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 CDMO Services
End-to-end contract development and manufacturing services for viral vectors and vaccines from preclinical to commercial scale.
Recombinant Protein and Antibody Manufacturing
GMP manufacturing services for recombinant proteins and antibodies used in therapeutic applications.
Aseptic Fill and Finish and Lyophilization
GMP-certified drug product production including aseptic filling, finishing, and lyophilization for viral and protein products.
Process Development and Scale-Up Services
Development and scale-up of production processes from small to large scale for viral vectors and biologics.
Viral Vector CDMO Services
End-to-end contract development and manufacturing services for viral vectors and vaccines from preclinical to commercial scale.
Recombinant Protein and Antibody Manufacturing
GMP manufacturing services for recombinant proteins and antibodies used in therapeutic applications.
Aseptic Fill and Finish and Lyophilization
GMP-certified drug product production including aseptic filling, finishing, and lyophilization for viral and protein products.
Process Development and Scale-Up Services
Development and scale-up of production processes from small to large scale for viral vectors and biologics.
Services
GMP drug substance and drug product manufacturing
End-to-end GMP manufacturing services for clinical and commercial biologics, including mammalian upstream and downstream processing and cleanroom production.
Viral vector and vaccine manufacturing
Process development and GMP manufacture for viral vectors and vaccines, supporting BSL1/BSL2 operations and collaborative scale-up for large projects.
Recombinant protein and antibody manufacturing
Development and GMP production of therapeutic proteins including monoclonal and multispecific antibodies and biosimilars using mammalian expression systems.
Aseptic fill‑finish and lyophilization
Small and large scale aseptic filling and lyophilization services, including labeling, packaging, serialization and blinding/randomization for clinical trials.
Process development, analytical development and QC
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.
Integrated R&D-to-GMP acceleration platform
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.
GMP drug substance and drug product manufacturing
End-to-end GMP manufacturing services for clinical and commercial biologics, including mammalian upstream and downstream processing and cleanroom production.
Viral vector and vaccine manufacturing
Process development and GMP manufacture for viral vectors and vaccines, supporting BSL1/BSL2 operations and collaborative scale-up for large projects.
Recombinant protein and antibody manufacturing
Development and GMP production of therapeutic proteins including monoclonal and multispecific antibodies and biosimilars using mammalian expression systems.
Aseptic fill‑finish and lyophilization
Small and large scale aseptic filling and lyophilization services, including labeling, packaging, serialization and blinding/randomization for clinical trials.
Process development, analytical development and QC
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.
Integrated R&D-to-GMP acceleration platform
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)