Biochemical Technology (BIOT) Division 225th ACS National Meeting, New Orleans  March 23-27, 2003

BIOT Sessions in New Orleans (ACS 2003)

1. Advances in Biocatalysts
2. Advances in Bioseparations
3. Advances in Cell Culture Process Development 
4. Advances in Chromatography
5. Advances in Expression Systems 
6. Advances in Fermentation Process Development 
7. Advances in Formulation 
8. Advances in Metabolic Engineering
9. Advances in Plant Biotechnology 

10. Advances in Polypeptide Production Technology: Accelerating Product and Process Development

11. Advances in Protein Folding, Aggregation, and Modification
12. Advances in Tissue Engineering and Cell Therapy 
13. Advances in Vaccine Development, Gene Delivery and Gene Therapy
14. Therapeutic Antibody Issues: Fundamentals and Production Processes
15. Bioinformatics, Genomics, and Proteomics 
16. Bioprocess Monitoring and Control
17. Collection, Analysis and Use of Process Data
18. Continuous Bioprocessing 
19. Environmental Biotechnology 
20. Evaluation of Column Performance in Preparative Chromatography
21. Mechanistic Aspects of Virus Cell Interactions
22. Novel Bioanalyses using Lab on a Chip Technology
23. Poster Session BIOT 
24. The Process of Process Development 
25. Separations and Process Technology for Genetic Therapy and Diagnosis
26. Validation of Biopharmaceuticals Processes

Advances in Biocatalysis [Sessions] [Submit Abstract]

The symposium focuses on recent progress in the general field of Biocatalysis involving applications of isolated enzymes and whole cells.  Of particular interest are methods for improvement of biocatalysts through directed evolution and other techniques, and strategies for cofactor regeneration and for overcoming product inhibition.  Novel approaches for enzyme discovery and for accelerating biocatalytic process research & development through bioinformatics, high-throughput screening technology and other tools are being sought. This session welcomes contributions from industry on large-scale applications of biocatalysis.

Co-Chairs:  Dr. Rachel Chen, Chemical Engineering, Virginia Commonwealth University, 804-827-7038, rchen@vcu.edu; Dave Pollard, Merck & Co. Inc, PO Box 2000, Rahway NJ 07065, 732-594-2680, david_pollard@merck.com  

Advances in Bioseparations [Sessions] [Submit Abstract]

This session will concentrate on theoretical principles and practical considerations that underlie the use of separation techniques for the isolation and purification of therapeutic biomolecules. Approaches that lead to a better theoretical understanding of real mixture separations in both chromatographic and membrane systems are welcome. Novel separations or novel modes of carrying out existing separations, the development of new tools and strategies for downstream process development and quantitative tools for process optimization will be accepted. Submissions that combine theory and practice, or relate one to the other, are particularly sought. 

Co-chairs: Mark R. Etzel, University of Wisconsin, 1415 Engineering Drive, Madison, WI  53706, 608-263-2083, etzel@engr.wisc.edu. Abhinav A. Shukla, Amgen Inc., 51 University Street, Seattle, WA 98101, 206-587-0430 x54257, shuklaa@amgen.com.

Advances in Cell Culture Process Development  [Sessions] [Submit Abstract]

In recent years, numerous innovative advances within the field of cell culture process development have led to the development of highly productive, efficient biopharmaceutical manufacturing processes.  This session is intended as a forum for the discussion of issues surrounding the development and scale-up of such processes.  More specifically, topics for discussion include optimization of product expression (both product quality and quantity), scale-up and scale-down efforts to further expand the understanding of mixing/mass transfer challenges, as well as advances in process monitoring/control strategies.  Additionally, papers related to the evaluation of novel process technologies/equipment will also sought for inclusion in this session.

Co-Chairs: Colette S. Ranucci, Merck Research Laboratories, P.O. Box 4, West Point, PA 19486-0004, 215-652-6052, colette_ranucci@merck.com Sadettin S. Ozturk, GlaxoSmithKline, 709 Swedeland Road, King of Prussia, PA 19301, (610) 239-3912, s_ozturk@earthlink.net

Advances in Chromatography  [Sessions] [Submit Abstract]

While preparative chromatography continues to be an indispensable technique in the biotechnology and pharmaceutical industries, novel approaches continue to be developed in response to its ever-widening scope of application.  This session seeks to highlight the latest advances in the field.  Topics of interest include, but are not limited to: the chromatography of very large moieties such as virus particles; validation and optimization issues including packing, qualification, and robustness; accounting for interactions among various chromatographic steps, or between a chromatographic step and another unit operation; the use of detectors such as MS and NMR in the development of more efficient preparative separations.

