Analytics for biologics and vaccines

The development and approval of new treatments like antibody therapeutics, immunotherapies and VLP-based vaccines requires innovative analytical methods and quality attribute test panels.

At NRC, biologics and vaccine developers leverage our analytics expertise to advance products from discovery to application for clinical trials. We excel at designing non-standard assays and can help you fill gaps in lead identification, characterization, bioanalysis, and biomarkers. We can work with you to define your target product profile (TPP) and develop a lead candidate. Our biophysical and physicochemical characterization expertise supports you as you prepare your Clinical Trial Application (CTA) in Canada or Investigational New Drug (IND) application in the USA. We can identify, evaluate and monitor your lead candidate’s critical quality attributes (CQA), and provide you with documentation in line with regulatory requirements.

We also transfer our data and methods to Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), enabling them to offer new services while strengthening the Canadian biopharma ecosystem.

R&D expertise

Contacts

Susan Twine
Section Head, Analytics
Telephone: 613-949-7545
EmailSusan.Twine@nrc-cnrc.gc.ca

Donald Paquette
Team Leader, Quality Attributes and Characterization
Telephone: 514-496-6317
EmailDonald.Paquette@cnrc-nrc.gc.ca

Supplemental content

An expert analyzes molecules by mass spectrometry.

Case study

NRC is successfully partnering with innovative Canadian biotechnology company Zymeworks to validate their in silico algorithms for designing bi-specific antibodies capable of binding two different therapeutic targets. NRC's characterization expertise supported Zymeworks as they secured strategic partnerships with multinational pharmaceutical companies Merck, Eli Lilly, Celgene, and GSK.

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