---
name: Custom Biologics
slug: custombiologics
site: cro
website_domain: custombiologics.com
summary: Global bioanalytical CRO offering GLP-compliant assay development, validation, and testing for large-molecule biopharmaceuticals. Supports pre-clinical/CMC and clinical stages, including GMP-lot and market release testing.
tagline: Exceptional Science. Uncompromising Quality.
founded_year: 
employee_count_band: 
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parent_name: 
parent_slug: 
hq_country: 
tier2_domain_verified: false
updated_at: 2026-11-01T07:02:27.593Z
services_count: 3
modalities_count: 1
indications_count: 0
locations_count: 0
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Custom Biologics

Exceptional Science. Uncompromising Quality.

Listed on cro.directory.

## Summary

Global bioanalytical CRO offering GLP-compliant assay development, validation, and testing for large-molecule biopharmaceuticals. Supports pre-clinical/CMC and clinical stages, including GMP-lot and market release testing.

## Services

- Bioanalysis
- Analytical Method Development & Validation
- Genomics & Sequencing Services

## Modalities

- Biologics (Other)

## Long description

Custom Biologics is a bioanalytical contract research organization that provides specialized, GLP-compliant assay development, validation, and testing services for biopharmaceutical drug development.

**Services and focus**

- GLP-compliant bioanalytical testing for large-molecule (biologic) drugs
- Assay development and validation
- GMP-lot and market release testing
- Drug-specific tests
- Genomics DASL-Rapid™ offering
- Support for pre-clinical/CMC and clinical stages of drug development

The company also publishes resources on topics such as biosimilar bioanalysis, AAV potency assays in preclinical CMC, and pharmaceutical quality systems.

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- [SoCal Biosciences, Inc.](/companies/socalbiosci) (Bioanalysis, Analytical Method Development & Validation) — [Compare](/compare/custombiologics/socalbiosci)
- [BioQual Solutions Inc.](/companies/bioqualsolutions) (Bioanalysis, Analytical Method Development & Validation) — [Compare](/compare/bioqualsolutions/custombiologics)

_Profile last updated: 2026-11-01T07:02:27.593Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.