Advanced Modalities
Analytical & Bioanalytical Services
Contract Research Organization
Company Overview
About
AXOlabs is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:2002
Employees:1,294
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 06S96V
Health Canada · #APR-NTVRADPD · 2019-08-01
Drug Approval X7D5F7
Health Canada · #APR-NN0AG4VW · 2022-12-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-RE2B3JH9
Issued: 2020-01-08
Expires: 2025-05-14
WHO GMP
World Health Organization
Cert #: CERT-IR5D991E
Issued: 2020-05-17
Expires: 2025-09-06
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-B3KIH0MR
Issued: 2020-12-05
Expires: 2025-11-16
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Key facts about AXOlabs
- AXOlabs is headquartered in Germany.
- AXOlabs was founded in 2002.
- AXOlabs has 1,294 employees.
- AXOlabs's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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