Challenges within a CMO Purification Process A Case Study of Crossflow Micro- and Ultrafiltration
6th European Downstream Technology Forum September 7, 2010, Sartorius College, Goettingen

Agenda

I. II.

Introduction Overview applications for CFF at RHB

III. Case study I & II IV. Strategies to maintain quality

Richter-Helm offers services for (co-)development and manufacture of biopharmaceuticals
Business Units and Services

In- & Out-Licensing Marketing & Sales

Contract development Contract manufacturing

Business Development Team

GMP-Production Facility, Bovenau
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Richter-Helm was one of the first companies to produce recombinant proteins in accordance to GMP-guidelines
History of Richter-Helm
Timeline 1987 1989 1993 1998 2000 2001 Foundation of Pharma Biotechnologie Hannover and start of GMP production Entering contract GMP manufacturing Broadening service portfolio / establishment of contract development services Building up of development centre in Hamburg Planning and start of construction of the new large scale GMP facility in Bovenau First long-term commercial development and supply agreement for large scale facility signed Initiation of GMP production in Bovenau Acquisition by Gedeon Richter Plc and HELM AG Start of in-house development projects Fully remodelled Hannover facility in operation Capacity enlargement in Bovenau More than 20 years of experience in biopharmaceuticals production 3 development and production locations

2003 2007 2007 2009 2010

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Streamlining their biotechnology activities Gedeon Richter Plc. and HELM AG formed the dynamic joint venture
Owners structure
Gedeon Richter Plc., Budapest, Hungary • Founded 1901, Richter sells APIs and finished form drugs to nearly one hundred countries around the world Largest Hungarian pharmaceutical company, today Turnover in 2008 was ~940 million € generated