Upload
lewis-higgins
View
215
Download
1
Tags:
Embed Size (px)
Citation preview
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
Trainings and much more...
Herwig ReichlHämosan Life Science Services GmbH
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
Hämosan LSS:Life Science Services
Worldwide services for Pharma and Biotech
Hämosan is:
Hämosan MmQ:Management mit Qualität
Coaching
Consulting
Training
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
MmQCoaching – Consulting – Training
• Strategy• Strategic HRM• Leadership• Managing Creativity Innovation Development
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
HÄMOSAN LSS Viral Safety – QM – Cleanroom
• Protein purification• Viral & prion safety• GMP expertise• Cleanrooms for Training• QM for SMEs, pharmacies etc.
– ISO 9001– ISO 13485
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
Our core competence inHämosan LSS:
Safety of Blood Products
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
The Need for Safer Products
• Long history of transmission of bacterial, viral and recently also:
prion diseases via blood-derived therapeutics, vaccines, food etc.:
Listeria, Salmonella, SV40, HIV, Hepatitis, Parvo B19, vCJD…
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
3 ways to improve safety
• Screening – is not enough (1-2 10log reduction):
• “diagnostic window“• unknown viruses
• Testing of end product (1-2 10log):– lacks sensitivity; unknown viruses
• Removal and inactivation steps in manufacturing processes! (> 10 10log)
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
Validated removal and inactivation steps are required for registration
by• FDA (USA)
• EMEA (EU)
• and all other national authorities
Consensus:
Several (>2) robust steps capable of removing > 4 logs of infectivity each;
Validated with several relevant virus models
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
How is it done?
1. Identify possible removal steps in the existing process – if needed, add dedicated ones!
2. Scale down the steps and validate scale-down!
3. Perform validation experiments in safety labs by adding (“spiking“) infectivity and analysing all fractions for it
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
Our experience in the field:
• Scale down validation for all COHN plasma fractionation steps of client
• Coordinating 4 EU funded research projects focusing on TSE validation
• 160 virus and prion validation studies for various clients, mainly in blood industry
• QM and GMP consultancy mainly in (hospital) pharmacies, biotech industry
• Cleanrooms for practical training (“hands on“!) and pilot scale production (for clinical trials)
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
Cleanrooms for training
Hämosan® Life Science Services GmbH A-8262 Ilz, Neudorf 41Tel. +43 (0) 3385/8117 mail: [email protected] www.haemosan.com
Contact:
Herwig Reichl
Hämosan LSS GmbHNeudorf 41A-8262 Ilz, Austria