CMO Manufacturing & Services

We deliver GMP every day!That is what we do at HALIX. HALIX is a Contract Manufacturing Organizationfor the production of clinical batches in the biopharmaceutical industry. Weoffer our customers reliable GMP manufacturing and a complete portfolio ofservices.

QUALITYQuality is our top priority. Our quality systems are embedded in all stages ofoperational practise. Production is performed in our state of the art cGMPfacility. Routine release tests are performed in our well equipped QClaboratories.

RELIABILITYWe have over 50 years experience in manufacturing and release to themarket of biopharmaceutical products.

DEVELOPMENTOur R&D department has a proven track record of developingdiagnostics and vaccines to cure allergy diseases. After successful techtransfers to our cGMP production plant, these products are produced,released and delivered on a daily basis.

COMMITMENTIt is our mission to ensure your product reaches its full potential.Our approach is based on providing a flexible developmentand manufacturing package created through close interactivepartnerships with our customers.

Company Profile

HALIX is part of the HAL Allergy Group, a Dutchbiopharmaceutical company set up in Haarlem, theNetherlands over 50 years ago. In 2012 HALIX waslaunched as a separate business entity for contractmanufacturing.

We are proud to offer our clients reliable GMPmanufacturing in combination with a completeportfolio of services, using an experiencedmanufacturing organization for sterile vaccines. Thismeans that we are offering technology, services,R&D and the human factor.

OUR MISSION STATEMENT

Provide full GMP Bio-phamaceutical services to R&Dcompanies and institutes, entailing manufacturingincluding complex service support to facilitatedevelopment projects up to marketing approval, atfair prices.

OUR VISION

Position HALIX as an experienced and stable Expertin the Bio-pharmaceutical CMO Industry, matchingservices with highest quality requirements, reliability,consistency and flexibility.

HAL Allergy starts HALIXHAL ALLERGY GROUP

Founded in 1959 in HaarlemHaarlems Allergenen Laboratorium

Part of theDroege International Group, Germany

Relocation to BSP Leiden in 2009Head Office – new production facilities

Biopharmaceutical companymanufacturing and supply of therapeuticvaccines

Capabilities inR&D, QA, QC, operations, regulatory

Driven bycommitment, partnership,innovation

Start of contract manufacturing2011

Launch of HALIX 2012

NETHERLANDS

HAL AllergyHeadquarter

GERMANY

HAL AllergyGmbH

POLAND

HAL Allergysp. z.o.o.

SPAIN

HAL AllergyS.L.

ITALY

HAL Allergys.r.l.

AUSTRIA

HAL AllergieHandels-GmbH

NETHERLANDS

HAL AllergyBenelux B.V.

NETHERLANDS

HALIX B.V.

Manufacturing site

Operational and cGMP approved since 2009

FacilitiesProduction facility 3,000 m2

Clean rooms grade C 650 m2

Clean rooms grade B 200 m2

BSL2 clean room grade C/B 120 m2

UtilitiesHVAC manufacturing 80,000 m3/hHVAC Cell culture 5,000 m3/hPurified water production 2 m3 storage - 400 L/h Water for injection production 2 m3 storage - 200 L/hClean steam generation 2.7 bar

EquipmentSingle use bioreactors capacity up to 500 LPharma grade vial washer 2R,6R, 50ml vialsMultipurpose autoclave rain, mist, standard

processDry heat steriliser depyrogenising at

250 °CAseptic filling line up to 20,000 vials perbatchFreeze dryer 5.2 m2

Cooled storage room 2°- 8°C 200 m2

Focus of HALIXGMP manufacturing of clinical batches

Technical transfer with Clients

Development, upscaling

Manufacturing

Testing

Release

Logistics

Recombinants – antibodies – vaccines

Services Process

Services & Key Expertise

Analytical serviceSDS-PAGEImmunoblotUV/VIS spectroscopy Protein BradfordSterilityBioburdenEndotoxinVisible particlesExtractable volumeUniformity of dosageunitsOsmolality

Regulatory supportIMPDDossiersEurope

Analytical developmentHPLC methods 2D ElectrophoresisELISA Turbidity measurements CD

LyophilisationFormulationdevelopmentCycle development Scale-up

Label & PackRandomized clinicaltrials

Manufacturing capabilities

USP DSP FORMULATION STERILE FILLING LYOPHILIZE LABEL & PACK STORAGE & DISTRIBUTION

BSL2 Grade Class C/B/A Pharmaceutical clean AreaClean Room Class C/B/A

Recombinant protein production

Single use Bioreactors upto 500 L scale

in process testing

Aseptic filling

Label design printing

Packing for double blindrandomized trial material

Cold chain; storage andshipping within Europe

Extraction

Purification ofcrude extracts

Ultra filtration

Chromatography

Formulation

Sterile filtration

Aseptic manual filling

Aseptic automatic filling

Visual inspection

Freeze drying

Dr. P.H FloreCEO HAL Allergy HoldingBiotechnology expert20 years in veterinary and human vaccine field

Alex HuybensGeneral Manager10 years operations experience in GMP biopharmaceutical manufacturing

Dominique MuddeQA/RA Director20 years experience in biotech manufacturing and Qualityassurance

Dennis VerbartSr. developer10 years experience of pharmaceutical development and manufacturing

Marina van der MeerCMO Plant Manager BSL2 7 years CMO experience in development, tech transfers and GMP manufacturing of biopharmaceuticalprocesses

HALIX B.V.J.H. Oortweg 15-17

2333 CH LeidenTel: 088-1959 000

Fax: 088-1959 001www.halix.nlinfo@halix.nl

Meet the HALIX Team

HALIX B.V.J.H. Oortweg 15-17, 2333 CH LeidenTel: 088-1959 000 Fax: 088-1959 001www.halix.nl