Good design practices for an integrated containment and production system for advanced therapies

Author:

Zanini Cristina12ORCID,Severina Franco2ORCID,Lando Giovanni2ORCID,Fanizza Carlotta1ORCID,Cesana Eugenio2ORCID,Desidera Davide2ORCID,Bonifacio Marco12ORCID

Affiliation:

1. Advanced Therapies BioAir SPA Department, Molecular Biotechnology CentreUniversity of TurinTurin Italy

2. Advanced Therapies DepartmentBioAir SPAPero Italy

Publisher

Wiley

Subject

Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Reference29 articles.

1. Agalloco J. Akers J. &Madse R.(2004).Pharmaceutical Technology Aseptic Processing: A Review of Current Industry Practice.

2. Current practices in the use of media fills in the validation of aseptic processing;Agalloco J.;Journal of Parenteral Science and Technology,1987

3. Basics of sterile compounding: Barrier isolator technologies in aseptic processing;Akers M. J.;International Journal of Pharmaceutical Compounding,2015

4. Isolators selection, design, decontamination, and validation;Barbu N.;Pharmaceutical Engineering,2014

5. Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy

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