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Program July, 10-14 (2006)
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Innovation in Biopharmaceutical Process Development and Manufacturing

Introduction

During the last 10 years more and more biopharmaceuticals have found their way into clinical trials and commercial production. In addition, due to the completion of the sequencing of the human genome, more targets for disease treatment will be found. This will enhance the search for new second-generation biopharmaceuticals and placing them into the pipeline of new potential medicines. So far about 60 million patients worldwide have benefited from these new drugs and the present market for biopharmaceuticals is approximately $ 40 billion. During the period 2000-2004, regulators in Europe and the U.S. approved a total of approximately 75 biopharmaceuticals for human use, including hormones, therapeutic enzymes, vaccines, antibodies, thrombolytics, blood factors and cytokines. An additional 500 biopharmaceuticals are currently evaluated in clinical trials. Among these recombinant proteins, monoclonal antibodies and vaccines constitute by far the largest product categories. The quality of biopharmaceutical products needs to meet the health aim of people treated by these next generation medicines for the many critical diseases. This includes the availability of safe, effective and affordable medicines. However, since a few years the number of new biopharmaceutical medicines coming to the market has reached a plateau. This is caused by the long development times and the high failure rate of new medicines, which in turn is caused by insufficient understanding of the product and the manufacturing process (1).

Alleviation of these bottlenecks means that development and manufacturing of biopharmaceutical products needs innovation, which has to combine science and engineering, and the newest principles of quality management systems. This is also necessary to respond optimal to the latest developments towards personalized medicines used for individualized targeted treatments of human diseases in the near future (2).

Aim and headlines of the Course

The program of the summer Course will be directed at the latest innovations in process development, including principles of quality systems. It will focus on the most critical unit operation in biopharmaceutical development and manufacture, namely the upstream part of the production process. During this stage of the process, the product is actually made. At this stage of the process the product is most prone to changes due to cell culture conditions and physio-chemical stress conditions. It is therefore of the utmost importance not only to control the product formation but also to predict product quality at all stages during the cell culture process. This can only be performed by understanding all the fundamental aspects of the upstream process related with cell culture and product formation.

A manufacturing process is considered as well understood when:

all critical sources of variability are identified and explained,
variability is managed by the process
product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, environmental and other conditions.

The head lines of the course, are based upon these considerations, and concern:

Introduction to Manufacturing Processes for Biopharmaceuticals
Expression systems
Biology in the Bioreactor and inside and outside the Cells
Control strategies, Bioreactor design and In homogeneities
Sensors and data management
Models for Process Understanding

Approach and program of the Course

The 'Pharmaceutical cGMPs for the 21st Century' initiative, which was initiated in 2002 by the American FDA and was intended to enhance and modernize the regulation of pharmaceutical manufacturing and product quality. The major product of this initiative is the PAT guidance document offering a framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (QA). The content of this document (3) and the Q-guidelines (Q8 up to Q10; 4, 5), issued by ICH, are reflected in the course. In addition, the consequences of the coming personalized medicines for development and manufacture will be incorporated in the course. This means that topics as system biology and high throughput technologies for the 'intercellular process understanding' will be presented.

The program is challenging, stimulating and inter-disciplinary combining state of art knowledge and the application in 'real live' manufacturing processes. The presentation of state of the art science and process understanding for the upstream part of the biopharmaceutical manufacturing process is the major aim of the course.

It will also include industrial case studies which will be worked out by the course delegates in small project groups. The case studies will address the manufacturing issues and strategies from all different angles, including large biotech companies, contract manufacturing, start-up companies and small product companies. Topics which will be addressed are e.g type of products, cost of goods, intellectual property, licensing, safety, regulatory and marketing issues. The Course will significantly contribute to your knowledge of these topics.

Who should attend?

Co-workers from companies active in biopharmaceutical manufacturing and process development and PhD-students from academia
Location and period: Wageningen, The Netherlands; July, 10-14 (2006)

Fees: 1,500€ for co-workers from companies and 750€ for PhD students from academia. The fees are without lodging, but lunches are included.

Please inform us know about your interest in the Course and your eventual comment on the program. Your interests and comments can be send to: info@bionovations.org

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