Deanna Scott, B.S., RAC MIP 480 Lab Basics for the Biotech Industry
What are biopharmaceuticals?
Medical drugs Produced using biotechnology Such as:
Proteins (including antibodies) Nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes
AND are produced by means other than direct extraction from a native (non-engineered) biological source
Biopharmaceutical Manufacturing Concerns
Cost of production
Low volume High purity
Bacteria Viruses Mycoplasma
Therefore, alternative platforms of production needed:
Classification of Biopharmaceuticals
Blood factors (Factor VIII and Factor IX) Thrombolytic agents (tissue plasminogen activator) Hormones (insulin, glucagon, growth hormone, gonadotrophins) Haematopoietic growth factors (Erythropoietin, colony stimulating factors) Interferons (Interferons-α, -β, -γ) Interleukin-based products (Interleukin-2) Vaccines (Hepatitis B surface antigen) Monoclonal antibodies (Various) Additional products (tumour necrosis factor, therapeutic enzymes)
Biopharmaceutical Large Scale Production
Produced from microbial cells Recombinant E. coli or yeast cultures Mammalian cell lines Plant cell cultures Insect cell lines In bioreactors of various configurations
Removal of insolubles Product Isolation Product Purification Product Polishing
Produced from microbial cells
Recombinant E. coli or yeast cultures Mammalian cell lines Plant cell cultures In bioreactors of various configurations
Recombinant DNA Technology
“Genetic engineering” or “Gene Splicing” Involves taking genetic material from one source and recombining it in vitro with genetic material from another source followed by introduction of the recombined material into a host cell.
Advantages of Recombinant DNA Technology
Large scale production Production of...