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Investing in the Future of
Potent Compounds
Shifting needs in the pharmaceutical market are driving a demand for
the manufacture of highly potent active pharmaceutical ingredients at a
variety of scales. By building a new potent unit that expands our potent
compound production capabilities from small to commercial scale,
Seqens is expanding the scope of our contract manufacturing services.

the full development cycle from R&D through commercialization; we
plan to expand the facility as needed, depending on demand.

Potent Market Growth

Seqens has a long history of providing excellent services in custom
development and contract manufacturing for the biotech and pharma
industries. This additional facility will provide our clients with even
more possibilities to reach the market on time. It is a perfect fit with
our existing R&D and production platforms. Companies facing needs
for high-volume potent active pharmaceuticals can now benefit from
our full range of services, including bench R&D, solid-state chemistry,
biocatalysis, project management and regulatory support.

The growing oncology market and an increasing interest in targeted
therapies is driving global attention to highly potent APIs (HPAPIs).
According to market research firm MarketsandMarkets, the global
HPAPI market will expand at a compound annual growth rate of 8.7%,
from $17.72 billion in 2018 to $26.84 billion by 2023.1

Looking to Go Commercial
Seqens, previously the pharmaceutical synthesis and specialty
ingredients company Novacap, has been involved in the small-scale
production of potent compounds for many years. As an element of
our growth strategy, the company was seeking an opportunity to
construct a potent unit at one of our network sites in Europe and the
United States - in 2018, this plan officially came to fruition.
Seqens was chiefly responsible for manufacturing the clinical
quantities of our client's potent HPAPI drug, which was moving
into phase III. This client wanted to keep their business with us, and
building a potent facility was a clear path to expanding our capacity in
potent manufacturing and better serving our customer. Construction
of our Safebridge level 3 facility, which is located outside Paris, France,
was initiated in Q4 2018 and will be completed by fall 2019. Our
overall expansion investment is anticipated to be ~$30 million.

Safebridge Level 3 Facility
Within the facility, our potent unit was designed with the guidance
of Safebridge Consultants, who are industry experts in potent
manufacturing. The potent unit is designed to maintain a maximum
level of particles in the working environment of 100 ng/m3. This
level will allow for the production of Safebridge category 3 potent
compounds - molecules with occupational exposure limits ranging
from approximately 30 ng/m3 to 10 µg/m3.
The modular unit is specifically designed to be flexible and allow
for future investments as customer needs evolve. Once completed,
the initial capacity will be 10-15 tons per year, depending on the
chemistry involved. A second, smaller train with a capacity of 1-2 tons/
year will fill the gap between our existing R&D capabilities and the
larger train. As a result, Seqens will be able to support projects across
Pharmaceutical Outsourcing |

New Capabilities for our Custom
Development and Manufacturing Services

At Seqens, we understand how to conduct chemistry in a contained
environment. We leverage our years of experience manipulating
many different types of molecules to optimize routes, simplify
processes and make them more scalable.
Corporate values and business ethics should be closely linked
and, when selected wisely and implemented effectively within a
comprehensive risk management framework, often create market
value and differentiation.

Meet Seqens
Seqens, which was formed in December 2018, combines the contract
development and manufacturing operations from our subsidiaries
PCI Synthesis, PCAS, Uetikon and Proteus (biocatalysis). The name
reflects the company's core synthesis activities, combined with the
sequencing of competencies, molecules and technologies to take
science to the next level.
Our assets include 24 manufacturing plants and three R&D centers in
Europe, North America and Asia. Our core expertise is in developing
and producing highly complex molecules using a unique set of skills
and a very broad spectrum of technologies. Particular expertise has
been developed in high-pressure reactions, hydrogenation, Grignard
chemistry and low-temperature technology. With all of these
capabilities, we are an integrated global leader in synthesis of active
pharmaceutical and specialty ingredients.

References
1. High Potency APIs /HPAPI Market worth 26.84 Billion USD by 2023.
MarketsandMarkets. Apr. 2018. Web.
33

| pharmoutsourcing.com


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Seqens eBook

Table of Contents for the Digital Edition of Seqens eBook

Contents
Seqens eBook - 1
Seqens eBook - Contents
Seqens eBook - 3
Seqens eBook - 4
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