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Biotechnology - Mid > Lec5 | Pharmaceutical Biotechnology > Flashcards

Lec5 | Pharmaceutical Biotechnology Flashcards

1
Q

What two branches of science does pharmaceutical biotechnology combine?

A

Pharmaceutical biotechnology is a combination of pharmaceutical science and biotechnology.

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2
Q

What is the focus of pharmaceutical science?

A

Pharmaceutical science focuses on the discovery, development, compounding and dispensing of drug products.

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3
Q

What does biotechnology utilize for manufacturing products, and give some examples of biological systems and molecules mentioned in the definition?

A

Biotechnology uses and/or manipulates biological systems or biological molecules for manufacturing products.

The definition mentions cells or tissues as examples of biological systems, and enzymes or antibodies as examples of biological molecules.

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4
Q

What is the main objective of biotechnology?

A

Biotechnology has the goal to manufacture commercial products to improve human health.

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5
Q

When was DNA successfully transferred from one life form to another for the first time?

A

in 1973.

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6
Q

How many types of biotechnology are there?

A
  • Red biotechnology is for medical and pharmaceutical applications.
  • White or gray biotechnology is focused on industrial applications.
  • Green biotechnology deals with agriculture.
  • Gold biotechnology includes bioinformatics and data.
  • Blue biotechnology is used in marine and aquatic environments.
  • Yellow biotechnology addresses food production.
  • Violet biotechnology relates to the governance of ethical considerations.
  • Dark biotechnology is related to warfare.
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7
Q

What are the stated aims of pharmaceutical biotechnology?

A

the development of novel therapeutics, personalized medicine, improvement of manufacturing processes and the development of advanced drug delivery systems.

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8
Q

What is one aim of pharmaceutical biotechnology that involves the molecular level of disease?

A

The development of novel therapeutics that target diseases at the molecular level.

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8
Q

What kind of treatments can the “development of novel therapeutics” offer?

A

The development of novel therapeutics can offer treatment for conditions difficult to address with traditional synthetic drugs.

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9
Q

What is the aim of pharmaceutical biotechnology related to “personalized medicine”?

A

One aim of pharmaceutical biotechnology is to design and produce tailored drugs that are adapted to each person’s genetic makeup.

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10
Q

What is the goal of drugs tailored to each person’s genetic makeup?

A

The goal of drugs tailored to each person’s genetic makeup is to maximize efficacy and minimize adverse side effects.

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11
Q

What is one goal of pharmaceutical biotechnology in relation to manufacturing processes?

A

One goal of pharmaceutical biotechnology is the improvement of manufacturing processes.

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12
Q

What does the goal of improved manufacturing processes involve?

A

The goal of improved manufacturing processes involves enhancing the efficiency, scalability, and safety of drug production.

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13
Q

What is an aim of pharmaceutical biotechnology related to “drug delivery systems”?

A

An aim of pharmaceutical biotechnology is the development of advanced drug delivery systems.

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14
Q

What is the intent of advanced drug delivery systems?

A

The intent of advanced drug delivery systems is using technologies that are precise, with minimal dosing to ensure patient compliance.

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15
Q

List the various biotechnological techniques used.

A

DNA sequencing, Recombinant DNA technology, Monoclonal Antibodies, Protein Engineering, Gene Therapy, Gene Editing (CRISPR-Cas9), and Transgenic Animals.

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16
Q

What is the purpose of DNA sequencing in the context of pharmaceutical biotechnology?

A

DNA sequencing identifies mutations causing disease and guides personalized therapies.

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17
Q

What does Recombinant DNA technology do?

A

Recombinant DNA technology combines DNA sequences from different sources to produce therapeutic proteins such as insulin and growth hormones.

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18
Q

What is the technique to produce monoclonal antibodies?

A

Hybridoma cells are used to produce large quantities of identical monoclonal antibodies.

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19
Q

What medical uses are there for Monoclonal Antibodies?

A

Monoclonal antibodies are used in cancer therapy and for the treatment of autoimmune diseases such as rheumatoid arthritis.

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20
Q

What is the focus of protein engineering?

A

The focus of protein engineering is the process of modifying proteins to improve their stability, efficacy, and specificity.

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21
Q

How is protein engineering used for the development of new treatments?

A

Protein engineering is used to develop new therapeutics with improved properties.

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22
Q

What does gene therapy introduce?

A

Gene therapy introduces genetic material to treat or prevent disease, replacing or adding beneficial genes.

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23
Q

What are the capabilities of Gene Editing with CRISPR-Cas9?

A

A gene editing tool that allows scientists to make precise cuts in DNA.

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24
Q

What therapeutic potential is associated with Gene Editing with CRISPR-Cas9?

A

Gene Editing with CRISPR-Cas9 has the potential to treat genetic diseases by correcting the underlying genetic mutations.

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25
Q

What role do transgenic animals play?

