HelixPharma Inc.

CDMO

Ireland

https://helixpharmainc.com

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Advanced Modalities

Contract Research Organization

Chemistry, Manufacturing and Controls

Regulatory, Tech Transfer & Support Services

Company Overview

About

HelixPharma Inc. is a leading contract development and manufacturing organization headquartered in Ireland. We specialize in Contract Research Organization (CRO), Biologics Manufacturer, Cell & Gene Therapy with state-of-the-art facilities serving clients globally.

Key Expertise

Stability Studies, mRNA Production, Regulatory Support, Supply Chain Management, Small Molecule API

Therapeutic Areas

Rare Disease

Metabolic

Quick Facts

HQ:Ireland

Founded:2003

Employees:865

Capabilities & Services

Core Capabilities

Biologics Drug Substance
Biologics Drug Product
Biologics Manufacturing

Types of Organization

Advanced Therapy Manufacturer (cell, gene, mRNA, ADC)

Biologics Manufacturer

Commercial Manufacturing

Contract Research Organization (CRO)

Drug Product Manufacturer (finished dosage, fill-finish, packaging)

Dosage Forms

Prefilled Syringe

Sterile Injectable

Containment Capabilities

OEB 5 (≤1 µg/m³)

Cytotoxic / ADC Handling

Production Scales

Phase II

Clinical

Pilot Scale

Batch Sizes

100L-1000L

10L-100L

5000L+

1L-10L

Markets Served

Asia-Pacific

Manufacturing Facilities

2 sites worldwide

HelixPharma Inc. - Headquarters

48 Industrial Way, Cork, Cork, 96890

View on Map

369,512 sq ft

Established 2012

Site Capabilities

6 capabilities

Liquid/Semi-Solid

Biologics Drug Product

Analytical Services

mRNA Production

Regulatory Support

Viral Vectors

HelixPharma Inc. - Zurich Facility

712 Technology Drive, Zurich, Zurich, 80809

View on Map

116,564 sq ft

Established 2009

Site Capabilities

5 capabilities

Supply Chain Management

Viral Vectors

Fill/Finish (Cartridges)

Small Molecule API

Liquid/Semi-Solid

Regulatory Approvals

Drug Approval 43EXGO

FDA · #APR-LOZTPL2K · 2019-11-01

Drug Approval TA2M3T

PMDA · #APR-VQH0PL1P · 2022-11-01

Case Studies

0 published case studies showcasing past projects, challenges and outcomes.

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-AGTKZL3F

Issued: 2020-01-15

Expires: 2025-12-14

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-NS3DW1I0

Issued: 2020-11-15

Expires: 2025-05-19

WHO GMP

World Health Organization

Cert #: CERT-934JZ0DS

Issued: 2020-02-26

Expires: 2025-01-18

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-PGKX5WG8

Issued: 2020-04-01

Expires: 2025-08-19

Customer Reviews

4.1

Overall Rating(Based on 10 reviews)

Project Management3.9

Technology Transfer4.0

On-Time Delivery3.6

Communication Responsiveness4.4

Innovation4.4

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Key facts about HelixPharma Inc.

HelixPharma Inc. is headquartered in Ireland.
HelixPharma Inc. was founded in 2003.
HelixPharma Inc. has 865 employees.
HelixPharma Inc. has 2 manufacturing sites listed on CDMO Hub, in Cork, Ireland and Zurich, Switzerland.
HelixPharma Inc.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

Find CDMOs like HelixPharma Inc.

Directory pages this company appears in, each with the full list of matching manufacturers.

CDMOs in Ireland CDMOs in Europe Biologics Drug Substance CDMOs Biologics Drug Product CDMOs Prefilled Syringe CDMOs Sterile Injectable CDMOs OEB 5 (≤1 µg/m³) CDMOs Cytotoxic / ADC Handling CDMOs

Key facts about HelixPharma Inc.

HelixPharma Inc. is headquartered in Ireland.

HelixPharma Inc. was founded in 2003.

HelixPharma Inc. has 865 employees.

HelixPharma Inc. has 2 manufacturing sites listed on CDMO Hub, in Cork, Ireland and Zurich, Switzerland.

HelixPharma Inc.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.