title: The state of biopharmaceutical manufacturing.
abstract: The manufacturing of protein-based biopharmaceuticals is done in bacterial or mammalian cell cultures. While bacterial cultures are inexpensive, dependable, and approved by regulatory authorities, many complex proteins cannot be manufactured this way. Complex proteins must be manufactured in mammalian cell cultures to produce active products. Mammalian cell culture capacity is limited and has slowed the delivery of necessary biopharmaceutical products to patients. The nature of the production capacity problem and future outlook are critically examined.
authors.affiliation: Biotechnology Equity Research, J P Morgan Chase, New York, NY, USA.
authors.forename: David T
authors.initials: DT
authors.lastname: Molowa
authors.forename: Rosemary
authors.initials: R
authors.lastname: Mazanet
mesh_terms: D001702:Biopharmaceutics / Q000379:methods* / Q000458:organization & administration* / Q000639:trends; D019149:Bioreactors / Q000191:economics* / Q000600:supply & distribution; D001709:Biotechnology / Q000191:economics / Q000379:methods / Q000639:trends; D018929:Cell Culture Techniques / Q000191:economics / Q000379:methods / Q000639:trends; D003132:Commerce; D004345:Drug Industry / Q000379:methods* / Q000458:organization & administration / Q000639:trends*; D015202:Protein Engineering / Q000191:economics* / Q000379:methods* / Q000639:trends; D011994:Recombinant Proteins / Q000096:biosynthesis / Q000191:economics; D013673:Technology Assessment, Biomedical; D014481:United States
chemical_list: D011994:Recombinant Proteins