Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners world-wide.
Exclusive, third-party manufacturing services are offered by the Chemical Division for High Potency Active Ingredients (HPAIs) and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India
“To provide excellent services, helping our partners to achieve their core business objectives“
“To be a leading company in distinctive chemical and biological API products and services”
"Fostering Value through Innovation"
Christian Suà CFO
Andrea Tam CCO
Claudio Pozzoli CSO
Fausto Vellani COO
Clarissa Gobetti Director Quality Assurance
Vincenzo Ursino Director of Project Management Office
Annalisa Miracca M&S Director Chemical Division
Christof Schickli Production Director
Kandid Oehen Director Regulatory Affairs
Massimo Bortolin Director Quality Control
Raffaella Coppolecchia Director Biological R&D
Massimo Bossi Engineering Director
Paolo Caldini Director Supply Chain
Holds a Master Degree in Organic Chemistry from the Swiss Federal Institute of Technology (ETHZ) in Zürich (1985) and a Ph.D. in Natural Sciences from the ETHZ in 1989.
After different experiences in Sales and Marketing positions, he joined the Helsinn Chemical Operations in 1999 for third party chemical manufacturing CMO activities of the Helsinn group.
In 2004 became Head of Business Development for the CMO activities of the Helsinn group.
He joined CERBIOS as of January 1st, 2009 as CEO with the goal to restructure the company organization, the product and service portfolio through organic and inorganic growth and renew completely the company image.
Holds a Master’s degree in Business Administration/economics from the University of St. Gallen, Switzerland (HSG).
From 1994 to 2002, he gained international managerial experience in Finance, Controlling, IT, Legal and Human Resources in various multinational companies such as NCR and General Electric.
He joined CERBIOS in 2002 as CFO.
Teacher in Economics at the University of Applied Sciences of southern Switzerland (SUPSI).
Mr. Tam holds a Degree in Industrial Chemistry from the Università degli Studi di Milano (1998).
After a period as Research Associate at the University, he joined the Italian subsidiary of Mitsubishi Chemical Corporation Group as R&D scientist in 2000, achieving the position of R&D Manager.
In 2005, he joined Antibioticos Marketing & Sales Department, managing special projects and custom projects with key accounts.
From 2007 to 2011, with Recordati S.p.A. as Business Development Manager in the Pharmaceutical Chemicals' Division with world-wide responsibility, and from 2011 to 2012 as BD Manager at Farmabios.
Andrea Tam joined CERBIOS in 2012 as Director of Business Development.
In 2014 he was promoted to Chief Commercial Officer (CCO), taking full responsibility for both Business Development and Marketing&Sales (Chemical and Biological Divisions).
Holds a degree in Organic Chemistry from the Università degli Studi di Milano and has been active in the pharmaceutical industry since 1989.
After a short period at Boehringer Ingelheim as a Scientist in the Medicinal Chemistry Centre in Milano, he moved to the Zambon Group in 1992 as Senior Scientist in the G. Zambon Research Centre in Bresso (near Milano).
From 1997 to 2001 he was Custom Synthesis and Cost Calculation Manager at Norpharma.
Production Manager in Poli Industria Chimica in 2001, he became R&D Director in the same year with Sicor.
From 2003 to 2015 at Farmabios as R&D Director, he was also Plant Manager during the period 2003-2007.
Claudio joined CERBIOS on October 1st, 2015 as Director R&D Chemical Division.
In january 2017 he was promoted to Chief Scientific Officer (CSO), taking full responsibility for both Chemical and Biological R&D Divisions.
He is author of several patents in the field of Organic Chemistry.
Holds a degree in Natural Sciences (1991) from the Swiss Federal Institute of Technology in Zürich (ETHZ) and a Ph.D. in Biochemistry/Molecular Biology (1995).
From 1995 to 2008 he was active in different positions in Technical Operations of Novartis Locarno, Basel and Stein.
He joined CERBIOS as of July 1st, 2008 as Project Manager.
Since November 2008 he operates as Chief Operating Officer leading the supply chain of the company (Production Chemical and Biological, QC, Engineering and Logistic).
Holds a Master Degree in Chemistry from the University of Insubria in Como (1998).
Active in the pharmaceutical industry since 1999, both in Quality Control (Patheon Italia, Monza) and in Quality Assurance (Jetpharma SA and CERBIOS).
She joined CERBIOS in 2006 as Quality Assurance Manager.
Since 2008 she has been Director of Quality Assurance and Qualified Person (Technical Responsible Person according to the Swissmedic Ordinance OAM 812.212.1).
In 2011, she took over responsibility for both the Quality Assurance group and the Regulatory Affairs group as well as becoming Head of the CERBIOS group Quality Assurance, handling inspections by authorities (FDA).
Holds a degree in Architecture (Interior Design), (1993) from Iuav - Venezia
After several years as Interior Designer and Project Manager, between 1997 and 1999 Vincenzo worked for Gucci USA as Project Manager and Ermenegildo Zegna Italy as Co-Director of Worldwide Store Planning in Milan.
From 2003 to 2009 he was entrepreneur and CEO of a Group of Companies in diversified business fields.
His teaching activity in Project Management, Strategic Planning and Business Growth started in 2005 at the University of Perugia (Italy) – Department of Economics.
He joined CERBIOS May 2016 as Director of the newly created Project Management Office, in charge of the supervision, coordination and prioritization of projects according to customer and company needs.
- Since 2009: owner of an independent business management consultant company
- Since 2009: Project Management Teacher at Centro Studi Bancari in Vezia/Lugano.
- Since 2016: President of ASIO (Swiss Italian Association for Organization and Management) and professor of its Faculty.
