Biologics in Medicine
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What is a common method of formulation for biologics?

  • Injectables (IV, SC) (correct)
  • Oral tablets
  • Topical creams
  • Nasal sprays

    • What is a characteristic of large molecules, such as therapeutic proteins, that affects their half-life?

  • They are recycled by the body (correct)
  • They are easily filtered through the kidney
  • They are cleared quickly from the body
  • They require frequent injection

    • What is a characteristic of biologics in terms of storage?

  • They are transported using cold-chain and refrigerated for long-term storage (correct)
  • They are stored at room temperature
  • They are stored in dry conditions
  • They require high temperatures

    • What is the primary function of monoclonal antibodies (mAbs)?

    <p>To target and bind to specific antigens</p> Signup and view all the answers

    Who typically administers biologics?

    <p>Health care practitioners</p> Signup and view all the answers

    What is a common issue with recombinant proteins?

    <p>Aggregation and misfolding</p> Signup and view all the answers

    What is the definition of biologics?

    <p>Active substances made by or derived from a biological source</p> Signup and view all the answers

    What is the typical duration of monoclonal antibodies in the serum?

    <p>14-28 days</p> Signup and view all the answers

    What is an example of a monoclonal antibody-based therapeutic?

    <p>Antibody-drug conjugates</p> Signup and view all the answers

    Why is it difficult to develop biologics?

    <p>Manufacturing and post-translational modifications</p> Signup and view all the answers

    What is an example of a therapeutic signalling molecule?

    <p>Peptide and protein hormones</p> Signup and view all the answers

    What is the definition of a biosimilar?

    <p>A biological product that is highly similar to and has no clinically meaningful differences from an approved reference product</p> Signup and view all the answers

    What is a potential side effect of monoclonal antibodies?

    <p>Reactions to non-human proteins</p> Signup and view all the answers

    What is an example of a blood-related product?

    <p>Recombinant coagulation factors</p> Signup and view all the answers

    How do monoclonal antibodies bind to antigens?

    <p>Through binding to the loops at the tips of the antibody</p> Signup and view all the answers

    What is the result of monoclonal antibodies binding to cell-surface receptors?

    <p>Loss of the cell from the surface</p> Signup and view all the answers

    What is the primary goal of characterizing the structure and function of a reference and proposed biosimilar product?

    <p>To show that the biosimilar is highly similar to the reference product</p> Signup and view all the answers

    What is an acceptable difference between a reference product and a proposed biosimilar product?

    <p>Minor differences in clinically inactive components</p> Signup and view all the answers

    What is the key characteristic of a biosimilar in terms of purity, safety, and potency?

    <p>No clinically meaningful differences</p> Signup and view all the answers

    What is the function of the Fc domain in antibodies?

    <p>To engage C1q, TRIM21, neutrophils, macrophages and NK cells</p> Signup and view all the answers

    What is the primary advantage of a biobetter over a new class of biologic?

    <p>Lower commercial risk</p> Signup and view all the answers

    What is required for amplifying ADCC?

    <p>High tumor antigen density</p> Signup and view all the answers

    What is the primary difference between interchangeability and switching?

    <p>Exchange of one medicine for another with the same therapeutic intent</p> Signup and view all the answers

    What is a challenge in developing biosimilars?

    <p>Meeting manufacturing complexities</p> Signup and view all the answers

    What is the primary role of the pharmacist in substitution?

    <p>Dispensing one medicine instead of another equivalent medicine</p> Signup and view all the answers

    What is an example of a pharmaceutical mAb?

    <p>Humira (adalimumab)</p> Signup and view all the answers

    What is a key challenge in developing biologics?

    <p>The difficulty in developing biologics is not specified</p> Signup and view all the answers

    What is the purpose of an abbreviated approval pathway for biosimilars?

    <p>To eliminate the need for dose ranging studies</p> Signup and view all the answers

    What is the purpose of ADCs?

    <p>To join a chemotherapy drug or radioactive particle to a mAb</p> Signup and view all the answers

    What is an example of a radio-conjugated antibody?

    <p>Tositumomab</p> Signup and view all the answers

    What is the characteristic of bispecific mAbs?

    <p>They bind to two targets simultaneously</p> Signup and view all the answers

    What is the target of the approved bispecific mAb blinatumomab?

    <p>CD19 and CD3</p> Signup and view all the answers

    What is the primary function of immune checkpoint inhibitors?

    <p>To block proteins that prevent T cells from killing cancer cells</p> Signup and view all the answers

    What is the purpose of checkpoints in the immune system?

