Abstract
Introduction
Monoclonal antibodies (MAbs) have become the most successful platform for
targeted biotherapeutics, demonstrating high affi nity and specifi city for
their target and considerably lower toxicity than small-molecule drugs.
Technological advances in the development and production of MAbs have revealed
that antibody fragments and other smaller, less complex proteins have the
potential to overcome many disadvantages of MAbs, and researchers have begun
to explore the therapeutic potential of peptides and nucleic acids as
alternatives to MAbs. The small biotechnology companies that sprang up to
commercialize these emerging technologies have benefi ted from a fl urry of
recent licensing and development deals and acquisitions as Big Pharma begins
to see the potential of MAb alternatives and hurries to get in on the action.
Get the Answers You Need to Shape Your Strategy
- The biotechnology and pharmaceutical industries are turning to MAb
alternatives as the next generation of targeted biotherapeutics. What
advantages do small MAb alternatives offer over large MAbs? What disadvantages
do these novel agents have? What choices are possible in the manufacture and
formulation of MAb alternatives?
- Because of the high price of biotherapeutic agents, health care payers,
government, and patients are exerting pressure on companies to lower the
prices of their drugs. How could MAb alternatives help companies respond to
this pressure and remain profi table? How fast and cost-effectively can these
agents be brought to market?
- Although some MAb alternatives are already on the market, and despite
growing industry confi dence in these novel technologies, the road ahead will
not be easy. Why is small size not always better? What clinical
disadvantages may be inherent in MAb alternatives? How will the anticipated
regulatory guidance on approval of biogenerics in the United States affect the
market for MAb alternatives?
Scope
- Biotechnology overview: Biotherapeutics; monoclonal antibodies
(MAbs); emerging MAb alternatives.
- Industry overview: Biotech and Big Pharma companies; marketed MAb
alternatives; molecules in development, by therapeutic area; industry deals
and acquisitions, 2000-2007.
- Production of MAb alternatives: Biological processes versus
cell-free or chemical synthesis; formulation; reducing immunogenicity; cost;
developmental timelines.
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