The HALIX facility
Our 6,700 m2 facility was built in 2019 and is equipped with advanced equipment for the development and GMP production of biologics. Located in the Netherlands at the Leiden Bio Science Park, we offer end-to-end services to meet your needs from the preclinical to the commercial stage.
- Equipment and facility suitable for clinical and commercial cGMP manufacturing using mammalian expression systems
- Design compliant with EMA/FDA guidelines and containment level BSL2, with the potential to upgrade to BSL3 with short lead time
- EU GMP grade C production suites for drug substance manufacturing
- EU GMP grade B production suites for drug product manufacturing
- Independent air treatment per clean room suite
- Continuous GMP monitoring system to secure all relevant GMP operations
- Experience with adherent and suspension cell lines
- Upstream processing, from small scale up to 1,000 L scale
- Purification using depth filtration, tangential flow filtration (TFF) and chromatography systems
- Single use disposable equipment
- Small and large scale aseptic filling up to 20,000 vials
- Capabilities and know-how on handling different types of viral vectors and viruses such as AAV, Adenovirus, and Influenza virus
- Experience with different classes of therapeutic proteins such as novel monoclonal antibodies, bispecific antibodies, biosimilars, and recombinant proteins
- Aseptic fill and finish and lyophilization of proteins, peptides, vaccines, allergens, small molecules, and viruses (BSL2)
Track record of successful, timely delivery of demanding projects
“This collaboration with HALIX will ensure high quality, rapid and secure manufacture of clinical supplies for our current and future products. […] We developed a manufacturing process around the use of transient transfection to accelerate timelines and reduce costs, whilst delivering product of the highest quality. In HALIX we found the ideal partner; experience in transient transfection, modern facilities, strong leadership and a laser focus on delivery to bring NVG-111 from contract signature to vials of clinical drug in less than seven months.“
Kieran O’Donovan, COO & CTO at NovalGen
“When we were looking for a CDMO partner to support the aseptic fill and finish activities, testing, and packaging of our lead compound with reliability and expertise, HALIX was the perfect fit. HALIX offered a full service to match our needs and provided us with the flexibility and collaboration that was necessary to deliver T-Guard® to clinical trials. HALIX’s attention to detail and close, transparent communication enabled us to meet our deadlines, successfully overcome challenges, and ensure the success of the project.”
Dr. Ypke van Ossterhout, Founder and CEO of Xenikos
“We achieved on-time delivery of a completely novel vaccine while starting from a brand new empty facility and having to assemble all of the necessary equipment, processes, and qualifications for commercial production along the way. This success was only possible through our tight collaboration with AstraZeneca and our team’s internal work with military precision.“
Dennis Verbart, Senior Director Science and Technology at HALIX
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State-of-the-art GMP facility at Leiden Bio Science Park
We are a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics, enabling the treatment and prevention of life threatening conditions such as cancer, COVID-19, and other diseases. We are steadily growing our teams with plenty of interesting positions e.g. in our development, manufacturing, and quality departments.