Bioanalysis & Biopharmaceuticals characterization offering

Bioanalysis : High-value bioanalysis services to move your compound a step forward with regulatory expertise

Fit-to-purpose or off-the-shelf assay methods

Our experience and highly qualified teams can support you with selecting the best appropriate assay method in accordance with your needs, the Good Professional practices and international standards.
The quantification of the biomarkers identified can be performed in liquid or tissular environments.

Expertise of various assay technologies

Oncodesign harnesses classic technologies such as immuno-analysis, chemical analysis and molecular biology, mass flow cytometry (CyTOF) and cellular sorting in BSL3 conditions. We have several BSL3 installations in which we process infectious specimens. We also offer combined technologies such as HPLC-MS2.

We support your data analysis all throughout your drug development

Oncodesign highly skilled scientists are available to identify, optimize & assess your NCE & NBE candidates.

Analysis of your New Chemical and Biological Entities

Development and validation of analytical methods for drugs:

  • Improvement and validation of analytical methods for drugs
  • Technology for transferring analytical methods for drugs
  • Systematic analysis of drugs

Analysis of membrane proteins

`The level of protein expression and an understanding of the proteins’ functional roles, such as in the drug’s absorption, distribution, metabolism, elimination, toxicity and efficacy (ADME-T/efficacy) are important for drug discovery and development.


Oncodesign’s exclusive MS2Plex® offering quantifies membrane proteins in a GLP environment such as CYPs, UGTs, ABC and SLC carriers involved in ADME-T studies for drug candidates.

Immuno-monitoring of patients

Oncodesign has a set of skills and equipment dedicated to monitoring innate and adapted immune responses in cell cultures, or after administration of a drug candidate in animals (non-human primates - NHPs, mice or other animal species), healthy volunteers and patients.


This immunomonitoring aims to establish the efficacy and safety of vaccines, adjuvants and immune therapies.

Immuno-analysis

Oncodesign possesses an integrated offering from development through to routine assay of your compounds in liquid and tissular environments. This offering is performed in a certified Good Laboratory Practice environment:


  • Custom development of dosage methods

  • Update and validation of biomarker dosages
  • Bioanalysis supporting translational research and preclinical and clinical studies

  • Supply of ready-to-use dosage kits customized for implementation either in your facilities or n medical analysis labs.

Microbiological monitoring

Oncodesign manages the samples collected from volunteers and from patients enrolled in clinical trials. We can work as a central laboratory and provide you with a range of management solutions for your samples in our biobankbank.

We can also handle the microbiological monitoring of your infectious samples (class 2 and class 3 human pathogens, including transmissible respiratory agents such as influenza virus) in our Level 2 and 3 Biosecurity laboratories.

Contact us today to talk about your project

 

Biopharmaceuticals characterization offering

Key solutions for successful development of Your biopharmaceutical product

Biologics characterization is essential in your drug development cycle

While developing your biologics, you need, all throughout the development process, to verify the identity, purity, quality and efficacy of your peptides, proteins, antibodies or vaccines. Those data are pivotal in the development of the drug so as to mitigate the risk at every step. Those data give you the right information to make the right decision regarding formulation and production.

Keys solutions to demonstrate the quality of the product

Our testing strategy is to match with your specific needs for drug CMC & quality interest for both DS & DP. To that end, we set-up a design according to the status of your overall development program. In parallel, we define together the best testing drivers according to the level of characterization of your biologics for the DS.

Building on our previous experience, we provide & execute a cogent plan addressing the testing strategy needed upon ICH guidances.

Your partner to assess the quality features of your product

We aim to establish accurate analytical requirements to fully characterize & control biopharmaceutical products as of production, downstream processing of therapeutics to formulation.Thanks to our large spectrum of analytical methods, we assist you to determine all key features that may affect the quality such as structure, heterogeneity, aggregation, impurities & stability.

Contact us today to talk about your project