Halix

Overview

HALIX is a contract development and manufacturing organization (CDMO) focused on mammalian expression systems for viral vectors, viral vector vaccines, and recombinant proteins. Established in 2012 as a spin-off of HAL Allergy, the company combines decades of GMP expertise with startup agility to support biotech and pharma partners from development through commercial production.

Facility & Infrastructure

Located in the Leiden Bio Science Park in the Netherlands, HALIX operates a 6,700 m² facility built in 2019 with:

• 10 clean rooms ("box in box" design)
• 7 bioreactors with upstream processing capacity up to 1,000 L scale
• 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 systems
• BSL2 containment with potential upgrade to BSL3
• Design compliant with EMA/FDA guidelines

Core Capabilities

Viral Vector & Vaccine Manufacturing:

• Experience with AAV, Adenovirus, and Influenza virus
• Transient transfection expertise for accelerated timelines
• Aseptic fill and finish and lyophilization of viruses (BSL2)

Recombinant Protein Manufacturing:

• Monoclonal antibodies, bispecific antibodies, biosimilars, and recombinant proteins
• Adherent and suspension cell line experience
• Purification via depth filtration, tangential flow filtration (TFF), and chromatography
• Single-use disposable equipment

Fill & Finish:

• Small and large scale aseptic filling up to 20,000 vials
• Lyophilization of proteins, peptides, vaccines, allergens, small molecules, and viruses
• Labeling and packaging with custom layouts and randomization

Complementary Services:

• Full QC services with in-house qualified persons for batch release
• QP batch release and certification of GMP manufactured batches
• Regulatory support (pre-clinical, clinical, and commercial)
• Long-stay storage and replenishment of commercial drug products
• Reformulation for new dose forms or strengths

Track Record

HALIX has delivered commercial AstraZeneca COVID-19 vaccine manufacturing and serves over 75 customers in both clinical and commercial stages with a 90% retention rate. Notable partnerships include NovalGen (NVG-111 clinical supply in under seven months), Rocketvax (VIRUFLEX™ platform), and Xenikos (T-Guard® aseptic fill and finish).

Corporate Structure

HALIX is a 100% subsidiary of HAL Allergy Holding B.V., which is part of the family-owned Droege Group AG, providing long-term financial stability and investment opportunity.