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OUTSOURCING
Asia grows drug discovery footprint
Outsourcing drug discovery processes such as medicinal chemistry, ADMET (absorption, distribution, metabolism, excretion and toxicology) testing, and high-throughput screening is nothing new. Large pharmaceutical companies have been using a variety of types of contract drug discovery providers since the mid to late 1990s. However, in the past four years the industry has dramatically accelerated the practice, and several large multi-year deals have flung the issue of outsourcing drug discovery back into the newspapers. Scrip Business Insights forecasts the market to grow at a CAGR of 16% from $10.1bn in 2011 to $18.5bn in 2015.
Several recent deals illustrate how big pharma companies are engaging more often and more strategically with drug discovery outsourcing providers. Lilly, which is one of the most active outsourcers in the industry, signed a 10-year $1.6bn deal with Covance in 2008. Under the deal, Covance is providing non-GLP toxicology, in vivo pharmacology, a quality-control laboratory and imaging services. Covance acquired the 450 acre Greenfield Indiana site, taking on 260 Lilly employees. In late 2010, Covance completed a 40,000 sq ft laboratory capacity expansion on the site, which will support its work with Lilly.
The all-seeing eye
While sponsors have always been responsible for the quality of their vendors’ work, it is now clear that sponsors also are being held directly accountable for that quality. Nowhere is this more evident than in the case of recent US Food and Drug Administration warning letters issued to top-quality pharmaceutical firms for failure to oversee the activities of their vendors, specifically but not limited to, clinical trial monitoring.
Problems do not have to reach warning letter status to attract the attention of regulatory authorities. Several sponsors have reported that FDA investigators are specifically asking how the sponsor oversees the activities and assures the quality of its clinical vendors. This is a legitimate question and one that industry sources expect will gain more currency as part of the inspectional process. Third-party quality oversight answers this question.
Made to manufacture
CordenPharma is a specialised contract manufacturer utilising
sophisticated technologies developed through years of proven experience
that are ideal for the production of oral and injectable pharmaceutical
products and their active ingredients.
The company offers customised service packages which span the
entire pharmaceutical product continuum from the development and
manufacturing of Active Pharmaceuticals Ingredients (API), ssistance with approval procedures, formulation, and commercial production of drug
products, all the way to complete pharmaceutical logistics.
Company Background
International Chemical Investors Group (ICIG) is a privately owned
industrial holding company focusing on mid-sized chemicals and
pharmaceutical businesses. Since inception in 2004, ICIG has acquired
17 independent chemical and pharmaceutical businesses with total sales
of approximately €700 million.
CordenPharma, the pharmaceutical brand and platform for ICIG,
was formed out of the scientific, operational, R&D and sales experience
already existing in acquisitions of non-core facilities from well-known
pharmaceutical and biotechnology companies such as AstraZeneca,
Bristol-Myers Squibb, Solvay, Genzyme, and Roche among others. This
model provides customers with global access to a combined legacy of
excellence comprised of each facility’s respective areas of expertise.
Core Offering
As a focused contract manufacturer for pharmaceutical products
and active ingredients, CordenPharma is a full service-provider of
customised service packages in the development and
manufacturing of niche segments such as APIs, final drug product
and generic dossiers.
API Development
CordenPharma’s chemical development scientists have the skill and
experience to meet a wide range of outsourcing needs from route
scouting, process development, scale-up, and optimisation to custom
synthesis in vessels ranging from 10 litres to 2000 litres.
API Manufacturing
CordenPharma’s facilities provide reliable, cost effective world-class
custom pharmaceutical manufacturing capabilities. It conducts commercial
cGMP manufacturing of active pharmaceutical ingredients (APIs) including
peptides, carbohydrates, derivatised lipids and small molecules suitable for
clinical trial supplies and commercial products.
It has an extensive track record in developing, commercialising and
manufacturing multi-step syntheses with more than 30 synthetic steps
(e.g. peptide and carbohydrate chemistry). Its regulatory experience in FDA
inspections brings additional value to the full spectrum of cGMP synthesis
and chemical manufacturing services, from production of early stage
clinical trial materials to product launch and commercialisation.
Here, it draws upon specialised technologies such as the production of
high potency APIs (with ranges down to ng exposure) and peptides from
small scale to metric tonne. Specialised equipment allows CordenPharma
to carry out low temperature work below -100°C at 8000 litre as well as
high pressure catalytic hydrogenation at 70 bars.
Drug Product Development
CordenPharma’s pharmaceutical development begins with identifying
appropriate formulation and analysis, followed by necessary stability
studies, validation methods and processes. Clinical test samples and their
packaging / blinding are included in clinical trial preparations, as are scaleup
and transfer of development projects.
CordenPharma provides development for solid-dosage forms with highly
potent substances such as hormones, cytostatics, and ß-lactams, as well
as sterile forms such as solutions and emulsions.
Drug Product Manufacturing
CordenPharma’s facilities are equipped to manufacture solid dose and
parenteral formulations of cytotoxics, cephalosporines and penicillins,
hormones or hormone blockers. The company offers sterile powder-filled
vials (lyophilised), oral suspension powders, and injectable liquids as well
as specific techniques such as sterile emulsion technology and pre-filled
syringes. Special solid-dose formulations like two-layer tablets, filling of
capsules with powder granules and microtablets are also manufactured for
its customers.
Generic API Manufacturing
For generic drug companies, CordenPharma supplies more than 20 APIs
in a variety of therapeutic areas like pain management, cardiovascular,
gastrointestinal, central nervous system, and respiratory indications.
CordenPharma works with these drug companies well in advance of drug
patent expiration, providing non-infringing processes and filing Drug Master
Files (DMF) or Certificates of European Pharmacopoeia (CEP) for the APIs.
Unique Service Ofering
Within its core offerings, spanning from API formulation development and
manufacturing to final dosage-form commercial supply, CordenPharma
provides a unique selection of specialised technologies and services:
Clinical supply services
CordenPharma’s clinical trial units operate as independent areas within
the close collaboration of its respective formulation development and
commercial manufacturing facilities and professional teams.
Services include manufacturing, randomisation / blinding, labelling,
packaging, QP-release, storage and worldwide distribution of clinical
trial medication including cytostatics (secondary packaging) and cold
chain management.
Packaging
CordenPharma manages the production of its customers’ packaging
components – from coming up with the layout and producing a printable
copy to procuring the materials – with creativity and precision.
Its high performance and high volume packaging equipment guarantees
efficient production and processing of orders for tablets, capsules and
granules. A multitude of different blister and bottle packing lines and
moisture sensitive products are handled with care.
Regulatory registration
As new regulatory developments arise and products change,
whether because of requirements from registration authorities or
to ensure that medicines are safe, CordenPharma’s registration
services manage all the documentation necessary for its customers
to have control over final submission for registration and successfully
implement change applications.
CordenPharma produces all documents needed to retain registration
in the relevant markets for the drugs already produced by existing
CordenPharma facilities.
Pharma logistics
Modern, highly flexible warehouses and distribution centres at
CordenPharma offer experienced domestic and international export
shipping services – including all customs formalities – both within Europe
and worldwide (over 70 countries served) via road, air and sea.
the core value
CordenPharma believes its core value – a long track record of expertise in
the CMO pharmaceutical industry – enables customers to realise hidden
value. The entire organisation and employees are aligned with this core.
Global gathering
CordenPharma facilities, located across Europe and the US, are audited by relevant approval authorities such as EMEA, FDA, Anvisa, TGA and
the Japanese Authority, allowing customers to distribute products manufactured by CordenPharma in all relevant markets worldwide.
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