Bioanalytical

Smithers Avanza Bioanalytical Services, a division of Smithers Avanza, supports the bioanalytical development of a wide range of therapeutics including CAR-T/TCR and other cellular therapeutics, monoclonal and bi-specific antibodies, fusion proteins, biosimilars/biobetters, among many other large-molecule drugs. We operate as a full service GLP/GCP and CLIA contract research organization.

Our senior staff averages 15+ years of experience in method development and method validation of PK/TK assays, anti-drug antibody assays (ADA), neutralizing antibody (NAb) and other cell-based assays as well as fit-for-purpose biomarker assays. Many of our subject matter experts have been involved in clinical trial studies that have led to the approval of biologics by regulatory agencies. All of our instrumentation is connected to our Watson 7.4 LIMS system for QC and data security. 

Smithers Avanza has extensive experience with assays for both pre-clinical applications and all phases of clinical development,  phase I through phase IV. The laboratory is both GLP and CLIA.

Our assay services include the following:

  • Method Development
  • Method Transfer
  • Method Optimization
  • Method Validation
  • Sample Analysis

Supporting:

Instrumentation
Automation

Accreditations   Data Collection
CLIA-certified   Watson LIMS™ 7.4
GLP-compliant   Rees Environmental Monitoring System
MD Dept Health and Mental Hygiene license