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SmB café 13 Jun '13 - Halix - Alex Huyben


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Presentation by Alex Huyben of HALIX for the Science meets Business café of 13 Jun 2013. This event was held in the BioPartner Accelerator building in Leiden.

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SmB café 13 Jun '13 - Halix - Alex Huyben

  1. 1. CMO Manufacturing & Services
  2. 2. We deliver GMP every day! That is what we do at HALIX. HALIX is a Contract Manufacturing Organization for the production of clinical batches in the biopharmaceutical industry. We offer our customers reliable GMP manufacturing and a complete portfolio of services. QUALITY Quality is our top priority. Our quality systems are embedded in all stages of operational practise. Production is performed in our state of the art cGMP facility. Routine release tests are performed in our well equipped QC laboratories. RELIABILITY We have over 50 years experience in manufacturing and release to the market of biopharmaceutical products. DEVELOPMENT Our R&D department has a proven track record of developing diagnostics and vaccines to cure allergy diseases. After successful tech transfers to our cGMP production plant, these products are produced, released and delivered on a daily basis. COMMITMENT It is our mission to ensure your product reaches its full potential. Our approach is based on providing a flexible development and manufacturing package created through close interactive partnerships with our customers.
  3. 3. Company Profile HALIX is part of the HAL Allergy Group, a Dutch biopharmaceutical company set up in Haarlem, the Netherlands over 50 years ago. In 2012 HALIX was launched as a separate business entity for contract manufacturing. We are proud to offer our clients reliable GMP manufacturing in combination with a complete portfolio of services, using an experienced manufacturing organization for sterile vaccines. This means that we are offering technology, services, R&D and the human factor. OUR MISSION STATEMENT Provide full GMP Bio-phamaceutical services to R&D companies and institutes, entailing manufacturing including complex service support to facilitate development projects up to marketing approval, at fair prices. OUR VISION Position HALIX as an experienced and stable Expert in the Bio-pharmaceutical CMO Industry, matching services with highest quality requirements, reliability, consistency and flexibility.
  4. 4. HAL Allergy starts HALIX HAL ALLERGY GROUP Founded in 1959 in Haarlem Haarlems Allergenen Laboratorium Part of the Droege International Group, Germany Relocation to BSP Leiden in 2009 Head Office – new production facilities Biopharmaceutical company manufacturing and supply of therapeutic vaccines Capabilities in R&D, QA, QC, operations, regulatory Driven by commitment, partnership, innovation Start of contract manufacturing 2011 Launch of HALIX 2012 NETHERLANDS HAL Allergy Headquarter GERMANY HAL Allergy GmbH POLAND HAL Allergy sp. z.o.o. SPAIN HAL Allergy S.L. ITALY HAL Allergy s.r.l. AUSTRIA HAL Allergie Handels-GmbH NETHERLANDS HAL Allergy Benelux B.V. NETHERLANDS HALIX B.V.
  5. 5. Manufacturing site Operational and cGMP approved since 2009 Facilities Production facility 3,000 m2 Clean rooms grade C 650 m2 Clean rooms grade B 200 m2 BSL2 clean room grade C/B 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 2R,6R, 50ml vials Multipurpose autoclave rain, mist, standard process Dry heat steriliser depyrogenising at 250 °C Aseptic filling line up to 20,000 vials per batch Freeze dryer 5.2 m2 Cooled storage room 2°- 8°C 200 m2
  6. 6. Focus of HALIX GMP manufacturing of clinical batches Technical transfer with Clients Development, upscaling Manufacturing Testing Release Logistics Recombinants – antibodies – vaccines Services Process
  7. 7. Services & Key Expertise Analytical service SDS-PAGE Immunoblot UV/VIS spectroscopy Protein Bradford Sterility Bioburden Endotoxin Visible particles Extractable volume Uniformity of dosage units Osmolality Regulatory support IMPD Dossiers Europe Analytical development HPLC methods 2D Electrophoresis ELISA Turbidity measurements CD Lyophilisation Formulation development Cycle development Scale-up Label & Pack Randomized clinical trials
  8. 8. 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 up to 500 L scale in process testing Aseptic filling Label design printing Packing for double blind randomized trial material Cold chain; storage and shipping within Europe Extraction Purification of crude extracts Ultra filtration Chromatography Formulation Sterile filtration Aseptic manual filling Aseptic automatic filling Visual inspection Freeze drying
  9. 9. Dr. P.H Flore CEO HAL Allergy Holding Biotechnology expert 20 years in veterinary and human vaccine field Alex Huybens General Manager 10 years operations experience in GMP biopharmaceutical manufacturing Dominique Mudde QA/RA Director 20 years experience in biotech manufacturing and Quality assurance Dennis Verbart Sr. developer 10 years experience of pharmaceutical development and manufacturing Marina van der Meer CMO Plant Manager BSL2 7 years CMO experience in development, tech transfers and GMP manufacturing of biopharmaceutical processes HALIX B.V. J.H. Oortweg 15-17 2333 CH Leiden Tel: 088-1959 000 Fax: 088-1959 001 Meet the HALIX Team
  10. 10. HALIX B.V. J.H. Oortweg 15-17, 2333 CH Leiden Tel: 088-1959 000 Fax: 088-1959 001