Pharmaceutical Outsourcing Q2 2024 - 30

ROUNDTABLE
State-of-the-art CDMO facilities and streamlined processes will
accelerate formulation development and result in shorter timelines.
The cost-effectiveness of working with a CDMO is particularly
beneficial for sponsors that may lack in-house capabilities for
pediatric formulation development. CDMOs offer sponsors efficient
resource utilization and budget management. CDMOs can provide
great flexibility in demand-based or need-based manufacturing
capacities, which are essential given the variability in patient
populations for pediatric drugs.
Overall, CDMO partners can function as efficient enablers of a
sponsor's commercialization strategies, streamlining the intricate
process of bringing pediatric medications to market efficiently
and effectively.
Kanji: To meet patient needs and regulatory expectations, the
sponsor must consider the full development of a pediatric dosage
form. This starts with defining the TPP and evaluating risks and
challenges, progressing to formulation development and clinical
assessment of the proposed pediatric formulation in adult panels to
optimize and clinically validate dosage forms based on taste and/or
PK attributes, then into pediatric trials. Finally, the identification of
a long-term manufacturing partner for what may be relatively low
volume commercial products must also be considered.
Clearly, there is plenty to think about on this journey! The challenges
present an opportunity for a strategic partnership between the
sponsor company and its service provider. Strong partnerships are
critical to ensure that the next generations of medicine can get to
those in need, faster.
For the sponsor, the expertise of the service provider can make
all the difference in the success of a program. And for the service
provider to truly be a strategic partner, they should not just act as a
vendor that can efficiently and cost-effectively develop a pediatric
formulation but be able to bring expertise forward to help their
client anticipate and prevent challenges in clinical testing and
regulatory milestones to go on to achieve market success.
LaBella: These partnerships can be critical to progressing a
product to market at a rapid pace. Purchasing, installing and
qualifying new equipment to create some of these platforms can
take away significant time to launch a new product. A CDMO with
the capability and experience in developing and commercializing
various technologies will allow a shorter time to market.
What criteria do you consider when
selecting service providers for pediatric
formulation development, and how
do you ensure quality and regulatory
compliance throughout the process?
Shanmugam: Regardless of the product or service type, the
selection of a CDMO involves a meticulous assessment of multiple
key criteria to ensure a successful on-time development and
commercialization within the constraints of budget, timeline,
quality, and regulatory concerns.
When selecting a CDMO for pediatric product development,
sponsors should prioritize potential partners with a demonstrated
expertise in pediatric formulation, who can provide facilities
with state-of-the-art equipment and flexibility in manufacturing
capacities, and who have experience successfully navigating
regulatory requirements.
Reviewing and verifying a CDMO's regulatory track record and
quality management systems, including GMP practices and quality
assurance systems, help ensure reliability and consistency of
pediatric formulations.
References and past pediatric product development project reviews
can offer valuable insights into a CDMO's capabilities and reliability.
But perhaps the most important criteria to look for in a CDMO
partner is a collaborative approach and communication that is both
transparent and frequent. This ensures a reliable and trustworthy
partnership, which is vital for successful pediatric drug development.
Kanji: A CDMO services provider should have experience that goes
across all areas of pediatric drug development, inclusive of the design,
development, optimization, manufacturing, and supply of pediatric
products. Additionally, the availability of integrated services from one
provider can be invaluable when it comes to streamlining pediatric
drug development. Leveraging the same partner that is both capable
and willing to aid in drug substance and drug product development
and manufacturing, even in situations where there are small patient
populations, reduces hand-offs between multiple vendors, improves
knowledge-sharing and tech transfer.
At Quotient Sciences, we operate as both a CDMO and CRO, with
capabilities to integrate the different modules of activity and
support all stages of development, except conducting the pediatric
patient studies themselves. For example, we have built our own
internal pediatric excipients database with safety information
on more than 60 excipients that we have readily available to
reference. We also developed standalone protocols for in-vitro
characterization studies, including food compatibility, dose delivery
from oral syringes, and dose clearance from nasogastric and enteral
feeding tubes. Finally, we've worked in collaboration with flavor
manufacturers to identify and manufacture potential flavors that
are more suitable for pediatric formulations.
LaBella: Understanding a company's history of developing
products of the desired platform, suspensions of example, is crucial.
Quality audits are always suggested before making a final selection
of a CDMO. FDA inspection history is another factor that should be
evaluated prior to making a CDMO selection.
Pharmaceutical Outsourcing | 30 | April/May/June 2024
Pharmaceutical Outsourcing Q2 2024

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