Holds a Master Degree in Chemistry from the Università degli Studi di Pavia.
She is has been active in the pharmaceutical and chemical industry since 1997.
After a short period spent in QC laboratories of different companies, she started her experience in Marketing & Sales in 1997 when she joined the Italian subsidiary of the American multinational company Sigma–Aldrich, where she also took responsibility for the import and sales of controlled substances.
Her career continued between 2001 and 2014 with Farmabios S.p.a. in the Marketing & Sales Department in charge of sales in several countries.
She joined CERBIOS on October 1st, 2014 as Marketing& Sales Chemical Director.
Holds a degree in Organic Chemistry from the Swiss Federal Institute of Technology in Zürich (ETHZ) 1986 and a Ph.D. in Natural Sciences from the ETHZ (1990).
After a Research Fellowship at the Australian National University (Canberra), he joined CERBIOS in 1992 as Team Leader in R&D.
In 1996 he took over responsibility for the Chemical Production as Director.
Since 2013, he has been in charge of all production units of CERBIOS (Chemical and Biological)
Holds a degree in Chemistry from the University of applied science in Basel (1982).
He started his career in the research laboratories at Ciba-Geigy and Hoffmann-La Roche in Basel. He was active in the development of organic electrochemical syntheses, as well as of galenicals of vitamins and carotenoids for feed and food applications.
In the nineties, he moved to the Italian speaking part of Switzerland as technical director for the Lugano branch of Togal-Werk and was active in the pharmaceutical manufacturing of tablets and liquid preparations.
In 1995, he joined CERBIOS as Director of Regulatory Affairs and the organization and management of the relevant documentation required for the quality system . Today he operates as Regulatory Affairs Director at group level.
Massimo Bortolin holds a degree in Chemistry from the Swiss Federal Institute of Technology in Zürich (ETHZ) gained in 1991.
He joined CERBIOS the same year as Manager in the analytical R&D laboratory.
From 1995 to 2008 he was Quality Control Director of the Chemical Laboratory of CERBIOS.
In 2008, he was promoted QC Director and took full responsibility for both the Chemical and Microbiological Laboratories.
She holds a Ph.D in Genetic Sciences, carried out at the University of Pavia, Italy, and at the Emory University School of Medicine, Atlanta USA on B.subtilis. She then conducted postdoctoral studies on yeast genetics at the Biozentrum Basel, Switzerland from 1991 to 1993.
She joined CERBIOS in 1993 as a research scientist in microbiology, genetics and CHO cell biology.
Since 1999, as Director of the Biological R&D Department, she leads the development and transfer activities related to manufacturing and control of recombinant proteins and probiotic biopharmaceuticals.
Raffaella Coppolecchia is author of patents and peer-reviewed publications in the field of molecular and cell biology.
Massimo Bossi holds a degree in natural sciences and a Ph.D. in Biochemistry from the Swiss Federal Institute of Technology in Zürich (ETHZ) and two Post Doctorates.
He joined Cerbios-Pharma SA in 1993 as a member of the Research and Development group, moved to the Engineering group as validation manager in 1999 and since 2008 is Head of the Engineering Department.
His achievements include the revamping of chemical and biological plants and realization of new production lines together with networking and sharing of process related data.
His area of responsibility covers a wide field, such as mechanical, electrical and ventilation, and he liaises closely with quality assurance.
Has a commercial background with specialization diplomas in Strategic Purchasing and Supply Chain Management.
He started his pharmaceutical experience in 1996 at a former Swiss subsidiary of the Boehringer-Ingelheim Group, where he extended his international experience , gaining leadership of global projects. At the end of 2002, he was nominated to lead the Strategic Purchasing Department of the Swiss subsidiary.
In 2009 he joined the AENOVA Group, managing the Strategic Procurement Department at Corporate level. His career continued in 2011 when he was made responsible for Sstrategic Procurement at LONZA’s Headquarters, Basel.
Mr. Caldini joined Cerbios-Pharma SA in 2013 as Supply Chain Director.
Regularly inspected by the FDA, Cerbios' has an excellent track record since 2000 without any 483 issuance.
This is the confirmation that our cGMP system is state-of-the-art and compliant with the most recent guidelines and validates our strategy of having an excellent system in place serving our partners.
The last general GMP inspection covered all areas of the organisation and systems involved in the production of Active Pharmaceutical Ingredients.
Cerbios’ strategy is to pursue excellence and innovation at all levels, from manufacturing production units to quality systems and customer care.
HSE Management System
CERBIOS has developed an outstanding Health, Safety and Environment (HSE) Management System designed to ensure that all aspects of HSE are managed efficiently and to promote continual improvement within the company operations.
Our HSE objectives are:
- prevention of accidents, injury and pollution
- achievement of a world-class HSE performance
This can only be obtained with design quality, risk assessment and continuous training followed by a dedicated Safety Engineer.
Cerbios’ group State-of-the-Art Quality System for International Supply
The company's Quality Policy is aimed at assuring the conformity of the products through a strict and efficient quality system. The basis of our system is a constant and careful review of all the company’s activities, striving for continuous improvement.
Our history of excellent track record demonstrates that continuous investment in personnel training and in system improvement has provided the expected results.
Successful audits performed by our Partners and Authorities from highly regulated markets (e.g. EU, USA, Japan) are a confirmation of our well established and reliable Quality System.
Cerbios is regularly audited by its partners and health authorities
SwissMedic : every two years providing cGMP certificate (recognized by EMA). Last inspection 12/2015
US-FDA : for products sold in the USA or under registration. Last inspections 02/2014
PMDA : Cerbios site has granted Accreditation since 2006, last renewal in 2015