315 KB - Asebio

2nd International Symposium and Advanced Course
“Active Pharmaceutical Ingredients from Bioprocesses:
from research to industrial and regulatory issues”
APIB-2011
June 14-17, 2011
Salón de Actos “COFARES”
Complutense University of Madrid
Faculty of Pharmacy
Plaza de Ramón y Cajal, s/n
Madrid, Spain
SCIENTIFIC PROGRAMME
SCIENTIFIC WORKSHOP:
RESEARCH AND DEVELOPMENT OF NEW BIOPROCESSES AND PRODUCTS
Tuesday 14 June 2011
PL = Plenary lecture
OP = Oral presentation
IL = Invited lecture
14h00-17h30
Registration
Opening Session
17h30-17h45
Opening Session: Welcome of the Authorities
17h45-18h00
Presentation of SEBIOT
Prof. Andrés R. Alcántara, Complutense University of Madrid, Madrid, Spain
18h00-18h15
Presentation of the Congress: APIB-2011: Research, production and Quality of Active
Pharmaceutical Ingredients
Prof. Marco Terreni, University of Pavia; vice President of IBC; Pavia (Italy).
Scientific Session-01: Peptide, Protein, Vaccine and Advanced Therapy (I)
Chairman: Prof. Marco Terreni, University of Pavia, Pavia (Italy).
18h15-19:15
19h15-20h00
20h00-
OPENING LECTURE(PL1): Needs and challenges for the development and GMP production of
new biopharmaceuticals
Speaker: Vitor Lino SOUSA Areta International; Gerenzano, Varese (Italy).
IL1: Genomic technologies for identification and production of targets for vaccines and
antibacterial therapy.
Speaker: Eliora RON, Tel Aviv University; Tel Aviv (Israel):
Welcome Cocktail: wine test from Spanish producer
Wednesday 15 June 2011
Scientific Session-02: Peptide, Protein, Vaccine and Advanced Therapy (II)
Chairman: Prof Flavia Marinelli; University of Insubria (Varese) Italy
9h30-10h30
10h.30-10.50
PL2: Synthetic Carbohydrate Vaccines.
Speaker: . Peter H. SEEBERGER Max-Planck-Institute of Colloids and Interfaces. Potsdam-Golm.
(Germany)
OP1 Biotechnological approach for the rational design of new vaccines for TBC. Presentation of
VATUB project.
Speaker: Marco TERRENI, University of Pavia, Pavia (Italy)
10h50-11h30 Coffee Break
11h30-12h00
OP2: Biotechnology applications of recombinant DNA
Speaker: Fedederico NININO, Università degli Studi di Udine. Udine (Italy)
12h00-12h30 OP3: Production of synthetic peptides as immunological probes for in vitro diagnostic assays
Speaker: Paolo ROVERO; University of Florence, Sesto Fiorentino, Firenze (Italy)
12.h30-13h15 IL2: Plant thymidine kinases as suicide genes for anti-cancer therapy”.
Speaker: Jure PISKUR, Lund University, Lund (Sweden)
13h15-14h30:
Lunch
14h30-15h30:
POSTERS
Scientific Session-03: New and improved biocatalyst and enzymatic bioprocesses (I).
Chairman: Prof. María J. HERNÁIZ, Complutense University of Madrid, Madrid, Spain.
15h30-16h45
16h45-17h15
17h15-17h45
17h45
IL3: Pichia pastoris as cell factory to produce recombinant proteins. Production and application
of Rhizopu oryzae lipase.
Speaker: Francisco VALERO; Autonoma University of Barcelona, Barcelona (Spain).
OP4: Enzymatic synthesis of Vidarabine.
Speaker: Immacolata SERRA, University of Pavia, Pavia (Italy).
OP5: Preparation of (S)-benzoins using the non-conventional yeast Pichia glucozyma.
Speaker: M.Caterina FRAGNELLI, University of Milan, (Italy)
Closure of session
18h00-19h30 SEBIOT GENERAL ASSEMBLY
20h00
Guided Visit to Madrid and Social Dinner
Thursday 16 June 2011
Scientific Session-04: New and improved biocatalyst and enzymatic bioprocesses (II).
Chairman: Prof. Paolo ROVERO; University of Florence, Sesto Fiorentino (Firenze), Italy
09h30-10h15
IL4: Enzymologists in wonderland: new biotech applications from evolved D-amino acid oxidases.
