NUVISAN’s search for a new system to perform pharmacokinetic immunoassays was based on a number of critical parameters, including sample volume, analytical range, sensitivity, and hands-on processing time. Seeing the advantages of Gyrolab technology, NUVISAN acquired Gyrolab xPlore™ in 2019 and immediately performed an instrument qualification and software validation according to FDA 21 CFR Part 11 before using the system in the support of studies.
In particular, the immunoassay department at NUVISAN has a frequent need to minimize the use of biological sample material. Dr Uwe Kärcher, Director Immunoassays, explains, “Gyrolab technology enables us to perform nanoliter-scale assays with very small sample volumes. This can be important in the case of early phase discovery projects, the analysis of rare matrix, or special circumstances such as pediatric studies where only small volumes of sample may be available. Through the conservation of resources and material bioanalysis is thus more sustainable. We think sustainability regarding animal and patient matrices is very important and Gyros Protein Technologies offers a forward-looking perspective in this regard. Besides microsampling, minimal sample consumption means that we have adequate sample to run more than one immunoassay type if needed. This is especially critical for anti-drug-antibody (ADA) assays where screening, confirmation and titer determination runs are typically required.”
The immunoassay department at NUVISAN has also appreciated another key advantage of the Gyrolab platform — that being the minimal hands-on time needed to perform an analytical run. Added to that, they have seen that the automated system minimizes intra-/inter-run variations, facilitates the transfer of assays from clients, and provides the high throughput needed to manage large numbers of samples. Dr Uwe Kärcher adds, “At the same time Gyrolab technology is still open and flexible for assay optimization. The Gyrolab system enables us to conserve resources including time and matrix without losing performance. This makes the system unique and a very valuable tool that allows us to work more efficiently.”
Dr Uwe Kärcher also states that NUVISAN is very pleased with the commitment from Gyros Protein Technologies. “The company provides extraordinary support and focuses on good communication, a trait also embodied at NUVISAN. It is a very congenial supplier relationship with Gyros Protein Technologies providing quick and capable answers to our questions. Their support is excellent and we are happy to work with them.”
NUVISAN Pharma Services is an international service provider for clinical studies, laboratory services and contract manufacturing (CRO / CDMO) with several sites and clinics in Germany and France. Since 1979, NUVISAN is serving the needs of clients in early and late clinical development. The CRO’s major strength is the ability to provide a wide range of pharmaceutical services under the same roof, from support in formulation in early phases through non-clinical studies and clinical trials to bioanalysis.
NUVISAN has been GLP-accredited since 1990, is regularly inspected by the FDA and EMA, and has been ANVISA-certified since 2005. NUVISAN scientists have in-depth knowledge of regulatory agency requirements together with a strong pharmaceutical industry background. This ensures their clients that data they provide meets the quality demanded for each step of development, leading to successful submissions. The client-CRO relationship is very important for NUVISAN, focusing on good communication and cooperation.
In February 2020, NUVISAN entered into a collaboration with Bayer to create a new research unit in Berlin which will enlarge NUVISAN’s portfolio of pharmaceutical services. As a result, NUVISAN can now provide support from research up to completion of phase II from one single supplier – from the molecule to the patient.
NUVISAN’s immunoassay department offers different types of ligand binding assays for analysis of protein/peptide molecules as well as cell-based assays/flow cytometry using state-of-the-art equipment. Their services include method development, transfer, and validation as well as bioanalysis of biological samples from in-house (pre-clinical and clinical) and external studies. Their expertise covers, inter alia, pharmacokinetic assays, and immunogenicity, biomarker, and biosimilar studies.
Find out more about NUVISAN at https://www.nuvisan.com/.