“Our API is a critical resource that’s managed in an innovative, competitive way”

#SpeakPharma with Aspen API

2022-06-13

Impressions: 2931

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 manufacturing.

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.

Our 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 inspection.

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 Initiative.

Can you throw some light on your green solutions?

Our technical 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-LPPS^TM). 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.

In another 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?

We continuously strive to improve our performance. We demonstrated this during the challenging Covid-19 pandemic, when we continued production and even increased our volumes.

Within 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.

When we consider the entire supply chain of pharmaceutical products, API is the crucial beginning and the most critical part of any drug product.

Currently, 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.

Despite these 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.

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