VelaLabs offers analytical test methods for medicinal drugs in the clinical development phase as well as in the post-marketing phase. The analytical portfolio is based on the respective EMA and FDA guidelines and covers non-cellular and cellular methods.
All assays can be validated based on the relevant guidelines and white papers. Statistical evaluation and data transfer agreements can be discussed with the sponsor.
VelaLabs has currently 3 Analytical Project Manager (APMs) for the analytical coordination of your clinical study available. Cooperation with local companies expand our services for further support on clinical kits or study protocols.
1. Pharmacokinetic studies (PK)
- ECL (Electrochemiluminescence; MSD-MesoScaleDiscovery)
- Other methods upon request
2. Pharmacodynamic studies (PD)
- Dependent on request
- e.g. (q)PCR, Bioassays, cytokine multiplexing…
3. Immunogenicity profiling / Anti drug antibodies (ADA)
- Screening assay
- Confirmation assay
- Titer assay
- Neutralization assays
For the evaluation of the ADA various technologies (e.g. MSD or SPR/Biacore) as well our highly experience cell based assay group are available for discussion.
Send us your request HERE – we are looking forward to supporting your projects!