    <p>To prevent the immune system from overreacting</p> Signup and view all the answers

    What is the result of checkpoints not functioning properly?

    <p>Autoimmune disorders</p> Signup and view all the answers

    How do cancer cells evade the immune system?

    <p>By disguising themselves as normal cells</p> Signup and view all the answers

    What is the driving force behind the development of biosimilars?

    <p>Economic pressures from governments and third-party payers</p> Signup and view all the answers

    What is the primary goal of molecularly targeted therapy?

    <p>To target specific processes in diseased cells</p> Signup and view all the answers

    What is the role of pharmacists in the context of rapid changes in science and regulation?

    <p>To facilitate conversations with physicians and patients</p> Signup and view all the answers

    What is the significance of recent scientific advances in molecular biology, chemistry, and genetics?

    <p>They have enabled the development of molecularly targeted therapy</p> Signup and view all the answers

    What is asthma characterized by?

    <p>Both respiratory symptoms and excessive variation in expiratory airflow function</p> Signup and view all the answers

    What is the control system for respiration?

    <p>All of the above along with central neural respiratory generator</p> Signup and view all the answers

    What triggers the process of expiration?

    <p>Relaxation of diaphragm</p> Signup and view all the answers

    What is the significance of knowing asthma trajectories?

    <p>To determine if a child will grow out of their asthma</p> Signup and view all the answers

    What is the result of inspiration?

    <p>Increase in thoracic cavity space and decrease in intra-pleural pressure</p> Signup and view all the answers

    What is a characteristic of asthma?

    <p>It is a chronic obstructive lung disease</p> Signup and view all the answers

    What may be a result of gene-environment interactions in asthma development?

    <p>Asthma development as early as in-utero</p> Signup and view all the answers

    What is the inspiration-expiration cycle important for?

    <p>For gas exchange</p> Signup and view all the answers

    What is a common trigger of asthma attacks?

    <p>House dust mites</p> Signup and view all the answers

    What is the primary driver of inflammation in asthma?

    <p>Eosinophils</p> Signup and view all the answers

    What is an important step in asthma diagnosis?

    <p>All of the above</p> Signup and view all the answers

    What can occur even with the first episode of asthma?

    <p>Lung damage</p> Signup and view all the answers

    Why is controlling asthma important?

    <p>To reduce remodelling of the lung</p> Signup and view all the answers

    What is a risk factor for asthma flare-ups?

    <p>All of the above</p> Signup and view all the answers

    What is a common allergen that can trigger asthma?

    <p>All of the above</p> Signup and view all the answers

    What is the role of immature dendritic cells in asthma pathophysiology?

    <p>Act as antigen presenting cells</p> Signup and view all the answers

    How can a healthcare professional check if a patient is adherent to their prescribed preventers?

    <p>By checking the patient's pharmacy records</p> Signup and view all the answers

    What is an important aspect of asthma management that a healthcare professional should check?

    <p>The patient's level of SABA usage</p> Signup and view all the answers

    What is a key component of asthma first aid that a healthcare professional should discuss with a patient?

    <p>What to do in a serious asthma flare-up</p> Signup and view all the answers

    What is a resource that a healthcare professional can provide to a patient to educate them on asthma management?

    <p>Asthma Australia website</p> Signup and view all the answers

    Why might a healthcare professional provide a patient with Bisolvon Dry Cough Liquid?

    <p>To relieve coughing symptoms</p> Signup and view all the answers

    What is an important aspect of asthma management that a healthcare professional should check for in a patient?

    <p>If the patient has an asthma action plan</p> Signup and view all the answers

    What is the primary goal of asthma treatment in children?

    <p>To relieve symptoms at least twice a month</p> Signup and view all the answers

    What is the recommended initial treatment for most children with asthma?

    <p>Short acting beta agonists (SABAs)</p> Signup and view all the answers

    What is the potential risk of inhaled salbutamol in patients with glaucoma?

    <p>Acute angle-closure crisis</p> Signup and view all the answers

    What is the elimination half-life of salbutamol?

    <p>2.7-5 hours</p> Signup and view all the answers

    What is the recommended dose of salbutamol for children?

    <p>1-2 puffs (100-200 µg) every 4-6 hours</p> Signup and view all the answers

    What is the primary function of reliever medications in asthma treatment?

    <p>To relieve symptoms</p> Signup and view all the answers

    What is the recommended treatment for children with asthma symptoms more than twice a month?

    <p>Add on ICS or montelukast</p> Signup and view all the answers

    What is the precaution for salbutamol use in patients with glaucoma?

