Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
GC Biopharma is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:South Korea
Founded:2001
Employees:631
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 4 (1-10 µg/m³)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Global
Manufacturing Facilities
1 site worldwide
GC Biopharma Corp_Ochang Plant
586, Gwahaksaneop 2-ro, Ochang-eup, Cheongwon-gu, Cheongju, Chungcheongbuk-do, 28119
Site Capabilities
5 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
Regulatory Approvals
Drug Approval 7XVB96
EMA · #APR-HVH275SF · 2020-08-01
Drug Approval OSE5IM
FDA · #APR-RK81HSJR · 2018-10-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ATV0HU9T
Issued: 2020-08-18
Expires: 2025-05-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-UPF6S2YH
Issued: 2020-12-02
Expires: 2025-02-05
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-IG8RGN0T
Issued: 2020-11-16
Expires: 2025-07-09
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Key facts about GC Biopharma
- GC Biopharma is headquartered in South Korea.
- GC Biopharma was founded in 2001.
- GC Biopharma has 631 employees.
- GC Biopharma has one manufacturing site listed on CDMO Hub, in Cheongju, South Korea.
- GC Biopharma's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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