Biopharmaceutical Manufacturing

Biopharmaceutical Manufacturing

  • Submitted By: studentlife
  • Date Submitted: 05/08/2013 10:53 AM
  • Category: Science
  • Words: 1202
  • Page: 5
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Biopharmaceutical Manufacturing
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

Microbial contamination
Bacteria Viruses Mycoplasma

Therefore, alternative platforms of production needed:
Plant-made pharmaceuticals

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
Upstream Processing
Produced from microbial cells Recombinant E. coli or yeast cultures Mammalian cell lines Plant cell cultures Insect cell lines In bioreactors of various configurations

Downstream Processing
Removal of insolubles Product Isolation Product Purification Product Polishing

Upstream Processing

Upstream Processing
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...

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