    <p>Risk of angle-closure glaucoma</p> Signup and view all the answers

    What is the formulation strength of Terbutaline in a Dry Powder Inhaler (DPI)?

    <p>500 µgs/puE x 120 doses in inhaler</p> Signup and view all the answers

    What is the duration of action of Terbutaline?

    <p>4-5 hours</p> Signup and view all the answers

    What is a precaution to consider when using inhaled salbutamol?

    <p>Risk of angle-closure glaucoma</p> Signup and view all the answers

    What is an advantage of Dry Powder Inhalers (DPIs)?

    <p>They are more environmentally friendly</p> Signup and view all the answers

    What is a key role of pharmacists in dispensing S3 Relievers?

    <p>To educate patients on proper use</p> Signup and view all the answers

    What is a risk associated with using Short-Acting Beta2 Agonists (SABAs) as needed?

    <p>Increased risk of severe flare-ups</p> Signup and view all the answers

    What is the difference between Salbutamol and Terbutaline?

    <p>There is no clinical difference in effect</p> Signup and view all the answers

    Why is the teach-back method important in inhaler use?

    <p>It ensures patients understand the proper inhaler technique</p> Signup and view all the answers

    Study Notes

    Biologics

    • Biologics are active substances made from or derived from a biological source, rather than a chemical source
    • They are typically proteins or proteins containing agents produced using biotechnology and manufactured in cell culture or living organisms
    • Examples of biologic medicines include:
      • Antibodies and antibody-based therapeutics
      • Recombinant therapeutic proteins
      • Therapeutic signaling molecules
      • Blood-related products
      • Biosimilars
      • Somatic cells, gene-based and cellular therapies, and tissues
      • Vaccines

    Characteristics of Biologics

    • Formulated as injectables (IV, SC) and transported using cold-chain and refrigerated for long-term storage
    • Administered by a healthcare practitioner (except for insulin)

    Biosimilars

    • A biological product that is highly similar to an approved reference product with no clinically meaningful differences
    • Extensive characterization of structure and function is required to demonstrate similarity
    • Minor differences in clinically inactive components are acceptable
    • Abbreviated approval pathway is used, e.g., no dose-ranging studies

    Biobetters (Biosuperior)

    • Related to existing biologics by target of action but deliberately improved in manufacturing attributes, disposition, efficacy, and safety
    • Biobetters build on the success of an existing approved biologic but present a lower commercial risk than a new class of biologic

    Interchangeability, Switching, and Substitution

    • Interchangeability: the medical practice of changing one medicine for another to achieve the same clinical effect in a given clinical setting and patient
    • Switching: the decision by a treating physician to exchange one medicine for another with the same therapeutic intent in a given patient
    • Substitution: dispensing one medicine instead of another equivalent/interchangeable medicine by the pharmacist without consulting the prescriber

    Challenges in Developing Biologics

    • Size of biologics: large molecules are recycled by the body, leading to a long half-life, and require fewer injections
    • Structural features of various classes of therapeutic proteins
    • Glycosylation: different types of N-glycans observed in therapeutic proteins
    • Manufacturing and post-translational modifications (PTMs): aggregation, misfolding, oxidation, deamidation, and glycosylation heterogeneity
    • Human pathogen transmission: transmission of pathogens from expression host to human cells

    Therapeutic Monoclonal Antibodies (mAbs)

    • Monoclonal antibodies are targeted therapy agents produced through genetic engineering
    • They bind to antigens, blocking their action or leading to cell damage
    • Half-life: 14-28 days
    • Side effects: reactions to non-human proteins
    • Kill mechanisms: cell damage, ADCC, and CDC

    Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)

    • EPector cells: NK cells, mononuclear phagocytes, neutrophils
    • ADCC can be amplified by high tumor antigen density, high affinity Fc receptors, and NK cell activation strategies
    • High antibody affinity promotes in vitro ADCC

    Engineered mAbs

    • Types of mAbs: IgG1, IgG2, IgG3, and IgG4
    • Biosimilars: many issues need to be satisfied, including manufacturing, IP, and safety issues

    Pharmaceutical mAbs

    • Examples: Humira (adalimumab), Rituxan (Rituximab), Cetuximab, Trastuzumab, and Bevacizumab

    Antibody-Drug Conjugates (ADCs)

    • mAbs joined to a chemotherapy drug or radioactive particle
    • Examples: Radio-conjugated antibodies (Tositumomab, Ibritumomab), Toxin-conjugated antibody (Gemtuzumab ozogamicin)

    Bispecific mAbs

    • Binds to two targets simultaneously, e.g., cancer cell and an immune cell
    • Examples: Blinatumomab (targets CD19 and CD3), Emicizumab (targets clotting factors IXa and X)

