CELL THERAPY

 

NestaCell® - TRADEMARK - PATENT GRANTED IN THE USA AND EUROPE

The cells are handled in a controlled “ISO5” environment surrounded by an ISO7/resting or ISO8 controlled environment in operation.

Cellavita's facilities and Good Manufacturing Practices for Advanced Cell Therapy products follow the regulations of RDC 441/2011, RDC 11/2009 and part of RDC 55/2015, in addition to the specific requirements of RDC No. 214, of February 07th, 2018 related to the Cell Processing Center.

The quality parameters of the product and production follow the regulations of Anvisa and Brazilian Pharmacopoeia "Food Drug Administration" - FDA, International Cellular Therapy Society, "European Medicines Agency" - EMA.

Other Cellavita facilities:

- Quality control

- Stock

- Cryopreservation room

- Offices

- Quality assurance

- Waste washing and disposal room

- Stock

- Reception room for materials and biological materials

CLINICAL STUDIES APPROVED

PROJECT APPROVED AT FINEP

PRODUCTIVE PLANT EXPANSION 2019/2020

Expansion of the Manufacturing Plant for large-scale production of Advanced Therapy Products.

• The new production plant is located at Rua Duilio Beltramini, 7427 - Valinhos, São Paulo

• Expansion works started in January 2020

• The cells are handled in a controlled “ISO5” environment surrounded by an ISO7/resting or ISO8 controlled environment in operation

• The quality parameters of the product and production follow the regulations of Anvisa, Brazilian Pharmacopoeia "Food Drug Administration" - FDA, International Society of Cellular Therapy "European Medicines Agency" - EMA.

New Factory Cellavita in Valinhos/SP - 2020

Cellavita - 2020 - Todos os direitos reservados