HALIX
HALIX B.V. is a contract development and manufacturing organization (CDMO) in Leiden, Netherlands, providing end-to-end development and GMP manufacturing for mammalian-produced biologics. Core activities include viral vectors, vaccines, recombinant proteins and antibodies. HALIX operates a multi‑cleanroom cGMP facility with single-use bioreactor capacity up to 1,000 L and integrated development, analytical and fill/finish capabilities.
Industries
Nr. of Employees
small (1-50)
Products
Viral Vector Manufacturing Services
Contract development and manufacturing organization (CDMO) services focused on mammalian expression systems for the production of viral vectors.
aseptic fill finish
GMP certified aseptic filling and liquid packaging services for clinical and commercial scale drug products, handling vial sizes from 2R up to 50 ml.
Aseptic fill and finish and lyophilization
GMP certified drug product production capabilities with small and large scale filling lines processing over a million vials per year.
Full QC
HALIX offers comprehensive quality control and release services for GMP products and intermediates, ensuring safety, purity, and potency through in-house testing and audited partner networks.
Full QC Services
HALIX supports biopharmaceutical manufacturing with a comprehensive QC package including qualified person release for clinical trials.
GMP viral product manufacturing
Development and commercialization support for viral products enabling the treatment and prevention of life-threatening conditions.
Viral Vector Manufacturing Services
Contract development and manufacturing organization (CDMO) services focused on mammalian expression systems for the production of viral vectors.
aseptic fill finish
GMP certified aseptic filling and liquid packaging services for clinical and commercial scale drug products, handling vial sizes from 2R up to 50 ml.
Aseptic fill and finish and lyophilization
GMP certified drug product production capabilities with small and large scale filling lines processing over a million vials per year.
Full QC
HALIX offers comprehensive quality control and release services for GMP products and intermediates, ensuring safety, purity, and potency through in-house testing and audited partner networks.
Full QC Services
HALIX supports biopharmaceutical manufacturing with a comprehensive QC package including qualified person release for clinical trials.
GMP viral product manufacturing
Development and commercialization support for viral products enabling the treatment and prevention of life-threatening conditions.
Services
End-to-end GMP manufacturing services for clinical and commercial biologics, including mammalian upstream and downstream processing and cleanroom production.
Process development and GMP manufacture for viral vectors and vaccines, supporting BSL1/BSL2 operations and collaborative scale-up for large projects.
Development and GMP production of therapeutic proteins including monoclonal and multispecific antibodies and biosimilars using mammalian expression systems.
Small and large scale aseptic filling and lyophilization services, including labeling, packaging, serialization and blinding/randomization for clinical trials.
In-house process and analytical method development to support CMC, release testing, stability and regulatory submissions, with options to outsource specific testing to qualified labs.
Platform service integrating late-stage R&D, cell/seed bank production, CMC support and access to in‑house GMP manufacturing to accelerate timelines to first-in-human trials.
End-to-end GMP manufacturing services for clinical and commercial biologics, including mammalian upstream and downstream processing and cleanroom production.
Process development and GMP manufacture for viral vectors and vaccines, supporting BSL1/BSL2 operations and collaborative scale-up for large projects.
Development and GMP production of therapeutic proteins including monoclonal and multispecific antibodies and biosimilars using mammalian expression systems.
Small and large scale aseptic filling and lyophilization services, including labeling, packaging, serialization and blinding/randomization for clinical trials.
In-house process and analytical method development to support CMC, release testing, stability and regulatory submissions, with options to outsource specific testing to qualified labs.
Platform service integrating late-stage R&D, cell/seed bank production, CMC support and access to in‑house GMP manufacturing to accelerate timelines to first-in-human trials.
Expertise Areas
- Biologics CDMO services
- Viral vector and vaccine production
- Intranasal and live-attenuated vaccine manufacturing support
- Recombinant protein and antibody manufacturing
Key Technologies
- Single-use bioreactors up to 1,000 L
- Mammalian cell culture (adherent and suspension)
- Transient transfection
- Tangential flow filtration (TFF)
News & Updates
Announcement of an integrated R&D-to-GMP acceleration platform to shorten timelines to first-in-human trials and provide access to a BioHub.
Interview with the CEO covering company strategy and developments.
Press release announcing a collaboration to support development and manufacturing of a next-generation intranasal live-attenuated COVID-19 vaccine candidate and platform, in partnership with an external vaccine developer.
Signed agreement to provide large-scale commercial drug substance manufacture for AZD1222.
Facility approved by the European Medicines Agency for drug substance production related to the AZD1222 vaccine.
Collaborated with University of Oxford consortium to scale up GMP manufacturing for a COVID-19 vaccine candidate (ChAdOx1 nCoV-19).
Announcement of an integrated R&D-to-GMP acceleration platform to shorten timelines to first-in-human trials and provide access to a BioHub.
Interview with the CEO covering company strategy and developments.
Press release announcing a collaboration to support development and manufacturing of a next-generation intranasal live-attenuated COVID-19 vaccine candidate and platform, in partnership with an external vaccine developer.
Signed agreement to provide large-scale commercial drug substance manufacture for AZD1222.
Facility approved by the European Medicines Agency for drug substance production related to the AZD1222 vaccine.
Collaborated with University of Oxford consortium to scale up GMP manufacturing for a COVID-19 vaccine candidate (ChAdOx1 nCoV-19).