Bioanalysis
Our bioanalysis team – scientific excellence meets exceptional customer care
- Experienced team: specialised in developing and validating assays and analysing samples for small and large molecules in diverse biological matrices, including plasma, serum, whole blood, tissues and more.
- Seamless communication: open and solution-oriented customer communication, with quick and easy internal cross-functional communication enabled by conducting all operations under one roof.
- Regulatory expertise: State-of-the-art facilities that are GLP-accredited and inspected by regulatory agencies such as the FDA, EMA and ANVISA, to help ensure compliance, outstanding quality of data and documentation, and that your submissions meet the highest standards.
- End-to-end and comprehensive solutions:
- Guidance in every phase of development: from early-stage discovery and preclinical development to clinical trials and regulatory approval.
- Comprehensive bioanalysis services all under one roof resulting in less shipments, e.g. cross-functional bioanalysis support for antibody-drug-conjugates (ADCs) by providing assays to measure conjugated and total antibody as well as antibody-conjugated drug and free drug.
- Streamlined processes: optimised workflows and advanced technologies, helping ensure that your drug development program progresses smoothly and efficiently, reducing time to market.
- Specialised services: handling of sensitive compounds and assay customisation to meet the specific needs of each project, including analysis of samples from studies in patients with infectious diseases (biosafety laboratory level 2 (BSL2) certification).
Immunoassays
By leveraging the specificity of antigen-antibody interactions, immunoassays enable precise detection of a wide array of large molecules. Our daily business includes PK analysis, immunogenicity assessments, and studies of new biological entities or biosimilars, as well as large molecule PD/biomarker analysis. To support individual studies, we offer different assay platforms for LBA and cell-based assays, depending on the bioanalytical questions to be answered.
Chromatography and mass spectrometry
Our chromatography and mass spectrometry laboratories offer high-sensitivity analysis for a wide range of small and large molecules across all stages of drug development. Equipped with advanced LC-MS/MS systems, we offer precise, rapid data for metabolite identification, pharmacokinetics and biomarker studies in diverse biological matrices. Our methods and technologies are designed to meet your specific requirements for accuracy and turnaround time.
learn more
PK/TK data analysis
At Nuvisan, we are committed to provide a seamless and comprehensive service experience. By conducting both sample and data analysis in-house, we eliminate the need to coordinate between multiple vendors. This leads to smoother and more efficient project management by reducing potential data management challenges. Furthermore, this integrated approach allows for more accurate interpretation and validation of your data, which we can conveniently combine into a single analytical report.
learn moreContact us
Email us
Talk to us
Our locations
Neu-Ulm (headquarters)
Wegenerstrasse 13
89231 Neu-Ulm
Germany
Berlin
Muellerstrasse 178
13353 Berlin
Germany
Sophia Antipolis
2400 route des Colles
06410 Biot
France
Grafing
Am Feld 32
85567 Grafing
Germany
Waltrop
Im Wirrigen 25
45731 Waltrop
Germany