

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

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

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

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

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

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

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

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

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

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

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

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

Why is ethidium bromide used for staining the DNA gel?

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

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

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

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

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

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

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

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

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

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

Source of the genetic material. (C) Signup and view all the answers

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

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

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

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

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

Mammalian cells (C) Signup and view all the answers

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

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

What happens to proteins expressed in bacteria during cell lysis?

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

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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Description

Test your knowledge on biological drugs, their applications, and key regulatory terms such as NDA and BLA. This quiz covers the differences between biologics and synthetic drugs, as well as insights on biotech company data and drug characteristics. Delve into the world of pharmaceuticals and biotechnology!