A

Transgenic animals, genetically modified, produce human proteins for therapy, especially those difficult to obtain otherwise.

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26
Q

What are biologics derived from?

A

Biologics are products manufactured in, extracted from, or semi-synthesized from biological sources.

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27
Q

What are some uses for biologics?

A

Biologics are applicable to the prevention, treatment or cure of a disease or condition of humans.

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28
Q

What is the general description of biologics in regards to their molecular nature?

A

Biologics are large, complex molecule mixtures.

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29
Q

How easily can biologics be identified and characterized?

A

Biologics are not easily identifiable and characterized.

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30
Q

How sensitive are biologics, to temperature and microbial contamination?

A

Biologics are heat sensitive and susceptible to microbial contamination.

31
Q

What types of manufacturing protocols are applied in the production of biologics?

A

Strict regulations are followed in the manufacturing of biologics.

32
Q

What are some sources of biologics?

A

Mammalian cells, plant cells, bacteria, viruses, fungi, and transgenic cells or organisms are sources of biologics.

33
Q

What are some types of biologics?

A

Fluids, such as blood and its components, solids, such as tissue and faeces, recombinant proteins like vaccines and antibodies, nucleic acids, stem cells for cell based therapies, allergenic extracts, serums, and toxins and antitoxins are types of biologics.

34
Q

When were biopharmaceuticals first used?

A

Biopharmaceuticals were first used in the 1980s.

35
Q

What kind of biomolecules are biopharmaceuticals, in terms of function and chemistry?

A

Biopharmaceuticals are a class of therapeutic proteins.

36
Q

How are biopharmaceuticals produced, using modern technologies?

A

Biopharmaceuticals are produced by modern biotechnological techniques.

37
Q

When did modern biotechnological techniques for the production of biopharmaceuticals start to develop?

A

Modern biotechnological techniques started to develop in 1973.

38
Q

By what method are therapeutic proteins produced, using biopharmaceutical methods?

A

Therapeutic proteins are produced using genetic engineering.

39
Q

By what method are monoclonal antibodies produced using biopharmaceutical methods?

A

Monoclonal antibodies are produced using hybridoma technology.

40
Q

What three types of biomolecules can biologics contain?

A

Biologics can contain sugar, protein, or nucleic acid or a combination.

41
Q

What are the two main categories that biologics are classified under?

A

Biologics are classified under the categories of biopharmaceutical and non-biopharmaceutical.

42
Q

How are biopharmaceuticals produced?

A

Biopharmaceuticals are produced by modern biotechnology techniques that involve manipulations at the molecular level.

43
Q

What are two types of biologics considered to be “non-biopharmaceutical”?

A

Blood and organ donation, as well as Botox, are types of biologics considered to be “non-biopharmaceutical”.

44
Q

Where is the botulinum toxin found in “Botox” extracted from?

A

The botulinum toxin in “Botox” is extracted from bacteria.

45
Q

What is the general method of production of synthetic drugs?

A

Synthetic drugs are products of chemical processes.

46
Q

How are biopharmaceuticals produced, compared to synthetic drugs?

A

Biopharmaceuticals are produced in living cells.

47
Q

How do the molecule sizes compare for synthetic and biopharmaceutical drugs?

A

Synthetic drugs are small molecules, such as acetylsalicylic acid containing about 21 atoms, while biopharmaceuticals are large molecules with around 2000 to 25000 atoms.

48
Q

Compare the complexity of the structures of synthetic versus biopharmaceutical drugs.

A

Synthetic drugs have simple structures and biopharmaceuticals have complex structures.

49
Q

Where are synthetic and biopharmaceutical drugs dispensed?

A

Synthetic drugs are dispensed by retail pharmacies and biopharmaceuticals are dispensed by physicians or hospitals.

50
Q

How easily can the composition of a synthetic drug’s active ingredient be verified?

A

The active ingredient composition of a synthetic drug is easily verified.

51
Q

What primarily defines a biopharmaceutical product, besides its amino acid sequence?

A

The manufacturing process defines a biopharmaceutical product.

52
Q

How easily can the reproducibility of synthetic versus biopharmaceutical drugs be established?

A

Reproducibility is easily established for synthetic drugs, while it is difficult to establish for biopharmaceuticals.

53
Q

How are synthetic and biopharmaceutical drugs typically administered?

A

Synthetic drugs can be administered orally and biopharmaceuticals are administered parenterally.

54
Q

How stable to temperature changes are synthetic drugs versus biopharmaceuticals?

A

Synthetic drugs are relatively stable to temperature changes, but biopharmaceuticals have a sensitivity to temperature change and require complex stabilization.

55
Q

How complex are the mechanisms of action of synthetic drugs versus biopharmaceuticals?

A

Synthetic drugs have straightforward mechanisms of action, while biopharmaceuticals have complex, not fully determined mechanisms that may affect more than 40 genes.

56
Q

What are the immunological effects of most synthetic versus biopharmaceutical drugs?

