1st International Symposium and Advanced Course

Active Pharmaceutical Ingredients from Bioprocesses: from research to industrial and regulatory issues
APIB-2009
June 3-6, 2009 University of Pavia Via Strada Nuova 65 Pavia, Italy

Master di 2 livello in Progettazione e Sviluppo dei Farmaci

Biotechnology and industrial production of APIs The technology for Active Pharmaceutical Ingredients (APIs) production is improving day by day with the aim of achieving new products and new processes which are more convenient in terms of costs and yields. In this context, biotechnology plays a crucial role. The use of fermentation processes as well as other bioprocesses is becoming increasingly common and appealing. Biotechnology is also being applied nowadays in the early stages of pharmaceutical research, from the discovery to the synthesis of new lead compounds, in a view to facilitate the preparation of small libraries or to develop new drugs. A new synthetic technology suitable for a rapid industrial development may be very attractive and useful for the preparation of new and old products. Also regulatory requirements should take into account new technological tools to ensure the control of bioprocesses, particularly if manipulated micro-organisms or catalysts obtained by new protein engineering approaches are used. In fact, medicines that do not meet official standards for quality and purity may result in serious health implications including treatment failure, adverse effects, increased morbidity, mortality, development of drug resistance, and wasted resources. What is the aim of the meeting? In order to ensure high process performances as well as adequate purity and quality control in APIs production, particularly when carried out by bioprocesses, Regulatory Authorities should be strictly connected with research, industrial production and quality assurance. EDQM, in collaboration with the University of Pavia and the Italian Biocatalysis Center (IBIOCAT), is organising a meeting addressed to industries, universities, research centres and regulatory authorities, for a reciprocal exchange of information and competences. This meeting aims to provide an overview on the recent advancements in the field of the biotechnological R&D as well as information, rules and technical aspects that should be considered for quality control in the bio-production of APIs. Preliminary Program Speakers will be from universities and research centres, companies and European and National regulatory authorities. Participants from the following areas or expertise are expected to attend the meeting: Applied research Development of industrial bioprocesses Industrial production of Active Ingredients Quality of Active Ingredients Regulatory requirements for industrial bioprocesses

The meeting will be divided into two parts: a scientific workshop and an advanced course. 1. Scientific Workshop: Research and development of new bioprocesses and products June 3-4, 2009 The first two days will be devoted to the elucidation (by oral presentations and a poster session) of recent scientific improvements in the field of biotechnology applied to the production of drugs. The following topics will be discussed: -Improved strains and improved fermentation processes Improved micro-organisms New fermentation processes and products -Improved biocatalysts and enzymatic bioprocesses Enzymes improved by protein engineering New enzymatic processes - Novel bioprocesses for the preparation of nutra/nutriceutical ingredients 2. Advanced course: Industrial bioprocesses and quality of active ingredients June 5-6, 2009 The second section of the meeting will include selected lectures with the aim of elucidate explaining different aspects of the industrial production of drugs. Particular attention will be devoted to products prepared by fermentation or enzymatic bioprocesses, including all the technical and regulatory issues that should be considered to obtain controlled pure products. The following topics will be discussed: Technical issues Production of antibiotics, chemical active ingredients and recombinant proteins by fermentation processes Development of industrial enzymatic processes based on proteins engineering Biosynthesis of nutra/nutriceuticals Regulatory Issues Quality of active ingredients and fermentation products Impact of bioprocesses on the quality of active ingredients Control of fermentation processes Certificate of Suitability at the European Pharmacopoeia and revisions Regulatory aspects in nutra/nutriceuticals Sterile products, regulatory aspects and technical controls GMP for APIs manufactured by fermentation EDQM and EDQM inspection program

Call for Abstracts (Oral presentations and Posters) Deadline for abstract submission: March 2, 2009 Decision for abstract acceptance: March 16, 2009 on line submission: http://www.aidic.it/apib2009/abstractsubmission.html For information, please contact: Scientific Secretariat For scientific information, please contact: Prof. Marco Terreni, markt@ibiocat.eu, tel: +39 0382 987 265 Registration Registration opening: January 15, 2009 Deadline for registration: April 20, 2009 (without supplement) For information, please contact: Organisation Secretariat Contacts Scientific Secretariat Manuela Licciardello AIDIC (Italian Association of Chemical Engineering) Conference Department Via Giuseppe Colombo 81 A, I-20133 Milano, Italy e-mail: APIB-2009@aidic.it Tel. +39 02 70608276; Fax. +39 02 59610042 Organisation Secretariat Marta Daffara (Pragma Congressi) Corso Mazzini 9, I-27100 Pavia, Italy e-mail: APIB-2009@pragmacongressi.it Tel. +39 0382 39879 University of Pavia Prof. Maurizia Dossena e-mail: maurizia.dossena@unipv.it Tel. +39 0382 986442 IBIOCAT Dr. Teodora Bavaro e-mail: dorab@ibiocat.eu Tel. +39 0382 987876 EDQM Ms Caroline Larsen Le Tarnec e-mail: francine.baumgarthen@edqm.eu Tel. +33 (0)3 88 41 28 24 Organisation EDQM/Council of Europe (Strasbourg, France) University of Pavia (Pavia, Italy) IBIOCAT (Italian Biocatalysis Center, Pavia, Italy) Pragma Congressi (Pavia, Italy) AIDIC (Italian Association of Chemical Engineering; Milano, Italy)

Scientific Committee Prof. Marco Terreni (IBIOCAT; University of Pavia; Pavia, Italy) Prof. Francesco Molinari (AIBB; University of Milan; Milan, Italy) Prof. Andres Alcantara (University Complutense of Madrid; Madrid, Spain) Dr. Aurelio Viglia (AIDIC; IBIOCAT; Milan, Italy) Dr. Helen Bruguera (EDQM/Council of Europe; Strasbourg, France) Dr. Fulvio Carlotti (Pierrel S.p.a.; Capua, Italy) Prof. Sergio Riva (CNR; Milan, Italy) Prof. Stefano Servi (AIBB; Polytechnic of Milan; Milan, Italy) Prof. Giuseppe Pagani (University of Pavia; Pavia, Italy) Prof. Flavia Marinelli (University of Insubria; Varese, Italy) Prof. Paolo Manitto (IBIOCAT; University of Milan; Milan, Italy) Organizing Committee Ms Caroline Larsen Le Tarnec (EDQM/Council of Europe; Strasbourg, France) Prof. Maurizia Dossena (University of Pavia, Italy) Prof. Ornella Azzolina (University of Pavia, Italy) Dr. Marta Daffara (Pragma Congressi, Pavia, Italy) Dr. Daniela Ubiali (University of Pavia, Italy) Dr. Teodora Bavaro (University of Pavia, Italy) Dr. Immacolata Serra (University of Pavia, Italy) Partners AIBB (Italian Association of Biocatalysis and Bioseparations) CPA (Chemical and Pharmaceutical Association) SCI (Italian Chemical Society, Medicinal Chemistry Division) AIDIC (Italian Association of Chemical Engineering) SEBIOT (Spanish Society of Biotechnology)