Biopharmaceuticals Flashcards
What are biological therapeutic products (2)
- any protein, virus, vaccine, blood product, or
analogous product used for prevention,
cure, or diagnosis of human disease. - e.g. blood-derived clotting factors, plasma & platelets
What are pharmaceutical biotechnology products (2)
- any therapeutic or diagnostic product produced in full or in part by a biotechnological mean
- e.g. beta-lactams, tetracyclines & macrolides
What are biopharmaceuticals (2)
- a protein or nucleic acid-based therapeutics
and/or diagnostic produced by a genetically
engineered organisms by recombinant DNA
technology. - e.g. monoclonal antibodies, cytokines, oligonucleotides
What are the classes of biopharmaceutics (10)
- Monoclonal antibodies
- Erythropoietin
- Vaccines
- Insulin
- Interferon
- Human growth hormones
- Granulocyte colony-stimulating factor
- Interleukin-based products
- Tumour necrosis factor
- Blood factors
What are the therapeutic areas of biopharmaceutics (6)
- Neurology
- Infectious Diseases
- Diabetes
- Oncology
- Cardiovascular
- and others.
When preparing and dispensing biotechnology products, what is important that the patient understands (6)
- use
- dosage regimen
- potential adverse effects
- proper storage and handling
- administration protocol
- provide training for patients and/or caregivers
CPD (4)
- knowledge of biotechnology tools
- understand the therapeutic aspects of biopharmaceuticals
- understand the side effects and patient counselling info
- familiarity with handling/storing/preparing biopharmaceuticals
What does the understanding of biotechnology tools (principles and applications) mean (4)
- understanding of recombinant DNA technology
- familiarity with protein chemistry
- awareness of drug delivery systems exploited for the administration of
biotech drugs - knowledge of immunology and immune response
How can the awareness of drug delivery systems be exploited for the administration of biotech drugs (4)
- Textbooks
- Manufacturer websites
- GPC
- Regulatory bodies (EMEA)
What are the issues associated with biopharmaceutics (5)
- Chemical nature
- immunogenicity & side effects
- ADME
- Production
- Storage & handling
What are the different levels of structure of biopharmaceuticals (6)
- Biopharmaceuticals = proteins
- Primary
- Secondary
- Tertiary
- Quaternary
- Peptide bonds are present in endogenous proteins and substrates of peptidases.
What is active principle degradation (1)
- careless exposure to uncontrolled
environmental conditions (pH, temperature,
light, oxygen, heavy metal ions, humidity) can
lead to product loss and reduced activity
What are sterility issues (1)
accidental breakage of the packing
material can lead to contamination, a
the big caveat for drugs administered by
parenteral route
How are biopharmaceuticals handled in terms of reconstituting the solutions (3)
- In hospitals or speciality pharmacies, the biopharmaceutical agent is prepared by the pharmacist.
- often, the drug is stored as a freeze-dried powder
- the pharmacist must then reconstitute the solution by dissolving the powder in an appropriate vehicle (saline, deionised water, solution with stabilisers and/or other excipients)
What are the rules for reconstituting the solutions of biopharmaceuticals (4)
- common excipients are anti-caking agents, anti-adherent (proteins), electrolytes (isotonic)
- complete dissolution of the drug (slow addition of the vehicle)
- avoid shaking the solutions (foaming)
reconstitute immediately before the administration - sterility must be ensured during the whole process
How do pharmacokinetics and pharmacodynamics apply to biopharmaceuticals (6)
- General pharmacokinetic and pharmacodynamic principles apply.
- structural similarity to endogenous
- structural/functional compounds
- intimate involvement in physiological processes at a molecular level
- intrinsic difficulty in detection and determination amidst similar species
- large size
How is absorption affected by biopharmaceuticals (2)
- Biopharmaceuticals are generally not active upon oral administration.
- This is due to their instability in the presence of gastrointestinal enzymes and to their scarce permeability through the gastrointestinal mucosa.
How is distribution affected by biopharmaceuticals (2)
- Biopharmaceuticals can bind to endogenous proteins.
- this behaviour decreases the
availability of the biopharmaceutical and increases its half-life
How is metabolism affected by biopharmaceuticals (2)
- Biopharmaceuticals are highly subjected to
proteolysis by endogenous enzymes - the gastric apparatus, the liver and the kidneys are the main sites of proteolytic metabolism
What are the administration routes for biopharmaceutics (4)
- Inhalation - good route, avoids first-pass
metabolism, highly vascularised, fast
access to bloodstream - Oral - with few exceptions, not used
- Transdermal patch - progressively more used as an administration route (e.g., insulin minipumps)
- SC, IM, IV - highly used, guarantees bioavailability, relies on sterile drugs
How do biopharmaceutics affect immunogenicity (1)
therapeutic proteins can be recognised as “non-self” and trigger an immune response with varying clinical consequences
How are biopharmaceuticals produced (3)
- biopharmaceuticals and biotech drugs are
obtained by recombinant DNA technology - technology that allows the genetic modification of organisms
- efficient way to amplify DNA fragments and to access gene products
(proteins, metabolites) from the host of choice
What are the recombinant DNA technique steps (6)
- retrieving the gene of interest
- fusing the gene with a vector
- introducing the vector in a host
- selecting the transgenic hosts
- propagating the gene
- expressing the protein
How are biopharmaceuticals produced via fermentation (7)
- Fermentation
- Cell separation
- Cell breakage
- Concentration (filtration)
- Preliminary purification
- Chromatography
- Product
How are biopharmaceuticals packaged (6)
- Fill-sterile area
- Stopper - sterile area
- Assemble - sterile area.
- Inspect pack - non-sterile area.
- Bulk filling - the sterile drug is placed in large containers (5L – 100L) for shipment or storage purposes.
- Final filling - the sterile drug product is transferred into its final container/closure system. Vials, Ampules, Syringes, Dental Cartridges
What does the choice of packaging material for biopharmaceuticals depend on (2)
- whether the drug is in its final container/system or whether it is packaged in bulk
- whether the drug needs to undergo further processing (freeze-drying)
What are the considerations for glass packaging of biopharmaceuticals (3)
- suitable for freeze-drying
- fragile
- possible leaching of glass components in the solution
What are the considerations for PET packaging of biopharmaceuticals (3)
- unsuitable for freeze-drying
- more easily pierced
- possibility of adsorption of the drug to the surface of the container
