Recombinants in BSL2 and use of HAL Allergy facilities

In 2009, the HAL Allergy Group has built a new facility at the Bio Science Park in Leiden, the Netherlands

This facility allows Halix to develop and manufacture therapeutic vaccines.

The state of the art facility ensures the future growth capacity of HAL Allergy. It also ensures capacity for contract manufacturing by HALIX.

Our BSL2 facility is operational since 2012. Here, HALIX manufactures recombinant proteins, antibodies and viral vectors. The HALIX BSL2 facility is a standalone unit. It has its own utilities and routing for materials and personnel.

This facility is 120 m2 large. It fits the single-use equipment needed for processes up to 500L of cell culturing scale.

There are two USP suites. They are categorized as clean room class C, and one DSP suite categorized as clean room class B/A. The DSP area is suitable for aseptic filling processes for BSL2 classified materials.

The basic equipment for upstream and downstream processing allows for processing and in-process testing.

It is our aim to use materials that are disposable. These include culture flasks, bioreactors, filtrations set-ups, bottles, and tubing. For our clients, this guarantees flexibility with regards to:

  • Choice of materials
  • Time and cost in the cleaning validation

By working in this way, we are able to secure efficiency and fulfill tight timelines.

Facility parameters and equipment

 Facilities 
Production facility   3,000 m2
Clean rooms grade C 650 m2
Clean rooms grade B/A 200 m2
BSL2 clean room grade C/B/A 120 m2
   
 Utilities 
 HVAC manufacturing  80,000 m3/h
 HVAC Cell culture  5,000 m3/h
 Purified water production  2 m3 storage - 400 L/h
 Water for injection production  2 m3 storage - 200 L/h
 Clean steam generation  2.7 bar
   
 Equipment  
Single use bioreactors   capacity up to  500 L
Pharma grade vial washer (vials)  2R, 6R, 10R, 15R, 50ml
Multipurpose autoclave  rain, mist, standard process
Dry heat steriliser  depyrogenizing at 250 ºC
Aseptic filling line  up to 20,000 vials per batch
 Freeze dryer  5.2 m2
 Cooled storage room  2- 8 ºC   200 m2