This website uses cookies to improve functionality and performance. With a click on the OK button you are giving implied consent to the use of cookies on this website.
More information
EnglishDeutsch
de
EnglishDeutsch
de
Login Environment Pharma

Immunoassay - analysis and characterization of antibodies and more

SYNLAB pharma has collected extensive experience in the area of Immunogenicity testing (GLP, GCP) over twenty years.

Project specific immunogenicity testing strategies for preclinical and clinical studies have been successfully developed, validated and applied to sample analysis for clients worldwide.

The strategy determining anti-drug-antibodies includes test methods for:

  • Total antibody determination
  • Neutralising antibody determination (functional cell based assays for screening and confirmation of ADA positive samples)
  • Characterisation of ADA (lg-subclasses/epitope binding of anti-drug antibodies)
  • Development, optimisation and validation according to relevant guidelines and actual recommendations
  • Transfer and cross-validation
  • Analysis of pre-clinical and clinical samples
  • Consulting
Contact us



News & Events

View All
Fellbach wird neuer Laborstandort
Nach zweijähriger Planungs- und Umbauphase entstand in Fellbach das neue Labor der SYNLAB Analytics & Services Germany GmbH.
Aug 10, 2018 Continue
Determination of the Impurity N-Nitroso dimethyl amine (NDMA) in Drug Substances with GC-MS

Due to contamination of a drug substance with the potential mutagenic substance N-Nitroso dimethyl amine (NDMA) a massive recall campaign was initiated for the related drug products. SYNLAB Pharma offers a GC-MS test for testing the absence of NDMA in drug substances and drug products.

Please contact our experts.

Jul 13, 2018 | Pharma Continue
New Services in Regulatory Compliance for Biologics

With immediate effect, SYNLAB Pharma provides a broad support in the field of Regulatory Compliance of Biologics development. With this new services we support specifically start-ups, small to medium sized biotech companies, which require professional consultancy and project execution in regulatory project design.

For further questions, please contact:

pharma@synlab.com

Jun 18, 2018 | Pharma Continue
View All