areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012 IL RUOLO DELLE PICCOLE E MEDIE INDUSTRIE NELLA PROMOZIONE DELLA MEDICINA TRASLAZIONALE Quality and Innovation Dr.ssa Maria Luisa Nolli CEO
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areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
IL RUOLO DELLE PICCOLE E MEDIE INDUSTRIE
NELLA PROMOZIONE DELLA MEDICINA TRASLAZIONALE
Quality and Innovation
Dr.ssa Maria Luisa Nolli
CEO
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
INTRODUCTION – ARETA INTERNATIONAL
� 12 years of experience in contract development and
manufacturing of biologicals and cell therapy products
� GMP-authorized facility based only on single-use bioreactors
and modular scale up approach
Phase Pre-clinical Clinical trials Large scale
Development
stageR&D Phase 1 Phase 2 Phase 3 Market
Addressing the bench-to-bed need of research towards industrialization
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
BACKGROUND EXPERIENCE IN MULTINATIONALS
Expression system
Bioreactor process Assay development
Purification strategy
Bioanalytics
EPO
G-CSF
Pro-uPA
Pre-formulation
Accelerating 1st generation biologicals development through the explotation of tools
To obtain:
Quality
Reproducibility
Safety
Reliable results
Potency and stability
Clinical progress
uPA
tPA
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
Value
FundingValue
/ costs
Discovery
Public funding Industry / VC
interest
Hit tolead
Pre-clinical
Phase
I
Phase
II
Phase
III
Proofof
concept
BRIDGING BETWEEN BASIC RESEARCH AND INDUSTRY
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
Value
FundingValue
/ costs
Discovery
Public funding Industry / VC
interest
Hit tolead
Pre-clinical
Phase
I
Phase
II
Phase
III
Proofof
concept
BRIDGING BETWEEN BASIC RESEARCH AND INDUSTRY
SME
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
SINGLE-USE BIOREACTORS
An industrial approach to the scale-up, combining quality and flexibility
to support the clinical development
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
No cleaning validation
No cross-contamination
Reduced investments
Fast turnover of batches
Easy to use
Modular scale-up
Flexible
Regulatory-friendly
SINGLE-USE BIOREACTORS
High-quality and cost-effective manufacturing
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
RECOMBINANT PROTEIN AND ANTIBODY PRODUCTION
Gene synthesis
(outsourced)
DNA codon
optimizationCloning in expression
vector
Trasformation
and screening
A complete platform for development, to avoid early pitfalls
Bioinformatics
study on protein
properties
Choice of
suitable strain
FermentationSet-up of
purification
strategy
Product
up to gram amounts
(+ optional lyophilization)
Scale-up in
disposable
bioreactor
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
APPLICATIONS
New therapeutics
Biosimilars / Biobetters
Research & Dev. toolsDiagnostics
Industrial biotechnology
In vivo imaging
Quality biologicals for therapeutic/diagnostic applications or as development tools
RECOMBINANT PROTEIN AND ANTIBODY PRODUCTION
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
ADVANCED THERAPIES
Biopsy of
donor tissueCutting and enzymatic digestion Seeding in
flasksExpansion
Freezing of
Master Cell Bank
Thawing, expansion and
preparation of bags for
reinfusion
Regenerative medicine and cell therapy platform:
from tissue samples to potent therapeutical applications
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
HOSPITAL – INDUSTRY COLLABORATION
Biopsy
Expanded / functionalized cells
GMP facility
Patient
Bringing together different sets of skills and expertise
for the clinical development of Advanced Therapies
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012
HOSPITAL – BIOTECH COLLABORATION
� Good Clinical Practice
� Patient’s management
� Target indications and applications
� Clinical trial protocols
� Good Manufacturing Practice
� Scale up – industrialization
� Logistics – Supply chain
� IP management
Bringing together different sets of skills and expertise
for the clinical development of Advanced Therapies
areta international Srl l Via Roberto Lepetit, 34 l 21040 Gerenzano (VA), Italy l tel +39 02.96474804 l fax + 39 02.96474800 l www.aretaint.com Medicina Traslazionale – Roma, 14 Febbraio 2012