Advanced Modalities
Excipients & Specialty Ingredients
Manufacturing & Lab Equipment
Company Overview
About
ScaleReady is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:1996
Employees:1,331
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
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval IHVUGE
PMDA · #APR-FUOT1EJ5 · 2022-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-IAC5G6MQ
Issued: 2020-05-28
Expires: 2025-04-17
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-PWL3QIPA
Issued: 2020-10-02
Expires: 2025-12-06
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-8P0RNORL
Issued: 2020-08-25
Expires: 2025-10-28
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-7GGC257Q
Issued: 2020-03-10
Expires: 2025-03-06
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Key facts about ScaleReady
- ScaleReady is headquartered in Germany.
- ScaleReady was founded in 1996.
- ScaleReady has 1,331 employees.
- ScaleReady's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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