A Novel Inexpensive Process for Preparation of Polymeric Microspheres

The technology patented by SpheriTech and described in this application is
not only novel but provides an inexpensive and efficient means for
manufacture of polymeric microspheres.
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The most important objective is to identify a range of polymers and linkage
technologies for the three target markets. Identification of specific protocols
and technical know how is essential for the success of this work. Ultimately
this will lead to large scale production of specialist polymeric microspheres for
each chosen market sector.
In biocatalysis the worldwide market for the competing technology is
measured in the region of $25 billion (Biocombinatorial Approaches for Drug
Finding, Springer Berlin Heidelberg. ISBN 978-3-540-22092-3). $50 billion of
the $800 billion global commodity, specialty, and fine chemicals markets are
readily addressable by bioprocesses. Another $200 billion has been identified
as potentially addressable by biological app~oaches in the next 1 0 to 20 years
(Chemical & Engineering News, Volume 79, Number 21).
Peptide based drugs are already a major section of the pharmaceutical
portfolio. Sales of the top ten peptide based drugs total over $2000m
annually and the top five of these are in the late stages of patent protection.
The highest value market sector in peptides is in the area of prostate cancer
therapy and since these were developed almost concurrently by major
pharmaceutical companies they are all nearing the end of their patent life.
Leuprolide (Bayer AG, Sanofi-Aventis and others) came off patent in 2005
and already there are 5-6 generic drug manufacturers showing interest. Dr
Don Wellings, the founder and CEO of SpheriTech has consulted on the
synthesis of Leuprolide for three individual companies that cannot be named
for reasons of confidentiality.
Affinity chromatography, used in the purification of biopharmaceuticals is the
highest contributor to the cost of manufacture. lmmobilised Protein A (a
natural protein capable of binding to various classes of immunoglobulin [lg]
molecules, excreted by various bacterial strains) for example is used for the
purification of monoclonal antibodies. The market size for Protein A media in
2007 was estimated to be $49 million and the market size in 2013 is
estimated to be $70 million based on an average annual growth rate of 6% in
antibody production.
More detailed market research is covered in Part C of this application.
SpheriTech plans to obtain a significant market share within each market
sector in 3-4 years.