Custom Biologics

Overview

Custom BiologicsT is Canada's leading CRO for GxP-compliant bioanalytical testing services that apply to all stages of large and small-molecule pharmaceutical drug development.  

Custom BiologicsT has a proven track record spanning more than 10 years for conducting GLP-compliant bioanalytical, ligand-binding and cell-based bioassays to define the activity and pharmacokinetics of large and small molecules, biomarkers and drug candidates.

We are experienced with assay design and validation to support residual contamination testing from many different host cell expression systems including, bacterial, mammalian and plant.

A list of some of the biosimilars and respective assays we have experience with can be found here, http://custombiologics.com/biologics/biosimilars/

Custom Biologics is fully versed with current regulatory guidelines (FDA/USP/ICH) for implementing bioanalytical, immunological cell-based and molecular diagnostic assays.   All study data generated by Custom BiologicsT are subject to rigorous quality assurance review to ensure compliance with FDA regulations 21 CFR Parts 11 and 58.

At Custom Biologics we appreciate how critical and timely progress in biologics scientific research can be. We also recognize that the underlying ingredient of novel scientific discoveries is great science. We are committed to working closely with you and providing you the highest level of scientific integrity, dedication and customer service.

Standards & Methodologies

Bioanaltyical method development and validation services are conducted in compliance with the United States Food & Drug Administration (FDA), Guidance for Industry Bioanalytical Method Validation (21 CFR Part 58) and in accordance with Custom Biologics'T Standard Operating Procedures. Pharmaceutical testing, bio-analytical method validation and data analysis are conducted under GLP regulations according to FDA guidelines (21 CFR Part 58), 21 CFR Parts 11 and 58 Compliant

Qualifications, Certifications, Accreditations & Licenses

Bioanaltyical method development and validation services are conducted in compliance with the United States Food & Drug Administration (FDA), Guidance for Industry Bioanalytical Method Validation (21 CFR Part 58) and in accordance with Custom Biologics' Standard Operating Procedures. Pharmaceutical testing, bio-analytical method validation and data analysis are conducted under GLP regulations according to FDA guidelines (21 CFR Part 58), 21 CFR Parts 11 and 58 Compliant