APR Sept/Oct 2023 - 90

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ROUNDTABLE
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While this is particularly the case for small biotechs, large and midsized
pharma can find this form of partnering advantageous by access
to new technologies without having to develop expensive niche
capabilities in-house.
The ongoing trend for molecules to be insoluble continues to pose oral
formulation challenges. Increasing numbers of larger 'small' molecule
drugs such as protein degraders, with molecular weights above 500,
are being developed, too, and these also require innovation to create
bioavailable oral dosages, including the use of amorphous forms.
There is also growing interest in extending oral delivery to biologics
such as proteins and mRNA. It may be possible to improve efficiency
and safety, as well as reduce costs, by delivering biologics in a sitespecific
way, such as by inhaled delivery, which is more patientcentric
than injection or infusion. Dry powder formulation may also
improve shelf stability of biologics at ambient temperature, cutting
costs and increasing availability in places where cold-chain storage
is challenging.
How has the COVID-19 pandemic impacted
drug delivery technology development and
implementation? Have there been any specific
challenges or opportunities arising from
the pandemic that have influenced your
company's strategies?
Pal: Drug delivery technology development was impacted in several
ways by the COVID-19 pandemic. Specifically supply chain and
operational disruptions. The pandemic disrupted global supply
chains, affecting the availability of raw materials and components
necessary for pharmaceutical manufacturing and laboratory testing.
This challenge has led to delays and potential shortages in drug
production. Lockdowns, social distancing measures, and workforce
availability issues impacted the operations of SGS in the same way
as any other CDMO and the pharmaceutical industry overall. Overall
the industry has become more agile to develop new solutions and get
them to market faster as evident by the rapid availability of vaccines
to treat COVID-19.
The pandemic also highlighted the importance of innovation in
pharmaceutical manufacturing. As a CDMO, SGS expanded services
into research and development, which is heavily tied to formulation
and analytical development, as well as drug delivery technologies to
meet the increased demand for services.
SGS took strategic steps to achieve closer collaborations with our
suppliers to ensure supply chain resilience thus exploring more
innovative manufacturing techniques resulting in accelerating
production processes.
Morgen: One of the challenges arising during the pandemic was
that it placed urgency on the industry to develop treatments and
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vaccines for COVID-19 on an accelerated timeline. This, of course, also
represented a real opportunity for the industry. Organizations who
could respond rapidly and effectively could make significant positive
contributions, as long as they could make a step change in both
thinking and workflows. The rapid progress made with COVID-related
treatments and vaccines demonstrated what was possible, and set a
precedent for agile development programmes across modalities for a
range of therapeutic areas and indications.
COVID also forced the adoption of new ways of working and
collaborating in the industry, with a heavy emphasis on remote work
and virtual meetings. Again, those organizations able to adapt to
these new paradigms were able to successfully execute internal or
contract-related development programs effectively. Those new work
models have, to some extent, persisted.
What are the best practices your company
follows in developing and commercializing drug
delivery technologies? How do you ensure that
your solutions meet regulatory standards while
maintaining a focus on patient safety and efficacy?
Pal: Pharmaceutical Contract Development and Manufacturing
Organizations
(CDMOs) play a crucial
role
in developing and
commercializing drug delivery technologies. SGS takes a
collaborative and early involvement approach, where we work
closely with pharmaceutical companies, sharing expertise and
insights to jointly develop innovative drug delivery technologies
that meet specific therapeutic needs. Early-stage involvement allows
us to provide valuable input on formulation, delivery methods,
and regulatory considerations. We tailor our services to the unique
need of each client providing solutions that align with the drug
characteristic and the targeted patient population. We are equipped
to seamlessly transition from small-scale development to large-scale
commercial manufacturing. Dedicated project management with
open and transparent communication with our clients is key to our
success. Our quality team ensure that our process meet necessary
safety, efficacy, and quality standard at every stage of development
and manufacturing with accurate and comprehensive data collection
and documentation.
In summary, SGS effectively helps our clients, overcome complex
drug delivery challenges, while reducing risks and meeting global
regulatory requirements to accelerate products to market.
Jakob Bonde, Director, Regulatory Affairs
Regulatory, Lonza:
We follow the ICH guidance, and the ICH guidance interpretation
and legislations from the major markets, including the US, Canada,
the EU, UK, Switzerland, China, Japan and Brazil. We also make use of
the experience we have gained from questions in multiple customer
applications, and the acceptance of responses. Pharmaceutical
manufacturing quality is an inherent component of any application
for marketing approval, along with the clinical and non-clinical data,
to ensure patient safety and drug product efficacy.
APR Sept/Oct 2023

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