We are excited to announce the launch of our integrated drug discovery support service program. Over the last 18 months, we have worked very hard to integrate our services. We have set up programs in the fields of chemical-pharmaceutical development, nanomedicine development and clinical supplies. Our most recent achievement has been the incorporation of an integrated service program in the drug discovery arena. On the occasion of this milestone, our Corporate Technology Officer Michiel Van Speybroeck had a conversation with Gerjan Kemperman (COO, Chem-Pharm Services) and Melloney Dröge (Technical Director, BIO Services).
Michiel: “Melloney, most of our customers will know us as a development company that comes into action when compounds are selected for preclinical development. We have been active in the drug discovery field for quite some time though. Can you elaborate on our historical activity in this area?”
Melloney: “We have indeed been offering drug discovery support services for over ten years now, mainly in terms of in vitro pharmacology studies, ADME support (Absorption, Distribution, Metabolism and Elimination, red.) and bioanalysis. Our in vitro pharmacology services range from enzymatic, functional, receptor-binding to cell-based assays. We usually install assays that have previously been developed by the sponsor, but we also develop assay ourselves. The nature of our bioanalytical support in discovery may vary widely. We pride ourselves on being able to quantify almost any therapeutic molecule, small or large, in almost any biological matrix. Our ADME profiling activities comprise a range of in vitro and ex vivo assays, the combined results of which provide key information when deciding on a compound’s developability.”
Gerjan: “Within the new service program, we are involving our own chemistry and preformulation experts in the later stages of discovery support projects. This enables us to provide our customers with a much more holistic view of a compound’s or lead series’ developability. In addition to ADME data, our multidisciplinary teams deliver critical information on synthesis safety and scalability, solid-state properties, chemical stability and solubility. Chemistry and preformulation expertise have been residing in our organisation for decades, and we are excited to now have created an operating structure in which these experts complement our ADME scientists in multidisciplinary teams.”
How will this integrated approach benefit our customers?
Gerjan: “Besides the obvious advantages such as a reduced contracting burden and fewer communication lines, we believe there are many technical advantages associated with an integrated approach to drug discovery support services. For instance, having our experts evaluate the chemistry of late discovery compounds enables us to anticipate potential safety or scalability issues. And in the event of compound selection for development, our chemists can scale up much faster as process knowledge has already been obtained in discovery.”
Melloney: “Similarly, the bioanalytical knowledge that our ADME teams build up during discovery enables much faster method development during the preclinical and clinical stages.
Gerjan: “And there are other benefits of involving our chemists early on. Quite often, late-stage discovery programs require resupply of intermediates or final compound at scales of 10 to 100’s of grams. Medicinal chemistry labs generally lack the capabilities and expertise to produce batches of this size. At Ardena, however, we are very well equipped to produce at this scale with multiple reactors in the 5-50 L range and a broad array of preparative chromatography equipment. Our process chemistry capabilities may therefore be usefully deployed to ensure timely resupply of intermediates or final compound during the later stages of drug discovery programs. And we are obviously more than well equipped to produce subsequent preclinical and clinical drug substance, with multiple reactors in the 100-1000 L scale range.”
And how do you approach project execution in such cross-functional teams?
Melloney: “In the project chartering phase, we appoint a cross-functional project manager who serves as the primary point of contact for the sponsor. The project manager then assembles a core team consisting of experts representing their respective disciplines. A typical project team has representation from our ADME, preformulation and chemistry departments. During project execution, the cross-functional project manager organizes biweekly internal meetings to discuss results and address criticalities. He also sets up biweekly meetings with the sponsor, during which we share results and agree on next steps.”
Gerjan: “This approach creates little additional overhead but has proven highly effective in our integrated chemical-pharmaceutical development projects. It stimulates us to focus on the project and it provides an opportunity for the customer to track progress. We are enthusiastic about having also set up this cross-functional project management structure for our drug discovery support services and are very much looking forward to forging new customer relationships in this area.”
|ARDENA’s Drug Discovery Support Services|
|In vitro pharmacology
|ADME / Bioanalysis
Plasma protein binding
Supply of intermediates
Supply of drug substance
Process safety evaluation
Process scalability evaluation
Intrinsic dissolution rate