Hämosan ® Life Science Services GmbH A-8262 Ilz, Neudorf 41 Tel. +43 (0) 3385/8117 mail:...

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 LSS:Life Science Services

Worldwide services for Pharma and Biotech

Hämosan is:

Hämosan MmQ:Management mit Qualität

Coaching

Consulting

Training


MmQCoaching – Consulting – Training

• Strategy• Strategic HRM• Leadership• Managing Creativity Innovation Development


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


Our core competence inHämosan LSS:

Safety of Blood Products


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…


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)


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


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


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)


Cleanrooms for training


Contact:

Herwig Reichl

Hämosan LSS GmbHNeudorf 41A-8262 Ilz, Austria

[email protected]

Hämosan ® Life Science Services GmbH A-8262 Ilz, Neudorf 41 Tel. +43 (0) 3385/8117 mail:...

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