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“We’ve partnered over 900 drugmakers by bringing together three businesses”
This week, SpeakPharma interviews the CEO of Axplora, Sylke Hassel, along with Stephan Haitz, president of its business unit Novasep CDMO. Axplora is a leading and reliable API manufacturing partner to some of the world’s biggest pharma and biotech companies. Hassel and Haitz discuss how the pandemic has transformed the CDMO landscape, the idea behind setting up a scientific advisory board, and the exponential growth being seen in the antibody-drug conjugates space. Excerpts: Can you briefly take us through Axplora’s history and vision? Hassel: Axplora Group was founded in April 2022 by merging global API manufacturers PharmaZell and Farmabios, as well as leading CDMO — Novasep. The vision was to become a reliable partner to the world’s leading pharma and biotech companies. The group continues to promote the three well-known historical brands while repositioning them in their respective markets — Farmabios is for steroids and highly potent products, Novasep CDMO for small molecule APIs and antibody-drug conjugates (ADCs), and PharmaZell for specialty products and generics. By bringing together these three businesses, we are able to serve more customers with a broader technology portfolio over the entire lifecycle of their products. The partnership starts early in their R&D phases, goes through the commercial lifecycle, and even continues when the product becomes a generic. By joining forces, we make a drastic difference in terms of scale, visibility, market presence, and security of supply. We have partnered over 900 leading pharma companies over the last three years to deliver sustainable, technology-advanced API products and services that benefit millions of patients across the world. 🔑 HIGHLIGHTS// founded in 2022: PharmaZell (steroids and high potent) + Farmabios (generics) + CDMO Novasep (small molecules and antibody-drug conjugates) Axplora has recently set up a scientific advisory board (SAB). How will the formation of the SAB further innovation? Hassel: To us, innovation is the engine for future growth. And the launch of our SAB in November 2023 is a step towards furthering innovation. The SAB brings together five industry experts in key areas of API development and manufacturing – flow chemistry, catalysis, electrochemistry, steroids, biotechnology, and ADCs. Our five international experts — Dr. David Cantillo of the University of Queensland, Prof. Alois Fürstner of the Institute für Kohlenforschung, Prof. Kerry Chester from the University of London, Prof. John Woodley from the Technical University of Denmark, and Dr. Michael Reschke from the Technical University of Hanover — aim to support our R&D team of over 140 to meet next-generation challenges. 🔑 HIGHLIGHTS// Scientific Advisory Board (SAB) = Flow Chemistry, Catalysis, Electrochemistry, Steroids, Biotechnology, and antibody-drug conjugates/ Innovation focus How has the business of API process development and manufacturing changed in recent years? What are the main challenges you face? Hassel: The Covid-19 pandemic has transformed the CDMO landscape. The industry reacted in record time. For example, in a matter of months, Novasep CDMO’s Mourenx site was ready to produce the active pharmaceutical ingredient (API) for a Covid anti-viral therapy, thereby preventing hospitalizations and deaths in high-risk patients. After Covid-19, the industry went through a reset, especially as biotech funding reduced. Therefore, CDMO companies had to reinvent themselves and focus on specialized areas such as ADCs, a molecule that Axplora has produced for over 15 years in Le Mans. The CDMO industry is still undergoing significant transformation. The growth of novel therapies, global supply chain uncertainties, and increasingly tough competition are all examples that require us to continuously adapt to market trends. Understanding these transformations is essential to stay at the forefront of the curve and harness our innovation potential. As mentioned previously, our SAB plays a key role in identifying market trends and in providing insight and guidance to our R&D organization to develop and provide innovative offerings. 🔑 HIGHLIGHTS// novel therapies, global supply chain uncertainties, increasingly tough competition/ identifying market trends and providing insight to R&D Can you tell us a bit more about the CDMO business and your vision? Haitz: We manufacture APIs for our pharmaceutical clients to help them create new drugs that ultimately benefit millions of patients. Currently, we supply over 70 drugs to the market. Our objective is to be a reliable partner for our customers once the drug is commercialized, and ensure security of supply to help patients’ lives. Our challenge as a CDMO is to build a pipeline and then to manufacture the products on time with the necessary quality for our customers, so we need our commercial and operations teams working in synergy. We also have robust processes to ensure that we are cost-competitive. However, we constantly need to add new projects to renew our business and to compensate for the product lifecycle decline. Long relationships with customers are key to our success. We are a manufacturing company with developments and technologies that make a difference. We develop robust, efficient, and scalable processes to ensure we can supply the industrial quantities needed for the market. Our customers are highly appreciative of our technical capabilities – we are a leading company in ADCs, Novasep CDMO is a pioneer in chromatography and chiral separation, and we are well-known for handling hazardous chemistry, which we mainly operate in Leverkusen (Germany) and Chasse-sur-Rhône (France). At the end of the day, we use these technologies to provide the best possible customer service. We are fundamentally a service provider. 🔑 HIGHLIGHTS// 70 drugs/ customization/ commercial and operation synergy/ cost competitiveness/ service provider The market for ADCs is increasing at a fast pace. Tell us about your development and manufacturing services for ADCs. Haitz: These innovative, targeted anti-cancer treatments are benefiting thousands of patients around the world. Currently, there has been an exponential growth in the number of ADCs in development. Among our strong network of 10 manufacturing sites, we have a state-of-the-art facility in Le Mans (France) that has over 15 years of experience in the synthesis and purification of ADCs. We are involved in six out of the 14 approved commercial ADC molecules on the market in Le Mans. We also demonstrate agility in responding to evolving product demand for clinical trials, and also help accelerate market launches. We offer both payload and linker production as well as bio-conjugation services. Quality is key for our customers and our services help them deliver cutting-edge drugs for cancer care. Last month, we announced an investment of €8 million (US$ 8.59 million) in our Le Mans site to further expand our capacity for ADC manufacturing. We are a leader in ADC business, and continue to expand it. Our objective is to help our customers bring breakthrough treatments to the market as soon as possible, thereby helping patients worldwide. 🔑 HIGHLIGHTS// anti-cancer treatments/ 10 manufacturing sites/ accelerate market launches/ payload and linker production as well as bioconjugation services/ investment of €8 million in ADCs site

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#SpeakPharma With Axplora
08 Apr 2024
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