Speaker: Prof. Loredano POLLEGIONI; University of Insubria, Varese, (Italy).
10h15-110h45 OP6: Immobilised L-Amino acid acylase and N-Acetyl amino acid racemase for L-methionine
production.
Speaker: Ulrich E. GIESECKE, W42 Consulting GmbH, Penzberg (Germany).
10h45-11h15 OP7: Chemoenzymatic synthesis of unsymmetrical benzoins, useful drug intermediates, via
dynamic kinetic resolution.
Speaker: Pilar HOYOS, Complutense University of Madrid, Madrid (Spain).
11h15-11h45 Coffee Break
11h45-12h15
12h15-12h45
12h45-13h15
OP8: PHB depolymerases from Streptomyces for production of high added value compounds.
Speaker: Miguel ARROYO, Complutense University of Madrid, Spain.
OP9: Modulating resveratrol solubility and surfactant activity by enzymatic glucosylation.
Speaker: Pamela TORRES, Instituto de Catálisis y Petroleoquímica (CSIC) Madrid, (Spain).
OP10: Chemoenzymatic synthesis of high quality testosterone.
Speaker: Riccardo MOTTERLE, F.I.S. Fabbrica Italiana Sintetici S.p.A., Vicenza, (Italy).
13h15-14h30:
Lunch
14h30-15h30:
POSTERS
Scientific Session-05: Biosynthesis and semi-synthesis of APIs and nutraceutics
Chairman: Prof. Francisco VALERO; Autonoma University of Barcelona, Spain.
15h30-16h30
16h30-17h00
17h00-17h30
17h30-18h00
18h00
PL3: Marine Biodiversity & Biotechnology as source of innovative anticancer drugs. The
experience of PharmaMar.
Speaker: Fernando DE LA CALLE, PharmaMar, S.A. Colmenar Viejo, Madrid (Spain):
OP11: Modulation of complex composition in fermentative industrial production of glycopeptides.
Speaker: Flavia MARINELLI, University of Insubria; Varese; (Italy)
OP12: Enzymatic modification of glycolipopeptides.
Speaker: Francesco Molinari; Università degli Studi di Milano; Milano (Italy)
OP13: Improved method for the extraction of licopene from tomato processing waste:
development and scale up.
Speaker: M. Argnani, Biosphere SpA, Bertinoro (Forlì Cesena), Italy.
CLOSING OF THE SYMPOSIUM
Friday 17-June 2011
ADVANCED COURSE:
INDUSTRIAL BIOPROCESSES AND QUALITY OF ACTIVE INGREDIENTS
09h30-10h15 Quality of biotechnological products and biosimilars.
Dr. Sol Ruiz; Spanish agency of medicinal products-AEMPS; Madrid; (Spain)
10h15-11h00 Second generation vaccines: the long way to the market.
Dr. Carmen VELA; Ingenasa; Madrid (Spain).
11h00-11h30 Coffee Break
11h30-12h10 Registration of biological medicinal products in EU: a regulatory perspective.
Dr. Carla Martino, European Medicinal Agency; London (England).
12h10-12h50 Relevant GMP aspects of the industrial manufacture of biotechnology products from the
inspector’s perspective.
Dr. Manuel IBARRA LORENTE, Spanish agency of medicinal products (AEMPS) Madrid; (Spain)
12h50-13h30 The Ph. Eur and the monographs for fermentation products, peptides and biologicals – general
concepts and practical examples.
Dr. Helene BRUGUERA, EDQM, Council of Europe; Strasbourg; (France)
13h30-14h45 Lunch
14h45 -15h15 Basic procedures and controls for fermentation processes.
Prof. Francesco MOLINARI (Università degli Studi di Milano, Milan (Italy)
15h15-16h00 Biotransformation and quality of Active Pharmaceutical Ingredient.
Prof. Marco TERRENI; University of Pavia; Pavia, (Italy)
16h00-16h30 Coffee Break
16h30-17h10 GMP and Quality Risk Management Process for multi product on fermentation and
microfiltration equipment Case study from class B1 product to other products.
Dr. Fulvio CARLOTTI; Gnosis S.p.a; Desio; Monza Brianza (Italy)
17h10-17h40 Quality problems for APIs used in essential medicines for developing countries: role of WHO and
its pre-qualification programme.
Corinne POUGET; Consultant, Castres; (France)
17h40
Closure of the Course