Abstracts ESACT 2011 Workshop: From Molecule to Market-PD Solutions

Freedom(TM) CHO-S(TM) Platform: Go from gene to clone in less than 4 months, achieving MAb titers of 1-3 g/L without milestone or royalty payments / Peggy Lio, Life Technologies; and Volker Sandig, ProBioGen AG

Berlin, (PresseBox) - ProBioGen is proud to pronounce the launch of Life Technologies' innovative Freedom(TM) CHO-S(TM) Kit at the ESACT 2011 in Vienna. The kit was developed in cooperation of ProBioGen AG and Life Technologies Corporation. At the ESACT 2011 Workshop "From Molecule to Market-PD Solutions" our CSO, Dr. Volker Sandig, is going to talk in a joint presentation with Dr. Peggy Lio (Life Technologies) about the history of the development process of the Freedom(TM) CHO-S(TM) Kit. Dr. Steve Gorfien (Life Technologies) and Mr. Christian Ryan (Life Technologies) will talk about Media and Feed Platforms and PCR-based assays for in process testing. The workshop will take place on May 15, 2011 (12:00-14:00, Vienna) in the Imperial Rooms at the Vienna Hofburg Congress Center.

In this workshop you will learn how you can:

- Go from gene to clone in less than 4 months
- Control of cell function by nutrient and process integration
- Use Real time PCR assays for in-process testing to detect cell culture contaminations We are looking forward to meeting you in Vienna at the ESACT.

Abstracts ESACTStable cell line development is a critical phase of biotherapeutic development. While several CHO based platforms are widely marketed, they are costly to access-even for research use only evaluation. To enable everyone to perform stable cell line development, we have developed a CHO-S(TM) based kit platform that allows end users to go from transfection to stable clone in under 4 months. Only one scientist is needed to perform the optimized workflows and all critical components are included. Key to the overall process is how transfection, selection and cloning have been co-optimized. MAb titers achieved with these platforms are ~1 g/L for an un-optimized simple glucose fed batch process and up to 3 g/L when more complex nutrient feeds are employed. Research use rights are granted upon kit purchase. Commercial licensing is unprecedented and requires only a one-time fee.

Media and Feed Platforms: Control of cell function by nutrient and process integration - Steve Gorfien, Life Technologies

Sustained growth of the biopharmaceutical market has created a need for high-titer processes to meet increasing demand and to reduce manufacturing costs. Advances in recombinant cell line engineering have resulted in high producing clones with high nutritional demands. Depletion of critical nutrients in a production process can limit the potential of these clones, causing reduced titers and resulting in inefficient, costly processes to compensate for media or feed deficiencies. Through the integration of base and feed cell culture media development, we have addressed nutrient limitation issues in rCHO cultures and obtained substantial improvements in titer by sustaining specific productivity for extended periods of time. Such approaches are clearly effective, but are time consuming and limited by the large number of possible component combinations and the need to integrate process parameters like pH, temperature, dissolved oxygen, agitation rate and time of feed addition with a balanced nutrient composition. We have applied high throughput (HT) tools that enable simultaneous evaluation of multiple nutrient and process variables in up to 420 simultaneous conditions. Case studies will be presented demonstrating the power of HT tools to evaluate broad design spaces, making possible rapid creation of chemically defined processes with multi-fold increases in titers while maintaining final product quality.

Highly sensitive PCR-based assays for in-process testing: Rapid detection of cell culture contamination - Christian Ryan, Life Technologies

The possibility of viral or mycoplasma contamination of mammalian cell culture during large scale manufacturing of biological therapeutics has always been a concern in the industry. Because the traditional adventitious agent or mycoplasma tests take considerable time, contaminant testing is generally only conducted during cell banking and following final harvest. We have recently developed real-time PCR based assays that allow for rapid, highly sensitive detection of mycoplasma, mouse minute virus (MMV) and vesivirus 2117. These rapid assays allow for testing for the presence of these agents at multiple points during the cell culture manufacturing process, permitting the earliest possible detection of a contamination event. The importance of rapid detection using molecular based testing has been further highlighted recently in public reports of viral contamination events that affected both product supply and product quality. We will review the assay designs, sensitivity, sample preparation and proprietary discriminatory positive/extraction controls developed for these assays during our presentation.

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