Term
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Definition
-products that replicate natural substances such as hormones, enzymes, and antibodies in our bodies
-sugars, proteins, nucleic acids or combo
-living entities (cells, tissues, blood, blood products)
-made from variety of natural resources (human, animal and microorganisms) |
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Term
| center for biologics evaluation and research |
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Definition
-within FDA
-regulates a wide range of biological products including
-allergic extracts (ex. for allergy shots and tests)
-blood and blood components
-gene therapy products
-devices and test kits
-human tissue and cellular products used in transplantation
-vaccines |
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Term
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Definition
-first coined in 1919 by Ereky
-a series of enabling technologies involving manipulation of living organisms or their sub cellular components to provide useful products, processes, or services |
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Term
| center for drug evaluation and research |
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Definition
-regulates other categories of biological products mostly produced by biotechnology methods including
-monoclonal antibodies
-cytokines
-growth factors
-enzymes
-immunomodulators |
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Term
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Definition
| designed as targeted therapies in cancer and other diseases |
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Term
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Definition
| types of proteins involved in immune response |
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Term
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Definition
| proteins that affect the growth of a cell |
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Term
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Definition
| -agents that affect immune response |
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Term
| unique properties and challenges |
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Definition
-API
-stability
-delivery
-formulation
-immunogenicity
-pharmacy practice |
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Term
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Definition
-complex molecules (macromolecules)
-primary, secondary, and tertiary structure
-structure function relationship
-produced by biotechnology (ex. rDNA technology)
-heterogeneous
-multiple assays to confirm identity |
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Term
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Definition
-most proteins are not stable in solutions
-chemical/physical instability
-microbial growth
-most products are lyophiles stored at 2-8 deg C
-reconstituted solutions have limited use time |
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Term
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Definition
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Term
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Definition
-denaturation and aggregation due to
-pH and ionic strength
-heat
-multiple freeze/thaw cycles
-removal of water
-agitation/shear
-foaming
-adsorption |
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Term
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Definition
-lyophilization and storage at 2-8 deg C
-cryoprotectants and lyoprotectants
-pH/buffers
-surfactants
-serum albumin
-anti foaming agents |
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Term
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Definition
-biotechnology approaches:
-modify selected amino acid residues
-introduce additional disulfide bonds
-delete non essential portions
-conjugation
-however need to start process over since its a new product |
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Term
| delivery routes of administration |
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Definition
-oral-low and variable bioavailability (GI stability/low absorption)
-parenteral (current standard, SC usually)
-pulmonary-unique applications (Exubera and Pulmozyme) |
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Term
| formulations microbial considerations |
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Definition
-sterility and aseptic techniques
-decontamination and pyrogen removal |
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Term
| parenteral formulation excipients |
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Definition
-solubility enhancers
-anti adsorption and anti aggregation agents
-buffers
-preservatives and antioxidants
-osmotic agents |
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Term
| immunogenicity (provoke immune response) |
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Definition
-structural factors (degree of structual variation, presence of aggregates, glycosylation)
-impurities
-formulation
-route of administration (SC>>>IV) |
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Term
| strategies to reduce immunogenicity |
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Definition
-structural modifications or mutations
-pegylation
-low MW dextrans
-immunosuppressive tx (methotrexate with etaercept) |
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Term
| pharmacists are reluctant to stock due to |
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Definition
-high cost
-special storage and handling reqs
-poor understanding of therapeutics
-reimbursement issues |
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Term
| continuous education and support services |
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Definition
-manufacturer supported resources (professional services, educational materials, reimbursement support)
-professional organizations |
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