PH3_2017 - page 6

Despite growth in the outsourcing activity, both
pharmaceutical and CDMO organizations are pointing
out ongoing challenges in outsourcing relationships.
The top issue continues to be communication and
culture. Olon has invested to create a solid base in
the US with Olon USA Inc. and ORB companies to
overcome any possible communication issue and
assuring fast response to the market.
It is essential for CDMOs to have the depth of
technical expertise, quality, regulatory, track record,
and capacity to support its customers from very
early-stage up to late-stage development to meet the
regulatory CMC filing requirement and commercial
launch plans.
Technology transfer from CRO to CMO organization
could imply a huge risk of losing data and critical
information. Inefficiency may result in a delay
in bringing the drug to the market. There is also
increased costs, due to possible repeat work, and
sometimes re-development of part of the program.
The loss of time, resources and investment in this
journey is unquantifiable.
For the above reasons, it makes sense to select a
CDMO, like Olon Group, that can support integrated
services for Drug Substance from early-stage
development (ORB) to clinical manufacturing and
commercial capability (Olon SpA), while also having
scientific expertise and an excellent quality system.
Looking at the changing chemistry landscape as
new drug molecules are becoming more complex,
particularly as drug developers move into different
areas of biology and chemical biology, Olon is
adapting continually to these evolving requirements
in the area of HPAPI, Recombinant Peptides,
Fermentation and Synthetic Organic Chemistry,
Once upon a time…is the typical starting of a
traditional narration, but for today let’s have our
beginning from the latest news: on June 8
Olon SpA
announced the acquisition of Ricerca Biosciences’
Chemical Division of the contract research (CRO) and
CDMO based in Concord, Ohio, USA.
Olon Ricerca Bioscience (ORB)is a CRO supporting
the development and manufacture of APIs and
performance materials in support clinical supply,
market development and commercial distribution.
Ricerca’s extensive process/synthetic chemistry,
analytical chemistry and Engineering expertise
provides a synergy that excels at first‐time scale‐
ups and subsequent Development of safe, reliable,
robust and cost effective manufacturing processes.
This acquisition strengthens the service offering of
Olon for the pharmaceutical and biotech Industry
and benefits the Olon Ricerca Bioscience customer
base by providing large scale manufacturing
capabilities in Europe with 8 FDA-inspected
manufacturing plants.
Olon has decided to consolidate its presence in the
US, confirming its focus on this market with the
objective to accelerate growth by adding new CDMO
projects and to develop new generic products for the
American market.
Small and mid-sized pharmaceutical companies, which
have limited manufacturing infrastructure, rely on
CDMOs for a range of services, including regulatory
filings, quality assurance, procurement and supply
management support, while larger pharmaceutical
companies are often more likely to seek specialized
services and/or complementary capacities, either ways
time to respond is a must-to-have quality and vicinity
to customers is a strategic added value.
Not just a telling story...
focus on Pharma Packaging and Excipients
vol. 1(3) 2017
1,2,3,4,5 7,8,9,10,11,12,13,14,15,16,...68
Powered by FlippingBook