This week, SpeakPharma interviews David
Demailly, API Commercial Director at Aspen API and part of the Aspen Pharma
Group, a global specialty and branded pharmaceutical company. Aspen API has
nearly 100 years of experience in developing and manufacturing active
pharmaceutical ingredients (APIs). Demailly discusses Aspen’s expertise, solutions and sustainability
efforts that have led to the success of the company.
Tell us about Aspen’s history, its culture and its manufacturing.
Aspen API is the cooperative force of Aspen Oss in the Netherlands, Fine Chemicals Corporation in South Africa and Aspen API Inc in Sioux City, Iowa,
USA. In 2023, Aspen API will celebrate 100 years of API development and
We are a
driven and collaborative partner in the development, manufacturing and
registration of complex and highly potent active drug ingredients, which
are utilized in the production of finished dosage forms. Through our
global network of customer relationships, Aspen supplies high-quality APIs that
in turn help improve the lives of patients every day.
We have a global
manufacturing network, with facilities in the Netherlands, South Africa and the
USA. We also use a network of partnerships in India and China. This extended
network mitigates the concerns around the security of global supply.
During the Covid pandemic, we remained focused on the needs of our customers and their patients, ensuring continuity of supply of critical APIs to treat Covid, including the expansion of our capacity for those medications. Our workforce of over 1,200 employees is committed to ensuring continuity of supply of our critical products. Aspen API provides our customers with the highest quality products and brings the most effective solution to each customer. To achieve that goal, we take initiative, we work as a collaborative team, and we innovate.
What makes Aspen API’s portfolio special?
Commitment to quality, safety, innovation, security of supply,
compliance and sustainability is in our organizational DNA. Thanks to our
people, we are able to offer
more than just APIs to our customers.
Our strong portfolio includes 65 high-quality
APIs across a broad range of therapeutics and chemical process categories, such
as high-potency APIs, peptides, oncology APIs, narcotics, analgesics, botanical
extraction APIs and biochemical APIs. We have an active new product development
process that utilizes market intelligence, which when coupled with our
technical expertise, is able to establish new API products that meet the
growing needs of the pharmaceutical industry. We are always on the lookout for
new ideas and opportunities.
customers, as well as the international health authorities, including the US
Food and Drug Administration (FDA), the European Directorate for the Quality of Medicines (EDQM), Dutch health authorities
and the Pharmaceuticals and Medical Devices Agency (PMDA), have repeatedly
confirmed that we are a reliable API provider. Each week, we welcome
(virtual) inspection teams to our sites, and take pride in each successful
With 300 active Drug Master Files worldwide,
we comply with the highest global standards and have comprehensive experience
in dealing with regulatory authorities worldwide.
How does Aspen API view the collaboration with its customers?
We strongly believe in the chemistry of
collaboration, at all stages. We work together as partners. Whether the project
involves a new chemical entity or a process for (re-)designing an (intermediate) API, we work from the development phase to the commercial implementation stage. Fostering
close collaborative relationships with our customers and utilizing our broad
technical expertise and long industry experience, we strive to not only understand our customers’ needs, but also to contribute proactively in discussing more effective, efficient and sustainable solutions to their manufacturing requirements.
Is sustainability important to Aspen API?
Sustainability is a critical building block
for the future at Aspen API. Our aim is to minimize our
carbon footprint and be a leader in sustainable API manufacturing. Wherever
possible, we use green technology and green solvents in our chemical processes.
We provide a safe and healthy workplace for
our employees, and offer fair pay, excellent education and equal opportunities.
While assessing the impact of our environmental,
social and corporate governance, we consider our entire supply chain. We are
actively involved with various organizations, including Ecovadis, the Carbon
Disclosure Project, Ecodesk and the Pharmaceutical Supply Chain
Can you throw some light on your green solutions?
team has developed a patented method for green and large-scale manufacturing of
peptides in a solution called Green Continuous Liquid Phase Peptide Synthesis
(Green Continuous-LPPSTM). This method combines the advantages of
the classical solution-phase synthesis with the solid-phase approach and is
characterized by the fact that intermediates are not isolated. This enables a
highly efficient synthesis method that is easy to scale-up and yields products
of reproducible high purity.
example, we have developed an enzymatic route towards a hormone API, through which
we use 72 percent less water, five percent less solvent and 26 percent less
reactor time compared to the current non-enzymatic and first-generation route.
How is your CDMO contributing towards innovation?
Our development team is committed towards incorporating innovation and green technology into our clients’ projects. Our close connections with educational institutes and innovation companies, such as the Health Valley Netherlands — the biggest Dutch life sciences and health innovation network — enables us to build a strong foundation for sustainable innovation.
What ambition does Aspen API pursue?
Our efforts provide products that make the
lives of people around the world better. It is our duty to develop safe, innovative
and sustainable technologies to strengthen our position in the API business.
How do you adapt to the
changing business environment?
strive to improve our performance. We demonstrated this during the challenging Covid-19
pandemic, when we continued production and even increased our volumes.
Aspen, we have a program to organize our work structurally towards our goal of
sustainable success. We are also working on new innovative technologies to meet
the future needs of the market.
consider the entire supply chain of pharmaceutical products, API is the crucial
beginning and the most critical part of any drug product.
we see a high dependency on countries outside of Europe for key starting materials,
components and building blocks for manufacturing vital drug products. The last
several years have highlighted the vulnerability of critical manufacturing to
supply chain disruptions. The manufacturing of critical APIs in other regions
can increase exposure to manufacturing practices that harm the environment.
challenges and constraints, Aspen API has emerged as a major leader in the
change to transform, rebuild and position API manufacturing as a critical
resource to be managed in an innovative and competitive way.
At Aspen, an API is truly more than just an API.