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Radiolabelling
Custom C-14 radiolabelling companies
Need help in understanding
The suppliers of custom C-14 radiolabelled com-
pounds have responded to the market for increased
the market for new
quality and demand for GMP concepts radiola-
belled APIs. The following section provides some
screening technologies?
selected examples of how key suppliers have
invested to meet this demand:
Selcia has grown dramatically since it began life as
an internal isotope laboratory within May &
Baker (Rhone-Poulenc). This radiolabelling group
was part of a spin out from Aventis in 2001 and,
following a management buyout in late 2005,
Selcia has invested heavily in expanding its custom
carbon-14 radiolabelling business with the result
that it has grown to be one of the leading inde-
pendent custom-14 radiolabelling groups. It
recently announced the opening of a new
radiosynthesis laboratory (Figure 4) in 2009
bringing its capacity to 29 radiochemists. Selcia
specialises in preparing radiolabelled API in accor-
dance with GMP concepts and supplies material
to clinical Phase I units in Europe and the US
which perform the final IMP production and QP
release just prior to human administration. Selcia’s
analytical laboratory is GLP accredited by the
MHRA and offers GLP NMR and GLP certifica-
tion of its C-14 products and GLP certification of
unlabelled material. One advantage of being an
independent C-14 supplier is that clients are able
to choose from the widest number of CROs and
clinical Phase I units the most appropriate special-
ist for their study.
Quotient provided the main news in 2009 when
it announced it would be acquiring the former
Amersham custom carbon-14 radiolabelling
business from GE Healthcare. Amersham had
been the leading supplier of custom carbon-14
HTStec is an independent market research consultancy, focused on
compounds with a long history going back
providing informed opinion and market research on the technologies
more than 50 years. Quotient announced it
that underpin drug screening today. HTStec offers companies that are
would be building a new facility to house this
developing novel liquid handling, detection instruments, laboratory
business at a cost of £15 million within 10km of automation, assay reagents and platform technologies a range of
the old Cardiff facility. Quotient also plans to consulting services and published market reports.
retain its existing radiolabelling group (previ-
ously known as Biodynamics) in
To find out how HTStec can help you maximize the market potential of
Northamptonshire. Biodynamics was one of the
your developments visit...
first custom radiolabelling companies to be
licensed to manufacture radiolabelled IMPs and
has its own QP to perform release to the clini-
cal lab. Quotient is now focusing on offering
clients an integrated service. As well as radiola-
belling it can perform Phase I clinical tests and
perform non-AMS C-14 bioanalysis, albeit not
at a single location.
www.htstec.com
Drug Discovery World Winter 2009/10
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