Co-Chairs: Ajoy Velayudhan, Oregon State University, 116 Gilmore Hall, Corvallis, OR 97331-3906, 541-737-6293, velayuaj@engr.orst.edu.  Anurag Rathore, Pharmacia Corporation, 700 Chesterfield Parkway North, Chesterfield, MO 63198, 636-737-6790, anurag.s.rathore@pharmacia.com

Advances in expression systems  [Sessions] [Submit Abstract]

Due to an increasing demand for expression of complex proteins and macromolecules and the need for large-scale expression or moderate to high-throughput expression, improved approaches to expression are needed. This session will focus on new approaches to expression of proteins or macromolecules in bacterial, yeast, insect, or mammalian system. These approaches may include cloning strategies, expression strategies, clonal selection.

Chair: Anne Skaja Robinson, Department of Chemical Engineering, University of Delaware, 259 Colburn Laboratory, Newark, DE  19716, robinson@che.udel.edu, (302) 831-0557 Noel Fong,Zymogenetics, Inc., 1201 Eastlake Ave. East, Seattle, WA 98102-3702, Tel: 206.442.6530 FAX: 206.442.6608, fongn@zgi.com 

Advances in Fermentation Process Development  [Sessions] [Submit Abstract]

The session will focus on recent advances and future challenges in microbial fermentation technology including bacterial, fungal and yeast systems for the production of native and recombinant proteins, nucleic acids, oligosaccharides and metabolic products. Papers are solicited in all aspects of fermentation process development including physiology, metabolic pathway analysis, bioreactor design and scale-up, bioprocess optimization, development of new analytical tools and application of novel approaches for troubleshooting and productivity improvements. Case studies from industrial contributors are strongly encouraged. 

Chairs: Zheng Jian Li, EntreMed Inc, 9640 Medical Center Drive, Rockville, MD 20850, zhengl@entremed.com, 240-864-2779.   Ilse I. Blumentals, Merck & Co., Inc. WP17-201, West Point, PA 19486, ilse_blumentals@merck.com 215-652-8618.

Advances in Formulation [Sessions] [Submit Abstract]

This session will address the unique challenges encountered during the development of novel formulations and formulation delivery systems for biologics. Aspects of formulation related to biologics stability, degradation mechanisms, impacts of upstream processing on final product stability, excipient effects, and novel formulation and delivery strategies will be covered. Specific topics will include: physical/chemical degradation pathways, solubility issues, multidose formulations, lyophilization, spray-dried formulations, interfacial phenomena, delivery issues, biologics/excipient and/or adjuvant interactions. Biologics of interest include: live/attenuated viral vaccines, virus-like particles, therapeutic proteins, polysaccharides, conjugates, and nucleic acids. Speakers from industry are strongly encouraged.

Co-Chairs: Sangeetha L. Sagar, Merck Research Laboratories, P.O. Box 4, West Point, PA 19486-0004, 215-652-2311, sagar@merck.com . Erik J. Fernandez, Department of Chemical Engineering, University of Virginia, 102 Engineers' Way, Charlottesville, VA  22904-4741, 434-924-1351, erik@virginia.edu.

Advances in Metabolic Engineering [Sessions] [Submit Abstract]

Metabolic engineering is concerned with modification at the genetic level followed by a thorough evaluation of the effect on cell physiology that guides the next round of manipulations to achieve a desired phenotype.  Advances in abilities to modify cells, perform high-throughput screening and selection, and characterize cell physiology are dramatically impacting the strategies and methods of metabolic engineering. This session will feature research that describes such advances as well as new applications of metabolic engineering principles.  Papers that describe experimental, computational, or integrated approaches are welcome.   

Co-Chairs: Ryan T. Gill, Department of Chemical Engineering, UCB424/ECCH111, University of Colorado, Boulder, CO 80309, 303-492-2627, rtg@colorado.edu.; Tim Dodge, Fermentation Development, Genencor International, 925 Page Mill Road, Palo Alto, CA 94304-1013, tdodge@genencor.com, Phone: 650-846-7644 (Fax 650-845-6525)

Advances in Plant Biotechnology [Sessions] [Submit Abstract]

Plants potentially offer a cost-efficient and readily scalable platform for the production of a wide array of biological products. Several important crop plants are available as potential hosts due to the increasing success of transformation with recombinant DNA. This session will encompass technical issues related to the utilization of plants for the production of chemicals, enzymes, therapeutic proteins, vaccines, and novel or improved materials. Specifically, papers dealing with the metabolic engineering of plant pathways, novel constructs for the controlled and stable expression of heterologous genes, and the purification of products from plants are welcome. Both research directed at increasing the manufacture of products with existing markets as well as fundamental research on the development of novel products are of interest.