A

Synthetic drugs are mostly non-immunogenic, while biopharmaceuticals are immunogenic, including having process related impurities.

57
Q

How do the pharmacovigilance processes compare between synthetic and biopharmaceutical drugs?

A

Synthetic drugs have straightforward pharmacovigilance processes, while biopharmaceuticals require more specialized monitoring and detection methods for their pharmacovigilance.

58
Q

How long does it typically take to bring a biopharmaceutical drug from initial discovery to market?

A

It generally takes about 10 to 15 years to bring a biopharmaceutical drug from initial discovery to market.

59
Q

What is the average capital investment required for bringing a biopharmaceutical drug to market

A

The average capital investment is about $2.6 billion to bring a biopharmaceutical drug to market.

60
Q

How does medicine achieve a therapeutic effect based on the ‘magic bullet’ idea?

A

Medicines interact with a protein target, either boosting or inhibiting its function thus achieving its therapeutic effect.

61
Q

How can comparing genetic makeup help identify deregulated proteins related to disease?

A

By comparing the genes of healthy individuals with the genes of individuals with a disease, scientists can hypothesize which proteins or the lack of them are linked to the disease.

62
Q

How does targeted gene editing help to identify deregulated genes involved in disease?

A

By changing one gene at a time and observing the resulting phenotype, scientists can identify possible links between specific gene mutations and diseases if a phenotype has similarities to disease states.

63
Q

What does preclinical development involve?

A

Preclinical development involves Target Validation.

Target validation verifies that the target is involved in the disease pathway, and that modulating the target can lead to a therapeutic effect.

Validation can use in vitro assays, in vivo animal models and human genetic studies.

Some examples of genetic studies mentioned are: knock down, knock in, knock out and mRNA expression.

Animal models of disease, expression profiling, biomarker testing, cell based models, and pharmacological tool compound development are involved in early stages of preclinical development.

Preclinical target selection uses functional analysis, in-vitro or in-vivo genetic manipulation, and disease association genetic testing to find proper therapeutic targets of medication.

64
Q

After validating a target, what are the next two critical steps in the drug development process?

A

After target validation, the next steps are to identify potential products that could influence the target, called “lead identification”, and then to further test the biopharmaceutical product in animal models to assess safety and efficacy.

65
Q

Besides testing, what other alterations to the potential biopharmaceutical candidate might be undertaken during optimization, before moving to clinical trials?

A

Adjustments may be made to prolong the drug’s half-life, increase its affinity to the receptor, or increase its metabolic stability and, after optimization the data from the preclinical trials, are used to support the design of the clinical trials in humans.

66
Q

What is typically the focus of Phase I clinical trials?

A

Phase I trials involve a small study of healthy volunteers, to assess the safety, pharmacokinetics, and pharmacodynamics of the product and to identify the optimal dosing and potential side effects.

67
Q

What characterizes the goals and design of Phase II clinical trials?

A

Phase II trials involve a larger group of patients with the target disease/condition to assess efficacy, and further evaluate safety; trials are also double-blinded and randomized to reduce bias and assess treatment effectiveness.

68
Q

What are the requirements for Phase III clinical trials, including size, design, and the overall objective?

A

Phase III trials use an even larger patient population to confirm the efficacy and safety of the product and they require a multinational, multi-center approach to ensure that the results are reproducible and representative of the target population.

69
Q

Where is data submitted for biopharmaceutical products during regulatory approval?

A

Data is submitted to regulatory agencies such as the Food and Drug Administration (FDA) or European Medicines Agency (EMA).

70
Q

How long can the regulatory approval process take, as stated in the document?

A

The regulatory approval process can take several months to several years.

71
Q

What influences the duration of the regulatory approval process for a biopharmaceutical?

A

The duration of regulatory approval process depends on the complexity of the data, and the number of questions and requests from the regulatory agency.

72
Q

When can large scale manufacturing begin for biopharmaceutical products?

A

Large scale manufacturing of a biopharmaceutical product can begin once the regulatory approval is obtained.

73
Q

What does the manufacturing process involve in biopharmaceutical production?

A

The manufacturing process typically involves the production and formulation of the product into its final dosage form.

74
Q

How is biopharmaceutical manufacturing regulated, and why?

A

The manufacturing process is highly regulated and involves extensive quality control to ensure that the product is safe, effective, and its effect is consistent from batch to batch.

75
Q

What is the general purpose of post-marketing surveillance for pharmaceutical products and devices?

A

Post-marketing surveillance is an ongoing process that is necessary for the monitoring of a product’s safety and effectiveness once it is on the market.

76
Q

What are the four key goals of post-market surveillance?

A

The four key goals are: to detect adverse events as they arise in real-world use, compare new products or treatments to existing options and the standard of care, update clinical guidelines to show where certain patient populations find benefit, and comply with all regulatory requirements.

Biotechnology - Mid (11 decks)

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