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drug final > Biologics and Biosimilars > Flashcards

Biologics and Biosimilars Flashcards

1
Q

What are biologics?

A

biological products, produced from living cells or organisms (cell cultures)
- derived from a variety of natural resources

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2
Q

What are biologics used for?

A
  • treat or cure disease and medical conditions
  • prevent diseases
  • diagnose diseases
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3
Q

What are biologics composed of?

A
  • proteins, nucleic acids or sugars, or combinations of these
  • living entities such as cells and tissues
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4
Q

What are some source materials for biologics?

A
  • mammalian cell-culture
  • bacteria
  • mice
  • humans
  • yeast
  • transgenics
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5
Q

What are some types of biologics?

A
  • blood derivatives
  • proteins
  • human tissues
  • vaccines
  • allergenic extracts
  • cellular and gene therapies
  • xenotransplantation products (one organism to another)
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6
Q

How are biologics manufactured compared to small-molecule drugs?

A
  • many critical process steps (100)
  • fewer critical steps (10)
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7
Q

What form do biologics come in compared to small-molecule drugs?

A
  • injected or infused
  • generally oral solids
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8
Q

How are biologics dispensed compared to small-molecule drugs?

A
  • retail pharmacies
  • doctors or hospitals
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9
Q

What is an example of a peptide biologics?

A

peptides (chains of amino acids)
- insulin
- GLP-1 agonist peptides

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10
Q

How is insulin commercially produced?

A

bacterial production of insulin using genetic engineering with human DNA:
- insert human insulin gene into bacteria
- fermentation tank
- recombinant bacterium produce insulin
- many steps to purify it, then it’s harvested

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11
Q

Where are biologics produced?

A
  • bio-reactors
  • very clean, and strict manufacturing to keep sterile
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12
Q

What are some examples of cell therapy biologics?

A

autologous: patient-specific (both donor and patient)
- TIL
- CAR-T

allogeneic: universal donor

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13
Q

How are tumor-infiltrating lymphocytes made?

A
  • fragmentation of tumor sample and isolating of tumor-infiltrating lymphocytes
  • activation and expansion
  • transfusion
  • genetically engineered cancer-specific T-cells
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14
Q

How are chimeric antigen T (CAR-T) cells made?

A
  • collect blood to get t-cells
  • t-cells are separated and removed (blood is returned)
  • t-cells are genetically altered to have a special CAR receptor
  • grow millions of them
  • chemo is given before CAR T cell therapy
  • new CAR-T cells introduced into bloodstream
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15
Q

What is the purpose of stem cell therapy for Parkinson’s disease?

A

designed to replace the dopamine-producing neurons that are lost

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16
Q

How is stem cell therapy done for Parkinson’s disease?

A

surgery is done to implant neuron precursors into the brain. They now have the potential to reform neural networks have have been affected and restore motor and non motor functions

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17
Q

How is an antibody?

A
  • proteins that play a role in our immunity against pathogens
  • we generate antibodies that bind to antigens present in these pathogens
  • once bound, antibodies neutralize the pathogen directly of attack other parts of the immune system to eliminate the pathogen
18
Q

What are antibodies made up of?

A
  • y shaped proteins
  • variable region: recognizes and binds the antigen
  • constant region: determines the mechanism used to destroy the antigen
19
Q

What are polyclonal antibodies?

A

complex mixture of antibodies produced by many different antibody-producing cells (each part binds to different areas on the antigen)

20
Q

What are monoclonal antibodies?

A

identical antibodies derived from a single antibody-producing cell (binds to a specific site) (produced in a lab)

21
Q

How are monoclonal antibodies produced?

A
  • target antigen injected into a mouse to start the production of antibodies
  • collection of antibody-producing cells from the mouse, fuse with immortal cancer cells (creating a hybridoma capable of unlimited growth)
  • hybridomas screened for desired antibody production
  • desired antibody-producing hybridoma growth in culture
  • purification of monoclonal antibodies
22
Q

How is recombinant DNA technology used in antibody engineering?

