Drug Product
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Company Overview
About
BioCina is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Australia
Founded:2015
Employees:1,758
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
BSL-2 (Biosafety Level 2)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Europe
Regulatory Approvals
Drug Approval RFR0IC
Health Canada · #APR-BO81J4NM · 2021-07-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-C1LRDOIM
Issued: 2020-11-26
Expires: 2025-02-01
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-ZK1UJSX8
Issued: 2020-10-12
Expires: 2025-07-04
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-2JYC6RVD
Issued: 2020-03-21
Expires: 2025-05-03
Health Canada GMP
Health Canada
Cert #: CERT-EOEB639D
Issued: 2020-11-04
Expires: 2025-09-24
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Key facts about BioCina
- BioCina is headquartered in Australia.
- BioCina was founded in 2015.
- BioCina has 1,758 employees.
- BioCina's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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