Download An integrated offering of drug substance and drug product:

PHARMA CONTRACT
SERVICES
Industry perspective - customer's publication
LUKAS UTIGER
DPx Fine Chemicals and Integrated Solution, DPx Holdings B.V., The Netherlands
Lukas Utiger
An integrated offering of drug
substance and drug product:
only a buzz or the next evolution of the CDMO Industry?
KEYWORDS: pharma, integrated offering, Patheon OneSourceTM, CDMO, API, PDS, outsourcing
Abstract
Lukas Utiger, President, DPx Fine Chemicals, DPx Holdings B.V., discusses how the 2014 merger between
Patheon and DSM Pharmaceutical Products continues to create impactful changes in the chemical CMO
world, notably with the manufacturing company’s new integrated supply chain offering, Patheon OneSourceTM.
The pharmaceutical and biopharmaceutical
industries have been outsourcing product
development and manufacturing for
years but the Contract Development and
Manufacturing Organization (CDMO) model
must be optimized to meet increased
customer demands. Decreasing the drug
development cycle time and customer
management responsibilities through
integrated, end-to-end offerings is a large
benefit to small and mid-size pharma
companies.
Shifts in the ownership of early phase
compounds to mid-size and smaller pharma
companies with increased involvement from
external venture capital and private equity
funds leads to more outsourcing of drug
substance, drug product, and analytical and
regulatory services. Captive manufacturing
is only favored by large pharma and generic
companies (Figure 1).
Figure 1. Source PharmaProjects (raw data extracted April 2014) DPx SBI
Pharmaceutical outsourcing continues to increase each
year throughout the value chain. In 2014, outsourcing of API
manufacturing rose by almost 20 percent from the previous
year, while commercial final dosage manufacturing rose 9
percent from 2013 to 2014 (Figure 2).
In recent years, CDMOs have adapted to customer demand
for a more simplified supply chain that drives faster, highquality results. This end-to-end development process has
Chimica Oggi - Chemistry Today - vol. 32(6) November/December 2014
proven to be the next evolution of the industry, rather than
just a brief trend. Patheon was an early adaptor of this
integrated offering when it strategically merged with DSM
Pharmaceutical Products in March 2014 to add scale, value
chain capabilities and technologies, and to expand the endto-end service offerings as an all-inclusive solution provider
to the pharmaceutical industry. Patheon’s capabilities now
include everything from API, product development, and
biologics to drug product services.
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the development process. This service offers
customers a simplified way to move toward
their next clinical milestone, giving them
the opportunity to focus on their strengths,
while Patheon handles management of the
development process through a full service
supply chain. This delivers a robust solution for
emerging and mid-size pharma and biotech
companies, as they gain added value through
consolidated offerings only available from a
large-scale organization with the advanced
manufacturing technologies and expertise.
Figure 2. Source: Contract Pharma 2013 & 2014 Outsourcing Survey
Patheon recently launched the first wave of the Patheon
OneSourceTM offering, an end-to-end development solution
focused on increasing value through simplicity, speed
and quality expertise in drug substance and drug product
development, which means products get to market faster.
The launch of this new offering has focused on the product
life cycle Phase I through Phase II, and the second wave
of Patheon OneSourceTM will focus on Phase III through
commercial stages of development. The offering streamlines
supply chain activities by assigning a program manager to
serve as a single point of contact for overseeing both API
and finished product as well as offering customers a flexible
contracting process that results in a single contract to govern
their business with Patheon. Having this system in place and
a program manager who proactively manages the process
and identifies opportunities to reduce timelines and avoid
risks can save two to four months in time on small or large
molecule development projects (Figure 3). Additionally,
the Patheon OneSourceTM offering provides additional
value to customers by decreasing
approximately eight to 12-weeks
in cycle time, which is a significant
improvement on the industry standard
of a 15-month development cycle.
Patheon OneSourceTM leverages the
years of experience Patheon has
with large and small molecule API
and development of various dosage
forms, enabling customers to become
more productive through Patheon’s
significant size, global operations,
integrated capabilities and capacity,
and state-of-the-art technology.
The development capabilities offered
through Patheon OneSourceTM
range from early clinical Phase I to
commercial-scale production for both
drug substance and drug products,
and are supported by collaborative
teams who provide customers with
industry-leading expertise throughout
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As the leading provider of custom
manufacturing, technologies and
development services to the pharmaceutical
and biopharmaceutical industries, Patheon is
uniquely positioned to deliver quality products
and seamless services that generate superior
returns for customers. With more than 20
years of experience with regulatory strategic
management, Patheon builds the stage for
clinical success through sharing expertise with customers.
Patheon completes more than 250 development projects
each year across all technologies, including more than
200 tech transfers and more than 1000 analytical method
transfers, and continuously collaborates with more than
200 pharma companies regarding technical development,
regulatory strategy, analytical services, quality systems and
supply chain simplification.
The Patheon OneSourceTM offering brings speed, coupled
with in-depth expertise and simplicity to deliver the results
for the customer as quickly as possible. In order to support
patients with the highest quality drugs in the most efficient
manner, the CDMO and pharma industry operational
models must continue to evolve toward integration and
end-to-end offerings that meet customer needs. More
specifically, small and mid-sized pharma companies can
gain great value through integrated offerings such as
Patheon OneSource™.
Figure 3. Project Time for drug substance and drug product development
Chimica Oggi - Chemistry Today - vol. 32(6) November/December 2014