Chair: John A. Morgan, School of Chemical Engineering, Purdue University, 1283 CHME Bldg., W. Lafayette, IN 47907, (765) 494-4088, jamorgan@purdue.edu. Co-chair: Jacqueline V. Shanks, Department of Chemical Engineering, 3031 Sweeney Hall, Iowa State University, Ames, IA 50011-223I, (515) 294-4828 jshanks@iastate.edu.

Advances in Polypeptide Production Technology: Accelerating Product and Process Development [Sessions] [Submit Abstract]

This session will focus on recent advances and future challenges in microbial production of native and recombinant polypeptides (enzymes, proteins, and peptides). Papers are solicited in all aspects of product and process development. Of particular interest are methods and approaches to accelerate the transfer of polypeptide products from discovery to manufacture. Examples of relevant topics include optimization of product expression, approaches to scale-up and scale-down, strategies for technology transfer, and development and application of tools to better understand physiology and improve product quality and productivity. Both academic contributions and industrial case studies are strongly encouraged.

Co-Chairs: Hendrik J. Meerman, Genencor International, 925 Page Mill Road, Palo Alto, CA 94304, hmeerman@genencor.com , Phone: 650-846-7645 (Fax 650-621-7945) ; JinCai Li,  Diversa, 858-526-5357,  jli@diversa.com.  

Advances in Protein Folding, Aggregation, and Modification [Sessions] [Submit Abstract]

Protein function is intimately tied to appropriate protein folding and post translational modifications, while loss of function and/or disease are related to aggregation.  This session seeks presentations related to both in vivo and in vitro protein folding, aggregation and post translational modifications.  Topics that are of scientific, medical, and industrial significance are sought after.  Possible areas of interest include but not limited to: mutational studies, protein refolding, chaperone effects, solvent effects, computer modeling, protein stability and denaturation, protein expression, protein glycosylation, other protein modifications, protein aggregation in vivo and in vitro, and aggregation prevention/Inhibition. 

Cochairs:  Theresa Good, UMBC, Department of Chemical and Biochemical Engineering, 1000 Hilltop Circle, Baltimore, Maryland 21250 (410) 455-3403, tgood@umbc.edu .  Amos Tsai, Human Genome Sciences, Inc., Protein Development, 9410 Key West Avenue,Rockville, MD 20850 (301) 610-5790 EXT. 3649, amos_tsai@hgsi.com .

Advances in Tissue Engineering and Cell Therapy [Sessions] [Submit Abstract]

While tissue engineering has developed rapidly as an interdisciplinary field of study, many challenges remain in the development of engineered replacement tissues and cellular based therapies.  This session will focus broadly and seeks to include papers that represent the breadth of the field. In particular, papers are welcome which deal with cell-biomaterial interactions, biomaterial development, biomimetics, bioreactor design for engineered constructs, effects of stimuli on tissue development, in vitro neovascularization, and gene/drug delivery in engineered constructs.

Co-Chairs: Julia M. Ross, University of Maryland Baltimore County, 1000 Hilltop Circle, Baltimore, MD 21250, 410-455-3414, jross@umbc.edu. Teng Ma, Department of Chemical Engineering, Florida State University, 2525 Pottsdamer St., Rm 131, Tallahassee, FL 32310, 850-410-6558, Fax: 850-410-6150,  teng@eng.fsu.edu 

Advances in Vaccine Development, Gene Delivery and Gene Therapy [Sessions] [Submit Abstract]

Delivery of antigens and genetic materials into the human body, either in vivo or ex vivo, has been utilized extensively for traditional applications such as vaccination against infections by microbes, and for novel therapeutic applications to treat inherited or acquired genetic diseases. Advances continue to be made in development of such novel vaccines and gene delivery systems with major clinical applications for unmet medical needs. This symposium will highlight particular advancements and address broad development challenges in these areas. Issues related to design of product candidates including, but not limited to conjugate, recombinant, and combination vaccines, as well as DNA plasmids and viral and non-viral vectors. In addition, development of manufacturing processes may be addressed, including those regarding purification, characterization, formulation, and testing. Papers, which deal with specific engineering and biological issues encountered during development of product candidates are particularly welcome.

