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Pre-Conference Short Course 1 Detailed Agenda


Monday, August 22 • 8:30 to 11:30am


 

Workshop Chair:  Scott D. Storms, Ph.D., Consultant, Cell Culture Consulting

 

8:30 Media Optimization to Increase Productivity in Bioreactors

Martin Jordan, Ph.D., Associate Manager, Biotech Process Sciences - Medium Development, Merck Serono
 

9:15  Rational Design of Culture Media: Integration of Multiple Approaches

Scott StormsScott D. Storms, Ph.D., Consultant, Cell Culture Consulting

Current design of cell culture media for bioproduction of recombinant therapeutics requires effective use of a diverse set of scientific and management disciplines. Cell line, culture media, and process all have a large impact on product yield and quality. They can also have strong interactions requiring good understanding of the each area and pragmatic development strategies integrating them for best results. Done correctly, this can lead to short development timelines while maximizing success. To achieve high culture performance in the limited timelines given for process development, different phases can performed concurrently and modern methods of optimization such as Design of Experiment can be effectively used. To further complicate matters, quality and regulatory issues must be considered throughout all development projects. When conducted in a rational and integrated way, culture media and process development can improve yields while meeting project deadlines.

10:00 Break

10:30 Case Study:  Use of Design of Experiments to Develop a Highly Productive Process for Manufacture of a Humanized Mab in GS-CHO Cells

Steven ChamowSteven Chamow, Ph.D., Head, Technical Services, Avid Bioservices, Inc.

We were asked to optimize an initial process for production of a humanized IgG1 mAb to significantly increase titer.  Our goals were (1) to convert the upstreamprocess to a chemically defined medium formulation, and (2) to shorten time in the production bioreactor from 17 to 14 days, while (3) increasing titer to >1.5 g/L and (4) maintaining a similar biochemical profile ofthe glycoprotein product.  The basal medium was not changed.  A basic design of experiments (DOE) approach was taken, testing several factors, including medium concentrates, supplements and a chemically defined hydrolysate substitute.  After major factors were identified, composition and timing of feed mixtures were optimized.  Moreover, we explored galactose supplementation to influence glycan distribution in the product.  Details of this process optimization program will be presented as an example of the value DOE approaches can bring to optimization of upstream processes.

11:00 Application of Innovative NMR-based Methods for Bioprocess Optimization and Monitoring of Biological Production

Frederic GirardFrederic Girard, Ph.D., Managing Director, Spinnovation Analytical BV

Cell culture process development and optimization is critical for the commercially viable production of recombinant protein products and virus. It will impact the downstream production and manufacturing processes including scalability and costs. It is thus a pre-requisite to fully understand and control the cell growth conditions as early as possible, i.e. during the phase of cell-line development. Ideally, one wants to rapidly understand and monitor the factors that are most influential to cell-growth and production of a recombinant drug candidate. Among these factors, the feeding strategy plays a central role, as well as for e.g. the accumulation of potentially toxic metabolites.

To address these issues, we propose to apply an innovative NMR-based approach which provides rapid and reliable profiling of culture media to support the cell culture development and upstream processing. Indeed, this multiplex approach enables the access to the concentration of large number of analytes present in culture media, such as feed components, contaminants and metabolites. This method particularly well suited to the analysis of mammalian cell culture has been also successfully applied to other cellular systems. During this short course, we will first introduce the basics of NMR technology and methods, present how it could be applied to culture media to help to monitor cell cultures and what it delivers. After detailing the performance of this analytical technology and comparing to other existing methods, we will further develop on its application to support the development of feed strategy and its use for cell media validation.

