mAbxience
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Drug Product
Advanced Modalities
Regulatory, Tech Transfer & Support Services
Company Overview
About
mAbxience is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Neurology
Quick Facts
HQ:Spain
Founded:2017
Employees:2,239
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
GH Genhelix S.A.
Calle Julia Morros (Pq. Tecnologico), S/N, Leon, 24009
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval TMXCEC
PMDA · #APR-L8DSPKZL · 2022-10-01
Drug Approval ATRFKG
PMDA · #APR-IBH7MW33 · 2019-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-XXS8RIYI
Issued: 2020-07-07
Expires: 2025-04-08
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-T6I19AOT
Issued: 2020-06-18
Expires: 2025-12-18
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-FI5AFET0
Issued: 2020-06-20
Expires: 2025-07-22
Health Canada GMP
Health Canada
Cert #: CERT-FAS4CW43
Issued: 2020-03-17
Expires: 2025-03-18
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Key facts about mAbxience
- mAbxience is headquartered in Spain.
- mAbxience was founded in 2017.
- mAbxience has 2,239 employees.
- mAbxience has one manufacturing site listed on CDMO Hub, in Leon, Spain.
- mAbxience's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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