Analytical & Bioanalytical Services
Contract Research Organization
Company Overview
About
Profacgen is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:United States
Founded:1993
Employees:1,377
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
Regulatory Approvals
Drug Approval ONDLB5
Health Canada · #APR-8VEWKM7V · 2019-08-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ORBN6KXH
Issued: 2020-10-12
Expires: 2025-11-08
WHO GMP
World Health Organization
Cert #: CERT-XPQW59M6
Issued: 2020-01-14
Expires: 2025-07-09
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Key facts about Profacgen
- Profacgen is headquartered in the United States.
- Profacgen was founded in 1993.
- Profacgen has 1,377 employees.
- Profacgen's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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