A
  • used to modify mouse monoclonal antibodies, enhancing their resemblance to human antibodies and reducing the risk of adverse immune reactions
23
Q

What are the types of monoclonal antibodies?

A
  • mouse monoclonal antibodies
  • Chimeric monoclonal antibodies (66% human)
  • humanized monoclonal antibodies (90% human)
  • human monoclonal antibodies (100% human)
24
Q

Who is impacted by snake bites?

A
  • half: women and children
  • low- and middle-income Africa and Asia
25
Q

What is the traditional treatment for snakebites?

A

antibody-based antivenom therapy (polyclonal)
- from animals (immunize horses and cows to produce antibodies)

26
Q

What are the side effects (and target) of the 3-finger-toxin from snake bites?

A

target: human muscle-type nicotinic acetylcholine receptors at neuromuscular junctions
- paralysis and death by asphyxiation

27
Q

How were trials in mice done with synthetic antibodies to protect mice from snake venom death?

A
  • inject mice with 1 of 3 different kinds of snake venom
  • treat with synthetic antibody or commercial antivenom that had been pre-incubated with venom
  • Saw 2 out of the three successful
28
Q

What happened during the second trial done on mice with synthetic antibodies?

A
  • injected mice with 1 of 2 kinds of snake venom
  • treat with antibody 0, 10 or 20 min after venom (with only synthetic antibody)
  • measure survival up to 24 hours
  • all were successful
29
Q

What is the summary of the synthetic antibodies and snake venom trial?

A
  • showed a single monoclonal antibody can provide broad preclinical protection against 3-finger-toxin venoms, and exhibits superior efficacy compared to commercially available antivenoms
  • they mimic the interaction between the venom toxin and the human nicotinic acetylcholine receptor
30
Q

What are the impacts of the venom trials?

A
  • important first step in the development of a monoclonal antibody therapy (universal antibody)
  • effectively neutralizes the most diverse and toxic components of snake venom
  • potential global impact
31
Q

What are some issues with biologics?

A
  • complexity
  • high specificity
  • selectivity often less than small molecules due to large surface
  • toxicity is greater than small molecules due to selectivity
  • potential for immunotoxicity
  • monoclonal antibodies have long half-life
  • high cost
32
Q

What are some characteristics of a specialty drug?

A
  • high cost (over $750 per month)
  • requires specialized handling, administration and/ or monitoring
  • used to treat complex or rare diseases
  • often a biologic, rather than a traditional small molecule drug
33
Q

What kind of drugs are predicted to dominate future sales and developmental pipelines in 2025?

A

specialty drugs

34
Q

Why are specialty drugs so expensive?

A
  • increased manufacturing costs
  • higher prices for manufacturers to cover development costs and provide return on investments
  • often have small target populations (low volume of sales)
35
Q

What is an example of a specialty drug?

A

Remicade - monoclonal antibody
- autoimmune disease
- administered at a hospital or clinic
- about $28,000 - 30,000 a year

36
Q

What is the mechanism of action for Remicade?

A

autoimmune disease: immune system attacking the body’s tissues (inflammation)
- Tumor necrosis factor-alpha regulates inflammation
- a chimeric monoclonal antibody that targets this tumor regulator
- by inactivating TNF-a, the inflammatory process can be significantly diminished

37
Q

What are biosimilars?

A
  • a biological product that is similar to the innovator, but are not exact duplication
38
Q

Why is it hard to create a biosimilar that is a replica of the innovator biologic?

A
  • biologics are large and complex (complicated to develop and make)
  • manufacturers of the innovator drugs are not required to share their original formulas (secrets)
  • slight changes in the formula could result in structural changes to the product with different side effects
39
Q

What is the difference between generics and biosimilars?

A

generics: considered bioequivalent and interchangeable
biosimilars: only similar not intercchangeable

40
Q

What is the price of biosimilars?

A

-less costly to develop and require less time (less pre-clinical and clinical data is required)
- estimated to be 20-30% less

41
Q

What is the future for biosimilars?

A
  • increased affordability and increased access to biologics
  • an influx once patents and data protection expire

drug final (14 decks)

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