1. WP3: BAL hardware-objectives 3.1. Production bioreactors (laboratory & full scale) 3.2. Validation safety upscaled bioreactors 3.3. Evaluation sterilization & packaging large bioreactor 3.4. R&D test for technical file realization large bioreactor 3.5. Adaptation & purchase transport system bioreactor 3.6. Adaptation & purchase 2 large bioreactor incubators

2. WP3: Participants Involved parties: -Hep-Art: 9 person months -Rand S.r.l. Italy: 3rd party

3. WP3: Planning TaskStartDeadline 3.1 Bioreactor development & purchase M1M33 3.2 Safety bioreactorM5M14 3.3 Sterilization & packagingM5M14 3.4 Certification bioreactorM5M14 3.5 Transport systemM13M20 3.6 IncubatorsM13M20

4. WP3: Description of work 1st year 3.1: Production 52 large and 75 small bioreactors –Visit RanD, Italy: organizational & financial agreement for production and testing hardware –Delivery first 20 laboratory models planned in June 2012 3.2.-3.4: Safety evaluation & packaging large bioreactor: Rand in cooperation with Hep-Art

5. Wp3: Deliverables & milestone D3.1 52 large and 75 small bioreactors, M33 - D3.1.1 Manufacturing process for upscaled bioreactor; M4 - D3.1.2 75 small bioreactors; Continuous delivery until M24 - D3.1.3 52 large bioreactors; Continuous delivery until M33 D3.2 Biocompatibility data for IMPD; M14 D3.3 Sterilization and packaging evaluation report; M14 D3.4 Technical file on BAL for certification; M14 D3.5 Description of BAL transport system and optimal preservation conditions; M20 D3.6 Two incubators that facilitate the BAL during therapy ; M20 M5: Qualified manufacturing process bioreactor cultures M16

6. WP3: Dissemination Confidential reports to partners & EC Prototypes, bioreactors, incubators & transport systems to partners