Custom Biologics
Regulatory-compliant bioanalytical contract research laboratory specializing in assay development, validation, and testing for biologics, vaccines, cell and gene therapies, and molecular diagnostics. Operates under GLP/GMP-aligned quality systems and supports preclinical/CMC through clinical stages with laboratory testing, method qualification/validation, and regulatory documentation suitable for submissions to global agencies.
Industries
Nr. of Employees
small (1-50)
Custom Biologics
Toronto, Ontario, Canada, North America
Products
Isothermal nucleic acid amplification point-of-care diagnostic platform
A point-of-care molecular diagnostic platform based on isothermal nucleic acid amplification optimized for rapid detection of viral and bacterial targets in clinical, environmental, and food matrices; reagent formulations may be lyophilized for room-temperature storage.
Isothermal nucleic acid amplification point-of-care diagnostic platform
A point-of-care molecular diagnostic platform based on isothermal nucleic acid amplification optimized for rapid detection of viral and bacterial targets in clinical, environmental, and food matrices; reagent formulations may be lyophilized for room-temperature storage.
Services
Custom design, qualification, and full validation of bioassays to support preclinical, CMC, and clinical testing and regulatory submissions.
Tiered ADA testing and neutralizing antibody assays including screening, confirmatory, titering, and cell-based neutralization assays.
Vector identity, genome titer, infectivity, potency, capsid quantitation, stability, and biodistribution testing to support preclinical CMC and clinical programs.
Development of rapid nucleic acid amplification assays suitable for point-of-care and laboratory settings, including lyophilized reagent formats for room-temperature storage.
Validated testing for product stability, lot release, and clinical/market access under GMP-aligned procedures and controlled schedules.
Custom design, qualification, and full validation of bioassays to support preclinical, CMC, and clinical testing and regulatory submissions.
Tiered ADA testing and neutralizing antibody assays including screening, confirmatory, titering, and cell-based neutralization assays.
Vector identity, genome titer, infectivity, potency, capsid quantitation, stability, and biodistribution testing to support preclinical CMC and clinical programs.
Development of rapid nucleic acid amplification assays suitable for point-of-care and laboratory settings, including lyophilized reagent formats for room-temperature storage.
Validated testing for product stability, lot release, and clinical/market access under GMP-aligned procedures and controlled schedules.
Expertise Areas
- Bioanalytical assay development and validation
- Immunogenicity assessment and neutralizing antibody testing
- AAV and viral vector characterization
- Molecular diagnostics and nucleic acid testing
Key Technologies
- Droplet digital PCR (ddPCR)
- Quantitative PCR (qPCR/RT-qPCR)
- Isothermal nucleic acid amplification (INAAT)
- Enzyme-linked immunosorbent assays (ELISA/ECLIA)
News & Updates
Exhibited to present GLP-/GMP-compliant bioanalytical testing services for biologics, biosimilars, and gene therapies; onsite team included quality and executive leadership.
Participation at PBSS event discussing gene therapy analytics, AAV characterization, potency assays, and bioanalytical method development for IND strategies.
Exhibited at BIO 2025 to discuss bioanalytical needs in cell and gene therapies, vaccines, and biologics.
Explains the role of AAV potency assays in CMC planning, challenges in AAV characterization, and recommended assay platforms for potency and vector analytics.
Overview of core elements for a pharmaceutical quality system including quality-driven processes, environmental controls, communication/transparency, and consistent platform quality (IQ/OQ/PQ).
Exhibited to present GLP-/GMP-compliant bioanalytical testing services for biologics, biosimilars, and gene therapies; onsite team included quality and executive leadership.
Participation at PBSS event discussing gene therapy analytics, AAV characterization, potency assays, and bioanalytical method development for IND strategies.
Exhibited at BIO 2025 to discuss bioanalytical needs in cell and gene therapies, vaccines, and biologics.
Explains the role of AAV potency assays in CMC planning, challenges in AAV characterization, and recommended assay platforms for potency and vector analytics.
Overview of core elements for a pharmaceutical quality system including quality-driven processes, environmental controls, communication/transparency, and consistent platform quality (IQ/OQ/PQ).