APR Nov/Dec 2022 - 28

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FORMULATION AND DEVELOPMENT
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A CDMO Perspective on Developing Biological
Modalities from Discovery to Commercialization
Jim Huang, PhD and Shaukat Ali, PhD
Ascendia Pharma
Introduction
Biological modalities with poor solubility and bioavailability are
presenting challenges to drug manufacturers to move them from
discovery to manufacturing. Drug sponsors are looking to contract
manufacturers to help them overcome this problem as many offer
tailored and customized approaches to expedite the launch and
commercialization of these drug molecules.1
As the cost of developing
new chemical entities (NCEs) keeps rising, reaching over $2B for a
single molecule and taking over 10 years with fear of a patent cliff,
drug manufacturers are also weighing options for outsourcing
the formulation development to get better return on investment
(ROI).2
Together with the rising cost and risks on development, drug
manufacturers are exploring all avenues to reduce time and cost to
expedite the commercialization and marketing of drug molecules,
while focusing on prioritizing projects and investment on their most
innovative and blockbuster products. This trend is contributing to
a seismic shift in the industry that is fueling potential growth in the
contract drug manufacturing organization (CDMO) industry.3
Weighing Options for a CDMO
As costs continues to rise in development of new molecules,
finding a CDMO partner that " fits for all " with the expectation
of saving time and resources, and meeting project deadlines,
continues to be challenging. For instance, molecules with poor
solubility and bioavailability, weighing options on employing an
appropriate formulation technology and finding a right partner
with technical know-how and expertise, remain an impediment.
For example, developing a drug in liquid or solid oral, and/or in
parenteral form, requires a careful design of experiments (DOEs) for
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CDMO's Capabilities and Relationship
with Clients
Technological challenges stemming from physico-chemical properties
of new molecules coupled with limited resources within the contract
manufacturers, and/or a reliable supply chain, can lead to additional
delays in development and manufacturing of clinical supplies,
initiation of clinical trials, and hence, the approval and marketing
of new drug candidates. Thus, adapting the strategies with a first
tier and second tier approach to CDMOs based on their capabilities
and expertise, should be a prime consideration for building trust
and partnership while aiming to mitigate the timeline and meet the
developmental processing and cost.4
For example, building trust
and a better relationship based on their offerings will lead to further
business potential and expedite the drugs faster to market, and hence,
ultimately lead to multiple business opportunities in the future. With
both the R&D expertise, and cGMP manufacturing capabilities suited
an optimal formulation to meet the critical quality attributes and
the clinical end points to satisfy the FDA's guidelines. This creates
the opportunities for CDMOs with enabling technical capabilities
in developing multiple dosage forms for different modalities with
their proprietary formulation and development capabilities. In
those cases, early phase development, as a feasibility to proof of
concept (POC) followed by evaluation for scale-up, bear risks but is
highly plausible and rewarding with a CDMO partner offering the
right expertise in formulation development, analytical services and
processing capabilities. With continued interest in the development
of biologics, identifying one CDMO from early stage to scale-up and
manufacturing could also require full assessment of their internal
technical, analytical and cGMP manufacturing capabilities.
APR Nov/Dec 2022

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