Dottssa Nolli

Quality and Innovation L’esperienza di una Azienda “incubata ”: opportunità e limiti Maria Luisa Nolli Chief Executive Officer

MISSION Quality and Innovation areta international is è un'azienda biotech di colture cellulari, il cui core business è rappresentato da attività di ricerca, sviluppo e produzione di biofarmaci di nuova generazione (cellule per terapia cellulare, anticorpi monoclonali, proteine ricombinanti e DNA a scopo vaccinale).

STORIA Quality and Innovation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

STORIA Quality and Innovation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

SEDI The generations of clones Gerenzano Headquarters Siena Local Unit Toscana Life Sciences Insubrias Biopark

TEAM A common goal, a shared philosophy

TEAM A common goal, a shared philosophy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

TEAM A common goal, a shared philosophy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

IL RUOLO DEI PARCHI ,[object Object],[object Object],[object Object],[object Object]

IL RUOLO DEI PARCHI: consulenza e supporto (TLS) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

TECNOLOGIA: I BIOREATTORI An innovative and customized approach

TECNOLOGIA: I BIOREATTORI An innovative and customized approach La flessibilità dei bioreattori monouso unita ad un approccio modulare alla produzione consentono ad areta international di costruire processi su misura all’interno di un ampio range di volumi, assicurando un elevato standard di purezza e qualità del prodotto finito.

TECNOLOGIA: I BIOREATTORI An innovative and customized approach ,[object Object],[object Object],[object Object],[object Object]

CASE STUDIES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CASE STUDIES Human T-cells for cancer therapy ,[object Object],[object Object],[object Object],New process for the GMP manufacturing of human TALL cells, for Phase I/II clinical trials of different types of tumours Sponsor TALL are today used in two Phase I/II clinical trials in Italy (peritoneal carcinoma) and in the USA, at MD Anderson in Houston (lymphoma)

CASE STUDIES Monoclonal antibodies for cell purging ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],The antibody is used for cell selection in a gene therapy Phase III clinical trial Sponsor

CASE STUDIES Adult stem cells for tissue regeneration Mesenchymal stem cells isolation and expansion from Bone marrow Areta is setting up GMP- compliant expansion protocols and QC analysis and release tests TCOR04: clinical study to evaluate safety and efficacy of mesenchymal stem cells implant to treat bone defect(DONATI 50686(06)-PRE21/885 del 9.10.06 ) ,[object Object],[object Object],[object Object],Sponsor Istituti Ortopedici Rizzoli

CASE STUDIES Adult stem cells for tissue regeneration Mesenchymal stem cells isolation and expansion from Adipose tissue Areta is setting up GMP-compliant expansion protocols and QC analysis and release tests ,[object Object]

CASE STUDIES Plasmid DNA for vaccination ,[object Object],[object Object],[object Object],[object Object],Areta is responsible for the production of the clinical batches and the set up of the analytical tests that will assure the product quality and consistency Authorization to start the Phase I clinical trial have been recently granted by ISS Sponsor

CASE STUDIES Non extensive tissue manipulation for regenerative medicine use ,[object Object],[object Object],[object Object],Areta has co-developed a GMP process for the treatment of the amniotic membrane The tissue is homogenized, filled into glass vials than lyophilized, ready to be used for patient treatment Sponsor

CASE STUDIES Recombinants proteins for Protein Replacement Therapy (PRT) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Sponsor

CASE STUDIES Recombinants proteins for vaccination The FP6 “ VITAL ” project with CRO Aviano ,[object Object],[object Object],[object Object],Sponsor CRO AVIANO

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