Co-chairs:  Weichang Zhou, Sr. Director, Process Development, Protein Design Labs, Inc., 34801 Campus Drive, Fremont, CA 94555, Tel: (510)574-1647, Fax: (510) 742-2726, WZHOU@PDL.COM.  Willie Sun, Aventis Pasteur, Discovery Drive, Swiftwater, PA 18370, Tel: (570) 839-5590, Fax: (570) 839-2580, willie.sun@aventis.com; Peter C. Fusco, Baxter BioScience - Vaccines, Baxter Healthcare Corporation, 10150 Old Columbia Road, Columbia, MD 21046, Tel: 410-309-7134, Fax: 410-381-3385, peter_fusco@baxter.com

Theraputic Antibody Issues: Fundamentals and Production Processes [Sessions] [Submit Abstract]

Recently recombinant monoclonal antibody-fused proteins have evolved into a major new class of biotherapeutics, realizing many years of research and development efforts to deliver promising, novel therapies to diseases such as Rheumatoid Arthritis and cancers. Due to the need for high dosage, large scale manufacturing capacity has been recognized as a key bottleneck for commercialization. Consequently, complex issues associated with process development and product manufacturing deserve focused attention. This session will cover all aspects of cell culture/fermentation and purification process development, manufacturing, validation, analytical, regulatory, quality and compliance issues of recombinant monoclonal antibody-fused proteins. In addition, the fundamental understanding of those issues will be discussed.

Topics of interests include:

• Upstream process development - cell line improvement, metabolic analysis and engineering, media optimization, understanding of cellular activities (apoptotic pathways, cell cycle progression, etc.), scale-up of cell culture processes, optimization of product expression (quality and quantity), glycoprotein analysis, glycosylation control, scale-up and scale-down strategies for process validation, process monitoring/control strategies, novel process technologies/equipment, etc.
• Downstream process development - cell removal (membrane and centrifuge steps), preparative chromatography (ion exchange, protein A, HIC, etc.), viral clearance steps, scale-up and scale-down strategies for process validation, process monitoring/control strategies, novel process technologies/equipment and analytical methodologies, process integration, quality and compliance issues, etc.

Co-Chairs: Steven S. Lee, Bristol-Myers Squibb Company, P.O. Box 4755, Syracuse, NY 13221-4755, Phone: 315-432-9516, FAX: 315-432-2343, e-mail: steven.lee@bms.com. Erik J. Fernandez, University of Virginia, 102 Engineers' Way, Charlottesville, VA 22904-4741, Phone: 434-924-1351, FAX: 434-982-2658, e-mail: erikf@virginia.edu 

Bioinformatics, Genomics, and Proteomics [Sessions] [Submit Abstract]

Developments in genomic and proteomic technologies have allowed quantitative monitoring of the cellular components that determine cellular function in many organisms. The current biotechnological challenge is how this information can be used for enabling discoveries in many areas of biochemical technology (e.g., metabolic engineering, drug discovery, tissue engineering, and bioprocess development). This session will include contributions that describe applications of existing technologies (e.g., use of genomic and proteomic information in cellular and metabolic engineering), improvement and development of new technologies and methodologies (e.g., improvements in proteomic and transcriptomic technologies, new separation strategies), and computational and mathematical frameworks for the quantitative analysis of the available information (e.g., systems engineering application on biological systems, computational methods for prediction of protein structure and function). 

Chairs: Vassily Hatzimanikatis, Department of Chemical Engineering, Northwestern University, Evanston, IL 60208-3120, vassily@northwestern.edu,  847-491-5357. 

Bioprocess Monitoring and Control [Sessions] [Submit Abstract]

The complexity of bioprocessing using biological catalysts, including microbes, animal cells or mixed cultures leads to interesting challenges for the monitoring and control of such processes.  Paper topics for the "Bioprocess Monitoring and Control" Session may include but are not limited to the following:  Applications of on-line estimation for process monitoring and control; the use of new tools for process monitoring, including new methods for the elucidation of physiological information; novel methods of bioreactor control and downstream processing, including the use of non-linear control models; identification and integrated development of bioprocesses; control methods leading to the optimization of bioprocesses.

Co-Chairs: Claire Komives, Department of Chemical and Materials Engineering, One Washington Sq., San Jose, CA  95192-0082, (408)924-4002, Claire.Komives@sjsu.edu,  Harry Lam, Genentech, Inc., 1 DNA Way, South San Francisco, CA  94080-4990, (650)225-4586, lam.harry@gene.com

Collection, Analysis and Use of Process Data [Sessions] [Submit Abstract]

As development and technology transfer timelines for new biological products become increasingly aggressive, biotechnology and pharmaceutical companies need to manage and interpret ever larger quantities of information.  This session will present the state of art in efficient data collection, statistical and computational tools for data analysis, and novel applications to bioprocess design, monitoring, control, and optimization. Papers are invited which deal with novel aspects of:

• bioprocess data acquisition methods;
• process development and/or manufacturing database applications;
• statistical and other computational tools for critical parameter identification, trend analysis, quality control and allowable operating range identification, or process optimization
• use of development or historical manufacturing databases for technology transfer and process troubleshooting.

