From Gene to Vial to Patient: Lonza Experts Run Biotech Products Through a Gauntlet of Real-world Simulations Before Release
Hanns-Christian Mahler, head of Lonza Drug Products Services, and Ahmed Besheer, head of formulation development 2, talk about how Lonza is leading the way in providing an essential service to clinical partners.
In the field of CDMO drug development, the new gold standard is end-to-end service, or bringing a pharmaceutical from gene to vial to patient. In 2016 Lonza established its Drug Product Services (DPS) to realize this supply chain model for its partners and clients. Since then the DPS has grown to a workforce of over 250 experienced experts focused on safety, efficacy and quality. They reduce complexity and improve regulatory compliance for Lonza’s clinical partners. To ensure that Lonza’s pharmaceuticals perform as expected in real-world situations, the DPS team simulates the entire administration process until certain the patient will receive the correct dose of the highest quality. Lonza works with clients around the world, making this service indispensable to international partners and colleagues in clinical practice, since clinical circumstances and regulations can vary greatly from country to country. The DPS’s results also contribute to the basic science that informs drug creation and delivery, offering the opportunity for Lonza researchers to publish and share their discoveries with the larger scientific community.
Curious to Know More?
Listen to the conversation with Lonza researchers at Drug Product Services in this special, in-house episode of the podcast "A View On."KEY TERMS:
Administration set: The set of tools and devices that allow for a clinical practitioner to administer a drug to a patient, for example via an intravenous IV setup. This usually includes the vial, the syringe to inject the drug into the IV bag, the bag itself along with the IV line, in-line filter and the cannula.
Administration process: The process by which clinicians employ the administration set to deliver the drug. Lonza’s DPS makes sure the interaction with the various materials and even possible human error do not adversely impact the product quality or interfere with dosing, e.g. due to drug adsorption.
In-use stability: The stability of the product during handling and administration considering its interaction with all the materials and forces needed to administer the product, such as the dilution in the delivery medium, potential adsorption to surfaces, hold times and administration process and environmental conditions like temperature and light. The keystone of DPS research and service is to ensure in-use stability for its clinical partners.