Transcript Valentina Gualato, Ph.D.

COMPANY PRESENTATION
Quality and Innovation
Valentina Gualato, Ph.D.
Process Development Scientist
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
MISSION
areta international is a biotech company dedicated to the
contract development and manufacturing of biotechnology
products and cell-based medicines.
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
HEADQUARTERS – GERENZANO (VA) - ITALY
ADMINISTRATION
WAREHOUSE
QC
GMP FACILITY
R&D LABS
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
HISTORY
1999
Foundation of Areta with private capital, as a spin-off of cell biology labs of
Lepetit Research Center (subsidiary of multinational company)
2004
GMP authorization by AIFA (Italian Drug Agency) for a Cell Therapy product
for Phase I and II clinical trials
2008
GMP facility revamping: 2X surface area and 4X production capability
2012
Periodic inspection for GMP-compliance, passed with no major observations
2012
Holding F.I.S. acquires a strategic stake in Areta, to strenghten the
company’s position as the ideal partner for the development of innovative
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
WHERE WE ARE TODAY
2014
Experienced Contract Development and Manufacturing Organization, with
GMP-inspected facility, authorized to produce investigational drugs of the
following categories:
Cell-based medicines
Recombinant therapeutic proteins and monoclonal antibodies
Plasmid DNA for therapeutic vaccination
We can formulate and release the finished dosage, through in-house:
Final filling and finishing (+ lyophilization)
Chemical and microbiological analysis
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
HOLDING F.I.S.
Holding F.I.S. is a privately owned Italian holding
company. Together with its affiliates it represents a
leading example of ethics, customer focus, and
technical excellence.
F.I.S. - Fabbrica Italiana Sintetici S.p.A. and Delmar
Chemicals Inc., engaged in the development and
manufacturing of APIs and intermediates for the
worldwide pharmaceutical industry.
Holding F.I.S.
PHF SA, conceived as a "project engine" in the
pharmaceutical, nutritional and cosmetic business.
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
AREAS OF ACTIVITY
Pre-clinical development: high-quality, GMP-like material for toxicology
and non-clinical studies
Clinical development: supply for Phase I, II and III clinical trials of
Biotechnology products and Advanced Therapies
Phase
Pre-clinical
Development
stage
R&D
Clinical trials
Phase 1
Phase 2
Large scale
Phase 3
Market
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
CORE COMPETENCES
Monoclonal antibodies
Products from cells
Recombinant proteins
Tissue engineering
Cells and tissues as products
Cellular therapy
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
PLATFORMS FOR 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
RECOMBINANT PROTEIN AND ANTIBODY PRODUCTION
A complete platform for development
Bioinformatics
study on protein
properties
Choice of
suitable strain
Product
DNA codon
optimization
Gene synthesis
Scale-up in
disposable
bioreactor
Cloning in expression
vector
Set-up of
purification
strategy
Trasformation
and screening
Fermentation
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
ADVANCED THERAPIES
Regenerative medicine and cell therapy platform:
from tissue samples to potent therapeutical applications
Biopsy of
donor tissue
Cutting and enzymatic digestion
Seeding in
flasks
Expansion
Freezing of
Master Cell Bank
Thawing, expansion and
preparation of bags for
reinfusion
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
OUR EXCELLENCE IN DEVELOPMENT AND MANUFACTURING
APPLICATIONS
Here is our approach to early-stage programs:
Upstream
Process
Development
Downstream
Process
Development
Master
and Working
Cell Banks
Medium
Development
Drug
candidate
IND / IMPD
READY
Custom
Assay
Development
Regulatory
Support
Analytical
Package
We support product development through all
the steps necessary for IND filing
Phase I
Phase II
Phase III
We supply the GMP finished product for the
execution of the clinical trials
GMP
Manufacturing
Validation
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
TECHNOLOGIES IN PRODUCTION
Our manufacturing facility is exclusively based on single-use technology
Modular scale-up of production
Main advantages:
No cleaning validation
No cross-contamination
Fast turnover of batches
“Only produce the right amount that you need, when you need it”
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
FILL AND FINISH
Customized solutions for filling of liquid dosages in vials or bags
Tailored handling of small amounts for early stage clinical trials
Virtually no product losses
Labeling and packaging
Stability studies
Final filling and finishing of vials or bags
Lyophilization of final product (including lyophilization studies, if required)
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
QUALITY CONTROL AND PRODUCT ANALYSIS
Product characterization
Flow cytometry (FACS) for cell
surface markers characterization
Host Cell Proteins (HCP):
production of custom antisera
Process-related impurities
Stability studies (ICH)
-20 ± 5 °C
5 ± 3 °C
25 ± 2 °C, 60% ± 5 RH
30 ± 2 °C, 65% ± 5 RH
40 ± 2 °C, 70% ± 5 RH
Sterility and endotoxins
Other analysis
Microbial count (TAMC, TYMC)
SDS-PAGE (also 2D)
IEF, WB
HPLC
Customized assays
Potency
ELISA
Cell-based tests
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
CONTACTS
aretainternational
Via Roberto Lepetit, 34 l 21040
Gerenzano (VA), Italy l tel +39 02.96474804
fax + 39 02.96474800 l www.aretaint.com
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