11:30 End of “Optimizing Media” Short Course


Speaker Bio’s: 

 

Martin Jordan, Ph.D., Associate Manager, Biotech Process Sciences - Medium Development, Merck Serono

Martin Jordan has over 20 years of experience in cellular biotechnology. For his PhD thesis at the ETH in Zürich he studied the shear stress sensitivity of mammalian cells in serum free media. Then he participated on a pioneer project setting the basis for large-scale transient expression during his Post-Doc project at Genentech before joining the laboratory of cellular biotechnology (LBTC) of professor Florian Wurm at the EPFL in 1995. During the following 9 years Martin was involved in transient expression, the use of green fluorescent proteins, pH control in shaken systems etc. and he co-developed with external industrial partners new disposable products that successfully entered the market as “tubespin”, “Mini PCV” or Volupac™.
In 2005 Martin Jordan joined the Merck Serono manufacturing site in Vevey (Switzerland) to develop a proprietary medium for CHO cells. In his current position he established a state of the art high throughput platform for media optimization that delivers to Merck Serono fed-batch processes for the production of recombinant proteins.

Scott D. Storms, Ph.D., Consultant, Cell Culture Consulting

Scott D Storms, Ph.D., has over twenty years experience in scientific management and has led culture media and strategy optimization projects for over 20 recombinant CHO cell lines. He currently is running a scientific consultancy practice where he advises and provides services to his clients for upstream process development for manufacture of biologics. Prior to this Scott was Director of Research and Development at Irvine Scientific for 8 years where he gained broad experience in the culture media business as the Design Control team leader for many custom and catalog products. He received his PhD in Biological Sciences from the University of California at Irvine where he currently sits on the Dean’s Leadership Council and received postdoctoral training at Case Western Reserve University in the Dept of Neurosciences.

Steven Chamow, Ph.D., Head, Technical Services, Avid Bioservices, Inc.

Steven Chamow, Ph.D., currently serves as Head of Technical Services for Peregrine Pharmaceuticals/Avid Bioservices in Tustin, CA.  In this role, Dr. Chamow leads a group responsible for the development, optimization,  validation and transfer of manufacturing processes from clients of Avid.  During his 24-year career in biotechnology, he has contributed to the development of three marketed products (Avastin®, Natrecor®, Vectibix®).  Previously, he served as Senior Vice President, CMC, at Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics).  Prior to Intradigm, Dr. Chamow was Vice President, Process Sciences, at Genitope Corporation and at Abgenix, Inc., (acquired by Amgen) where he built the company’s process sciences department and helped to lead the design and construction of Abgenix’ award-winning production facility in Fremont, CA (recently sold by Amgen to Boehringer-Ingelheim to become its first North American production facility).  Before Abgenix, he served as Director of Biopharmaceutical Development at Scios, Inc. (acquired by J&J), and as a scientist and senior scientist in process development at Genentech, Inc. (acquired by Roche).  Dr. Chamow was educated at the University of California (UC Santa Cruz, B.A. in biology; UC Davis, Ph.D. in biochemistry), and completed postdoctoral training at the National Institutes of Health.  He is author or co-author of more than 45 scientific publications and patents, co-editor of a 1999 book entitled Antibody Fusion Proteins, and a keynote speaker on several occasions at biopharmaceutical industry conferences.

Frederic Girard, Ph.D., Managing Director, Spinnovation Analytical BV

Frederic Girard is co-founder of Spinnovation Analytical BV where he spends his time between some management activities and contributions to industrial analytical research and development projects. The company is a private Contract Research Organization specialized in delivering analytical services and Contract Research to Industry: Pharmaceuticals, Chemicals & Polymers, and Food & Fragrances.

Over the past 5 years, Spinnovation has developed specific know-how and workflows focusing on activities such as Impurity Profiling and Metabolite Identification.

Frederic obtained a PhD in Biophysical Chemistry at the CNRS in 2000 (Orleans, France). After 3 years post-doc (Umea, Sweden and Nijmegen, the Netherlands), he established the company Spinnovation Analytical in 2004 with 4 other partners. From the combined academic and industrial experiences, he has developed strong expertise in the application of NMR spectroscopy to address issues both in the area of Material - and Life Science (solution/solid-state NMR, hyphenated-NMR).

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