Helix Biotech, Inc.
Is this your company? Claim this profile
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
Helix Biotech, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:2015
Employees:2,485
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Helix Biotech, Inc
1460 Breda Dr, Knoxville, Tennessee, 37918
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
Regulatory Approvals
Drug Approval 0BFUCH
PMDA · #APR-3LXK18S4 · 2020-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-4MJPZSR5
Issued: 2020-10-27
Expires: 2025-11-06
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-8ERV24N1
Issued: 2020-06-06
Expires: 2025-01-01
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-HZMXUB1H
Issued: 2020-09-06
Expires: 2025-01-21
Health Canada GMP
Health Canada
Cert #: CERT-WIR3QIP7
Issued: 2020-10-16
Expires: 2025-07-05
Loading CDMO intelligence...
Key facts about Helix Biotech, Inc.
- Helix Biotech, Inc. is headquartered in the United States.
- Helix Biotech, Inc. was founded in 2015.
- Helix Biotech, Inc. has 2,485 employees.
- Helix Biotech, Inc. has one manufacturing site listed on CDMO Hub, in Knoxville, United States.
- Helix Biotech, Inc.'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
Find CDMOs like Helix Biotech, Inc.
Directory pages this company appears in, each with the full list of matching manufacturers.