Pharmaceutical Outsourcing Q2 2024 - 25

INTERVIEW
We have recently revamped our high potency suite to provide
containment to > 0.1 μg/m3
. Flamma USA can deliver materials in the
100s of g to the 10s of kilos thus filling two very strategic customer
needs- quick development and scale up. After making a demo batch,
we can prepare the necessary cGMP batch or, if necessary, seamlessly
transfer this to larger scale manufacturing in Italy. We also develop and
manufacture small-niche commercial APIs for small pharma companies
that often have difficulty finding the required manufacturing capacity.
What has been the impact of the pandemic
on CDMOs, and specifically, how did
Flamma navigate through the challenges
brought about by the pandemic?
We navigated the pandemic like the rest of the world. Regardless what
companies say, nobody had any long-term plans in place. That said,
Flamma had a strong will to continue to do our job and to supply
the market with the critical lifesaving therapies that we support. Our
sites faced the same problems that the entire CDMO industry faced
including raw materials shortages, disruption of solvent deliveries
and waste pickup, delayed shipments to customers, quarantined
employees and other experiences. Some of these challenges still persist
today. For example, think about the impact of the great resignation on
the workforce yet the majority of issues have stabilized and we have
found a new equilibrium.
On the supply side, the pandemic highlighted the vulnerabilities of
relying on any one region for essential raw materials and APIs. Despite
this, our Chinese site, Flamma Honkai, was able to manufacture with
little interruption. Flamma made the decision to increase our capacity
by purchasing a large scale European manufacturing site in order to
strengthen our own supply chain. With this rational we acquired the
Bulciago site. This site is about 40 minutes from our headquarters
and is close to Lake Como. We now manufacture APIs along with
intermediates for internal use as well as for customers wanting to file
a second manufacturing site in the West. Similarly, for our Malvern
site, many US based companies can now develop early phase projects
close to home. This strategy has proven to be extremely successful with
many customers.
Ultimately, I believe the pandemic brought a much needed push to
rethink our model. We have not only strengthened our entire business
model but also our organization.
How does Flamma determine the right
mix of services to offer based on the needs
of their clients, and what is your overall
strategy in this regard?
Flamma is a very pro-active CDMO. We not only work with our
customers but we listen to what they say. Being family run and owned
allows us to make decisions much faster than many of our competitors.
We are constantly upgrading out facilities with new equipment and
technology that has helped bring necessary drugs to market.
One example was the installation of our inverted basket centrifuge. This
equipment was critical in solving an issue our customer was having
with their other vendor. We were able to decrease the cycle time and
provide the material to the customer in order to get to the marketplace
sooner. The addition of upgraded reactors and filter dryers continues
across the company.
Meanwhile, we have begun to increase our flow chemistry capabilities
which helps us to be more green and sustainable. It also allows us to
find ways to look at difficult reactions and find a process that solves a
variety of issues.
Our long history with amino acid and peptide chemistry is well known
across the industry. We have decided to use this expertise and look to
provide amidites for oligonucleotide projects. Flamma has developed
a wide range of phosphoramidites to aid in early-stage development
through commercialization. Using a high quality GMP approach that
includes DoE studies, we have been able to provide high quality
phosphoramidites to the industry. These are few examples of how
Flamma continues to evolve.
Considering the evolving landscape of
CDMOs, how does Flamma envision its
growth and positioning in the industry
moving forward?
The vision for Flamma is to continue to grow as a preferred supplier
of commercial APIs and intermediates for innovator companies. In
2025, we will open our second Chinese site at Flamma Honkai. This will
double our capacity to 400 m3
and will allow for growth to ultimately
600 m3
. This will be leveraged with the Italian sites which have 900
m3 of capacity thus providing the industry with the knowledge that
Flamma can secure your supply chain.
We can internally backup our site in China thus taking the risk out of
working there. Flamma's value proposition is far different from our
competitors since we have multiple sites in different geographical
locations all working under the same quality system with a hands on
management style that has proven to be effective.
As Flamma USA continues to become recognized as an option for
early-stage development, it can also provide an easy entry into the
entire Flamma Group. We are proud to be family owned and run since
1950 and do not intend to rest. We hope to have over 1,000 employees
in the next two years but promise to be intimately involved with our
customer's projects. We are fortunate to have many customers be part
of the Flamma family and will continue to stay true to who we are- a
quality CDMO that works with our customers to provide results.
pharmoutsourcing.com | 25 | April/May/June 2024
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Pharmaceutical Outsourcing Q2 2024

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