Podcast
Questions and Answers
What is one advantage of recombinant insulin over traditional methods?
What is one advantage of recombinant insulin over traditional methods?
Recombinant insulin is much easier to purify.
How can recombinant proteins like insulin be modified for faster absorption?
How can recombinant proteins like insulin be modified for faster absorption?
Insulin can be modified, such as insulin lispro, to prevent dimerization, allowing for faster absorption.
What is the purpose of creating long-acting insulin analogues like glargine?
What is the purpose of creating long-acting insulin analogues like glargine?
Long-acting insulin analogues like glargine are designed to form aggregates for slower absorption.
What genetic condition primarily affects blood clotting and is linked to Factor VIII or IX mutations?
What genetic condition primarily affects blood clotting and is linked to Factor VIII or IX mutations?
What major concern arose from the purification of clotting factors from human plasma prior to the introduction of recombinant forms?
What major concern arose from the purification of clotting factors from human plasma prior to the introduction of recombinant forms?
Why is screening essential for blood donors providing plasma for therapeutic use?
Why is screening essential for blood donors providing plasma for therapeutic use?
What differentiates fully synthetic vaccines from biologicals?
What differentiates fully synthetic vaccines from biologicals?
In which year did the replacement of clotting factors from human sources with recombinant forms begin?
In which year did the replacement of clotting factors from human sources with recombinant forms begin?
What is the primary therapeutic category of adalimumab and what is its trade name?
What is the primary therapeutic category of adalimumab and what is its trade name?
Explain the role of B lymphocytes in the production of antibodies.
Explain the role of B lymphocytes in the production of antibodies.
Identify the drug associated with the trade name Keytruda and its mechanism of action.
Identify the drug associated with the trade name Keytruda and its mechanism of action.
How do therapeutic antibodies like Rituximab function in cancer treatment?
How do therapeutic antibodies like Rituximab function in cancer treatment?
Which drug ranks fifth in sales in 2021 and what is its therapeutic indication?
Which drug ranks fifth in sales in 2021 and what is its therapeutic indication?
Describe how therapeutics like etanercept mimic or obstruct biological pathways.
Describe how therapeutics like etanercept mimic or obstruct biological pathways.
What is the main purpose of the variable domain of an antibody?
What is the main purpose of the variable domain of an antibody?
What therapeutic action does dulaglutide serve and what class of drug is it?
What therapeutic action does dulaglutide serve and what class of drug is it?
What was the leading drug by sales in 2021 and how much did it generate?
What was the leading drug by sales in 2021 and how much did it generate?
Describe the method of variolation and its historical significance.
Describe the method of variolation and its historical significance.
Which drug ranks second in sales in 2021, and what is its trade name?
Which drug ranks second in sales in 2021, and what is its trade name?
What year did smallpox get eradicated, and what fundamental technique helped achieve this milestone?
What year did smallpox get eradicated, and what fundamental technique helped achieve this milestone?
Identify the drug with the lowest sales in the top 12 drugs listed and its trade name.
Identify the drug with the lowest sales in the top 12 drugs listed and its trade name.
What were the estimated annual deaths from smallpox in 18th century Europe?
What were the estimated annual deaths from smallpox in 18th century Europe?
Mention the combined drug that ranking seventh in 2021 sales and briefly describe its usage.
Mention the combined drug that ranking seventh in 2021 sales and briefly describe its usage.
Name one drug from the list that is primarily an anticoagulant and its sales figure.
Name one drug from the list that is primarily an anticoagulant and its sales figure.
What historical event in 1901 is associated with the first Nobel Prize in Medicine?
What historical event in 1901 is associated with the first Nobel Prize in Medicine?
What is the mechanism of action for recombinant proteins used as drugs?
What is the mechanism of action for recombinant proteins used as drugs?
Who were the scientists that identified insulin and when did this occur?
Who were the scientists that identified insulin and when did this occur?
What type of insulin was used to treat Type I Diabetes Mellitus before the introduction of recombinant insulin?
What type of insulin was used to treat Type I Diabetes Mellitus before the introduction of recombinant insulin?
