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Compounding with Biotechnology Products, Part 2: Product-specific Considerations

Author(s):  Allen Loyd V Jr

Issue:  Nov/Dec 2022 - Volume 26, Number 6
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Abstract:  Biotechnology drugs involve any technique that uses living organisms in their production or modification. These biotechnology drugs are prepared using different techniques such as recombinant DNA technology monoclonal antibody technologies along with tissue cultures living cells and cell enzymes to make specific products. These new pharmaceuticals are utilized in the diagnosis treatment and prevention of disease, but, because of the risk of clinically important and unusual and potentially harmful adverse effects produced, these agents require increased safety surveillance, and it is very important for pharmacists to participate in any adverse event reporting and monitoring program for these new products. The first biotechnology pharmaceuticals are proteins, but, eventually, an ever-increasing number of smaller molecules may be discovered through the previously mentioned methods and may become a mainstay in new pharmaceutical research and development in producing new drug products. Pharmacists involved in compounding must be aware of not only the biotechnology agent itself but especially of all of the different excipients that are required in order to produce a stable and safe preparation for patient use. Compounding involving these formulations should involve the simplest procedures and formulations as possible, maintaining sterility throughout the entire process. It is important to maintain a drug’s biologic activity up to the point of administration to the patient, and the pharmacist can assist in explaining the various factors involved in storage preparation and administration of the drugs to the patient. In the first part of this two-part series of articles, we discussed the general considerations involved in compounding with biotechnology products. In this final part of the series, we discuss the formulations for a number of commercially available biotechnology products, the purpose of each of the ingredients, and any uniqueness about their formulations.

Related Keywords: Loyd V, Allen, Jr., PhD, RPh, specialty biotechnology products, recombinant DNA technology, monoclonal antibody technology, proteins, polypeptide molecules, peptide technology, formulation composition, stabilizers, excipients, chelating agents, antioxidants, preservatives, polyols, tonicity-adjusting agents, parenteral administration, compounded sterile preparations, biologic activity, filters, sorption, albumin, solubility, chemical instability, physicochemical factors, agitation, quality control, diluents, antisense agents, clotting factors, hematopoietic factors, hormones, interferons, interleukins, HIV, human immunodeficiency virus, lepirudin, anticoagulant agents, fomivirsen sodium, efavirenz, antihemophilic factors, recombinant factor VIII, colony-stimulating factors, granulocyte colony-stimulating factor, filgrastim, pegfilgrastim, monomethoxypolyethylene glycol, PEG, pegylation, sargramostim, granulocyte-macrophage colony-stimulating factor, hemophilia, bleeding disorders, clotting disorders, autologous bone marrow transplantation, erythropoietin, epoetin alfa, hematopoietin, haematopoietin, darbepoietin alfa, drotrecogin alfa, fusion inhibitors, enfuvirtide, growth factors, becaplermin, human growth hormone, hGH, somatotropin, interferon beta-1a, interferon beta-1b, cytokines, aldesleukin, oprelvekin, monoclonal antibodies, anakinra, immunosuppressants, adalimumab, basiliximab, bevacizumab, daclizumab, gemtuzumab ozogamicin, ibritumomab tiuxetan, infliximab, muromonab-CD3, omalizumab, palivizumab, rituximab, satumomab pendetide, tissue plasminogen activators, tocilizumab, trastuzumab, recombinant alteplase, recombinant reteplase, recombinant tenecteplase, vaccines, haemophilus B conjugate vaccine, rasburicase, patient information, patient education, self administration, commercial formulations, storage and handling requirements


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