Abstract

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

Author(s): Allen Loyd V Jr

Issue: Nov/Dec 2022 - Volume 26, Number 6

Page(s): 446-466

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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

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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