Quality and Innovationold.iss.it/binary/iatr/cont/PiccoleMedie_Industrie_Nolli.pdf · Medicina...

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


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


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


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


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


SINGLE-USE BIOREACTORS

An industrial approach to the scale-up, combining quality and flexibility

to support the clinical development


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


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


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


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


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


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


THANK YOU FOR YOUR ATTENTION!

areta international

Via Roberto Lepetit, 34 l 21040

Gerenzano (VA), Italy l tel +39 02.96474804

fax + 39 02.96474800 l www.aretaint.com

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