BioNTech
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Drug Product
Advanced Modalities
Company Overview
About
BioNTech is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:2001
Employees:1,732
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
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
BioNTech Manufacturing Marburg GmbH
Emil-von-Behring-Str. 76, Marburg, 35041
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
Regulatory Approvals
Drug Approval EVGOS3
Health Canada · #APR-7IWT3LEF · 2022-10-01
Drug Approval I3ZAEL
FDA · #APR-2W40PN95 · 2021-07-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-GTDALXL2
Issued: 2020-07-03
Expires: 2025-01-24
WHO GMP
World Health Organization
Cert #: CERT-K8S2J3CZ
Issued: 2020-10-24
Expires: 2025-02-06
Health Canada GMP
Health Canada
Cert #: CERT-H9ZTGEPR
Issued: 2020-04-14
Expires: 2025-10-26
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Key facts about BioNTech
- BioNTech is headquartered in Germany.
- BioNTech was founded in 2001.
- BioNTech has 1,732 employees.
- BioNTech has one manufacturing site listed on CDMO Hub, in Marburg, Germany.
- BioNTech's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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