GeneTherapeutics GmbH

CDMO

Norway

https://genetherapeuticsgmbh.com

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Drug Product

Clinical Trial Supply & Logistics

Advanced Modalities

Qualification/Validation Services

Chemistry, Manufacturing and Controls

Company Overview

About

GeneTherapeutics GmbH is a leading contract development and manufacturing organization headquartered in Norway. We specialize in Contract Research Organization (CRO), Commercial Manufacturing with state-of-the-art facilities serving clients globally.

Key Expertise

Packaging & Labeling, mRNA Production, Regulatory Support, Biologics Drug Substance, Fill/Finish (Syringes)

Therapeutic Areas

Neurology

Quick Facts

HQ:Norway

Founded:2020

Employees:154

Capabilities & Services

Core Capabilities

Cytotoxic / ADC Handling
High-Potency API
Sterile Fill/Finish

Types of Organization

Analytical & Bioanalytical Laboratory

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

Dosage Forms

Topical / Transdermal

Production Scales

Pilot Scale

Clinical

Commercial Scale

Batch Sizes

1000L-5000L

1L-10L

10L-100L

Markets Served

North America

Europe

Manufacturing Facilities

2 sites worldwide

GeneTherapeutics GmbH - Headquarters

920 Technology Drive, Trondheim, Trondheim, 66219

View on Map

45,756 sq ft

Established 2002

Site Capabilities

3 capabilities

Lyophilization

Small Molecule Drug Product

Formulation Development

GeneTherapeutics GmbH - Trondheim Facility

410 Pharma Boulevard, Trondheim, Trondheim, 97524

View on Map

82,667 sq ft

Established 2018

Site Capabilities

6 capabilities

Liquid/Semi-Solid

Fill/Finish (Vials)

Biologics Drug Product

mRNA Production

Antibody-Drug Conjugates (ADC)

Analytical Services

Regulatory Approvals

Drug Approval QE083Q

Health Canada · #APR-H526EX74 · 2018-01-01

Drug Approval ABYH83

FDA · #APR-2WLUCXDY · 2021-03-01

Certifications

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-DTD3EPRS

Issued: 2020-07-28

Expires: 2025-10-23

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-VB7OMWRU

Issued: 2020-05-20

Expires: 2025-10-27

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-MQQIKUPO

Issued: 2020-04-10

Expires: 2025-06-02

Health Canada GMP

Health Canada

Cert #: CERT-UIZ5Y7J3

Issued: 2020-09-20

Expires: 2025-10-17

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Key facts about GeneTherapeutics GmbH

GeneTherapeutics GmbH is headquartered in Norway.
GeneTherapeutics GmbH was founded in 2020.
GeneTherapeutics GmbH has 154 employees.
GeneTherapeutics GmbH has 2 manufacturing sites listed on CDMO Hub, in Trondheim, Norway.
GeneTherapeutics GmbH's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

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Key facts about GeneTherapeutics GmbH

GeneTherapeutics GmbH is headquartered in Norway.

GeneTherapeutics GmbH was founded in 2020.

GeneTherapeutics GmbH has 154 employees.

GeneTherapeutics GmbH has 2 manufacturing sites listed on CDMO Hub, in Trondheim, Norway.

GeneTherapeutics GmbH's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.