What major advantage does recombinant insulin have over its animal-derived predecessors?
What major advantage does recombinant insulin have over its animal-derived predecessors?
What contribution did James Gillray’s work in 1802 make to discussions about biologicals?
What contribution did James Gillray’s work in 1802 make to discussions about biologicals?
What role do proteins isolated from tissue play in medical applications?
What role do proteins isolated from tissue play in medical applications?
What are some examples of biologicals mentioned in the content?
What are some examples of biologicals mentioned in the content?
What is one major disadvantage of biologicals compared to small molecules in terms of administration?
What is one major disadvantage of biologicals compared to small molecules in terms of administration?
Why is the production of biologicals considered laborious and costly?
Why is the production of biologicals considered laborious and costly?
Describe one way the efficacy of biologicals can vary among patients.
Describe one way the efficacy of biologicals can vary among patients.
What is the implication of biologicals having a shorter shelf-life?
What is the implication of biologicals having a shorter shelf-life?
How does the half-life of biologicals differ among various types, such as insulin and therapeutic antibodies?
How does the half-life of biologicals differ among various types, such as insulin and therapeutic antibodies?
What is a safety concern associated with biologicals, and how does it differ from traditional pharmaceuticals?
What is a safety concern associated with biologicals, and how does it differ from traditional pharmaceuticals?
Study Notes
Top Selling Drugs of 2021
- Adalimumab (Humira): Highest sales at $20.69 billion.
- Pembrolizumab (Keytruda): Second most sold with $17.18 billion.
- Lenalidomide (Revlimid): Third with $12.82 billion in sales.
- Additional notable drugs include Apixaban (Eliquis) at $10.76 billion and Ustekinumab (Stelara) at $9.13 billion.
- Biktarvy and Rivaroxaban (Xarelto) also ranked high, with sales of $7.81 billion and $7.52 billion, respectively.
Historical Context of Biologicals
- Variolation: Originating in China during the 10th century, involved inserting powdered smallpox scabs to induce immunity.
- Smallpox Eradication: Achieved in 1980, previously caused 400,000 deaths annually in 18th century Europe.
- Early Biologicals: First Nobel Prize in Medicine awarded in 1901 to Emil von Behring for developing diphtheria antitoxin.
Production and Functions of Recombinant Proteins
- Includes therapeutic proteins like insulin, erythropoietin, and blood factors.
- Process utilizes isolated proteins from animal tissues or engineered cells in vitro.
- Acts as substitutes for non-functioning or absent natural proteins in patients.
Insulin Information
- Insulin Discovery: Identified by Banting and Best between 1920-1921; first human treatment occurred in 1922 with ox-pancreas extract.
- Recombinant Insulin: Available since 1982, leading to increased purity and reduced allergenic response.
- Development of insulin analogues such as Lispro (Humalog) for fast action and Glargine (Lantus) for prolonged action.
Treatment of Hemophilia
- Caused by mutations in Factor VIII or IX leading to clotting issues.
- Initial treatments used clotting factors from human plasma, replaced by recombinant forms in 1984 to avoid contamination risks.
Importance of Biologicals
- Are vital in modern medicine for treating various conditions but have unique challenges.
- Difficult to produce at scale, require precise handling and storage to maintain efficacy.
Therapeutic Antibodies
- Produced by B lymphocytes; bind specifically to foreign molecules (antigens).
- Therapeutic antibodies can mimic or block endogenous pathways for treatment.
- Examples include Etanercept and Dulaglutide, which target specific receptors for functional effects.
Challenges of Biologicals
- Large molecular size leads to poor gut absorption – requires injections.
- Production is costly and complex, often with a shorter shelf-life than small molecules.
- Potential for increased immunogenicity and allergic reactions.
Pharmacological Aspects
- Half-Life Variation: Ranges widely from short (insulin) to long (therapeutic antibodies).
- Safety profile includes reduced toxicity but may trigger immune responses due to their complexity.
These notes encapsulate essential facts regarding the top-selling pharmaceuticals, historical developments in biological therapy, their production, and associated challenges.
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