Andelyn Biosciences
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Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
Andelyn Biosciences is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:United States
Founded:2014
Employees:167
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
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 KNFR5P
EMA · #APR-OMP409L9 · 2019-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-746W1715
Issued: 2020-04-28
Expires: 2025-03-04
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-7CUBD5MM
Issued: 2020-07-19
Expires: 2025-09-03
WHO GMP
World Health Organization
Cert #: CERT-VJVZH4L1
Issued: 2020-04-24
Expires: 2025-09-22
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-RKATAUZ3
Issued: 2020-01-06
Expires: 2025-11-16
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Key facts about Andelyn Biosciences
- Andelyn Biosciences is headquartered in the United States.
- Andelyn Biosciences was founded in 2014.
- Andelyn Biosciences has 167 employees.
- Andelyn Biosciences's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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