    Immune Checkpoint Inhibitors

    • A type of drug that blocks proteins called checkpoints that are made by some types of immune system cells and cancer cells
    • Helps keep immune responses from being too strong and prevents T cells from killing cancer cells

    Asthma Control

    • Check patient's asthma control by assessing symptoms, medication use, and lung function
    • Check if patient has been prescribed preventers and is adherent to medication
    • Check level of SABA usage and patient's technique for using SABA inhaler
    • Check for comorbid conditions (AR, OSA, GORD) and refer if needed
    • Check if patient has an asthma action plan

    Asthma Management

    • Provide Reliver PuEer and demonstrate proper technique
    • Provide Bisolvon Dry Cough Liquid if necessary
    • Educate patient on preventer use and asthma management
    • Raise awareness about serious asthma flare-ups and asthma first aid
    • Suggest keeping a symptom diary for GP visits
    • Provide information on asthma management (Asthma Australia) and record key counseling

    Asthma Trajectories

    • Variable pathways: early onset (atopic), post-puberty resolution/new development, adult onset (late onset asthma)
    • Importance of understanding trajectories to answer patient questions about growing out of asthma

    Respiratory Tract

    • Inspiration: contraction of diaphragm and external intercostal muscles increase thoracic cavity space and decrease intra-pleural pressure
    • Expiration: relaxation of diaphragm and increase in intra-pleural pressure
    • Inspiration-expiration cycle allows for gas exchange

    Respiration Control

    • Managed by CNS respiratory control system
    • Central neural respiratory generator
    • Sensory input system (thoracic neural receptors, peripheral and central medullary chemoreceptors)
    • Muscular effector system

    Asthma Pathogenesis and Pathophysiology

    • Asthma is a chronic obstructive lung disease that can be controlled but not cured
    • Characterized by respiratory symptoms (cough, wheeze, dyspnoea, or chest tightness) and excessive variation in expiratory airflow function
    • Associated with airway inflammation and airway hyper-responsiveness

    Risk Factors for Asthma

    • House dust mites
    • Mould
    • Pets
    • Pollen
    • Cigarette smoke
    • Exercise
    • Smoke
    • Chemicals
    • Stress
    • Emotions
    • Hormonal changes (women)
    • Respiratory infections (common cold = 80% of bad asthma exacerbations)
    • Weather (e.g. thunderstorms)
    • Medications
    • Occupational exposures

    Asthma Pathophysiology

    • Repeated infections/exposures disrupt airway epithelial barrier leading to danger signaling and chemokine secretion
    • Immature dendritic cells (DC) act as antigen-presenting cells (APCs)
    • Allergen-linked APCs stimulate naïve T helper cells to differentiate to Th2 cells
    • Cytokines linked to Th2 cell response drive inflammation (majority of asthma cases) - eosinophils are the main driver

    Counselling on Controlling Asthma

    • Educate patients on controlling asthma to reduce lung remodeling
    • Importance of preventers in asthma management

    Asthma Diagnosis

    • History (family, symptoms, pattern)
    • Physical examination (wheeze)
    • Consideration of other diagnoses
    • Documenting variable airflow limitation (spirometry)

    Assessing Asthma Control

    • Risk factors for asthma flare-ups

    Asthma Treatment Principles

    • Bronchodilators (relievers): SABAs, LABAs, SAMAs/LAMAs
    • Anti-inflammatory agents (preventers): ICS, LTRAs, targeted biologic agents
    • Need for preventers if symptoms occur more than twice a month
    • Most children can be treated with SABA alone or with ICS or montelukast additions
    • No ICS+LABA combination allowed for 1-5 years children

    Reliever Medications - Schedule 3

    • Short-acting beta agonists (SABAs): salbutamol and terbutaline
    • Salbutamol: formulation type, strength, time to action, elimination half-life, dose, precautions, side effects
    • Terbutaline: formulation type, strength, time to action, elimination half-life, dose, precautions, side effects

    Dry Powder Inhalers - Turbuhalers

    • Teach back method: key steps

    Key Roles for Pharmacists

    • Educate patients on proper inhaler use
    • Counsel patients on asthma management and control
    • Monitor patient adherence to medication and asthma control
    • Identify and address SABA use issues

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    Related Documents

    Biologics PDF
    Asthma PDF

    Description

    This quiz covers the basics of biologics, including their definition, production, and examples of biologic medicines such as antibodies and therapeutic proteins. Test your knowledge of biotechnology and pharmaceuticals!

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