Download CordenPharma: Focusing on Small-Molecule Oncolytics HERMES

phase, Catalent conducted a series of tests
to complex release profiles. This toolkit of
in this area, says Jason Bertola, Director,
to determine the molecule’s physicochemical
technologies addresses complex extend-
Global Highly Potent & Oncology Platform,
properties and its chemical compatibility
ed-release profiles, as well as the growing
CordenPharma International. “Greater un-
with different excipients, the molecule’s
demand in targeted release delivery.
derstanding of cancer progression has led
solubility and its developability classification
Savings in development time are im-
to the development of increasingly targeted
system (DCS), solid-state characterization,
portant. But with regulators making ever-
approaches, which mean not only increased
and stability. At the enhance phase, Catalent
more stringent demands for broader, in-
safety and efficacy for the patients but
evaluated three enabling technologies in
creasingly global clinical trials, working
also increased manufacturing requirements
parallel, based on the data from the “as-
with a company that can offer strategies
and need for containment and engineering
sess” phase. These included lipid-based
and methods to accelerate a product’s
controls,” he says. “For example, antibody
formulation, amorphous solid dispersion,
journey through the trial process to mar-
drug conjugates (ADCs) offer better safety
and particle size engineering. In 12 weeks,
keting authorization and commercial man-
profiles for patients, but manufacturers
Catalent provided prototypes employing
ufacture, is critical, says Mr. Meissonnier.
must be able to produce and handle cyto-
all three technologies for use in an animal
“This holistic view of development to com-
toxic drugs that are significantly more
PK study, and delivered a full report with
mercialization can maximize the time a
potent than their chemotherapeutic prede-
recommendations and all data, which in-
product enjoys patent protection, and re-
cessors.”
cluded two weeks’ stability testing data.
duce how long it takes for it to recoup its
Trio tested all the prototypes in the
development costs.”
half of the total market. For instance,
bioavailability of all prototypes for TML-2
tyrosine kinase inhibitors and poly ADP-ri-
Among these prototypes, micronization
CordenPharma: Focusing on
Small-Molecule Oncolytics
products are also driving the need for oral
most substantial bioavailability enhancement
cause of death and represents the largest
solid dose highly potent manufacturing.
(4 times).
category of new medicines. A range of
Some estimates predict oral oncolytics to
At the early stages of the development
new mechanisms is expected to drive in-
be 25%-30%2 of the market, double the
process, which spans from drug candidate
novation and growth for the CDMOs that
figures from 10 years ago.
selection to Phase 1 clinical studies, Catalent
have the right expertise and capabilities
abling formulation, formulation screening,
Vol 17 No 3
small-molecule targeted therapies. These
Cancer remains the second leading
druggability, preformulation, toxicity en-
April 2017
bose polymerase inhibitors are among the
(particle size engineering) showed the
and fast clinical supplies to Phase 1. When
CordenPharma’s service offering targets the oral formulation development and
offers a continuum of solutions, including
Drug Development & Delivery
small molecules still represent more than
animal study, and the data showed the
was greatly increased, says Dr. Woodrow.
44
Despite significant focus on biologics,
Manufacturing at
CordenPharma
Plankstadt
(Germany).
manufacturing of oncolytics. “Recent investments have expanded our capabilities
to develop and supply clinical trial materials
incorporated, these solutions accompany
and small-scale manufacturing. Engineering
a molecule to proof-of-concept in-man stud-
controls are in place to allow the safe han-
ies. “This continuum leverages differentiated
dling of compounds in development and
enabling technologies, often targeted at
manufacturing,” he says.
addressing complex bioavailability challenges that go way beyond simple exposure
issues, and ensure successful dose escalation
in single ascending dose studies,” says
Mr. Meissonnier.
HERMES PHARMA: Ensuring
Quality Right From the Start
Quality has always been a key priority
At later stages of product development,
for the pharmaceutical industry, however,
Catalent leverages a toolkit of differentiated
over the last year CDMOs like HERMES
technologies to ensure appropriate matching
PHARMA have observed an increased em-