Contributions are encouraged that address issues concerning fermentation/cell culture and downstream processing, as are papers from academic and industrial laboratories.

Co-Chairs: David E. Block, Department of Viticulture and Enology and Department of Chemical Engineering and Materials Science, University of California, One Shields Avenue, Davis, CA 95616, 530-754 6046, deblock@ucdavis.edu .  Victor Goetz, ImClone Systems, Inc., 22 Chubb Way, Somerville, NJ 08876, 908-541-2375, goetzv@imclone.com .

Continuous Bioprocessing [Sessions] [Submit Abstract]

Although continuous processing is a well established, cost-effective and often superior manufacturing option in the chemical industry, the majority of today's biotech processes remains batch oriented. Nevertheless, as the biotechnology industry matures and becomes more competitive, continuous bioprocessing emerges as an attractive alternative for a variety of applications. For complex and inherently unstable biopharmaceuticals, continuous processes allow minimization of the products residence time in non-ideal milieu, as well as, the adjustment of constant conditions for assurance of optimal product quality. Other examples include continuous fermentation for highly efficient and cost effective beer production in the food industry. In general, continuous bioprocessing technologies offer advantages like smaller equipment sizes and high volumetric productivity, as well as, a high degree of automation.

Papers are invited on all aspects of continuous bioprocessing, from continuous fermentation and cell culture to continuous separation technologies like simulated moving bed (SMB) and true moving bed (TMB) chromatography, continuous extraction and electrophoresis. This includes, but is not limited to, research papers on development of continuous cell-lines, novel equipment design, process automation and scale-up, modeling and optimization, as well as, discussions of practical and regulatory aspects of the implementation of continuous bioprocesses into large scale manufacturing.

Chairs: Jens H. Vogel, Cell Culture and Bioprocess Engineering, Bayer Corporation, 800 Dwight Way, P.O. Box 1986, Berkeley, CA 94701. Phone (+)510-705-4751. Fax (+)510-705-7368. e-mail: jens.vogel.b@bayer.com. Alois Jungbauer, Institute of Applied Microbiology; University of Agricultural Sciences, Vienna, Austria; Tel: +43 1 36006 6226, Fax: +43 1 36 97 615; email: jungbaue@hp01.boku.ac.at 

Environmental Biotechnology [Sessions] [Submit Abstract]

This session will include all aspects of environmental biotechnology, with particular emphasis on fundamental approaches, the use of molecular tools, and novel applications.  Relevant topics include, but are not limited to: molecular analysis of microbial communities in treatment systems, pollutant fate in phytoremediation, design of new microbial strains for biodegradation (including metabolically-engineered strains), bacterial transport and survival, modeling of horizontal gene transfer, and novel bioreactors for treatment of contaminated air, water, or soil.  Appropriate application areas may range from bioremediation to waste treatment to the release of genetically enhanced microbes (GEMs). 

Chairs: Kenneth F. Reardon, Department of Chemical Engineering, Colorado State University, Fort Collins, CO  80523-1370, 970-491-6505, reardon@engr.colostate.edu; Thomas K. Wood, Department of Chemical Engineering, 191 Auditorium Road, U-3222, Storrs, CT 06269-3222, 860-486-2483, twood@engr.uconn.edu 

Evaluation of Column Performance in Preparative Chromatography [Sessions] [Submit Abstract]

Due to the increasing number of production scale chromatography columns being implemented in the biotechnology industry, there exists an increasing demand for techniques that can accurately evaluate chromatographic performance.  This session will give an overview of technologies that are used to evaluate the performance of preparative chromatography columns.  Specifically, papers are welcome which deal with packed bed integrity analysis, chromatographic performance over resin lifetime, assessing variability in packed beds, quality assurance review of chromatographic data, automated analysis of chromatographic data, and other technologies related to measuring chromatographic performance. 

Co-Chairs: Jörg Thömmes, IDEC Pharmaceuticals Corp., 3010 Science Park Road, San Diego, CA 92191, 858-431-8308, jthommes@idecpharm.com.  Tina M. Larson, Genentech, Inc., 1 DNA Way, South San Francisco, CA  94080, 650-225-4783, tinam@gene.com.

Novel Bioanalyses using Lab on a Chip Technology [Sessions] [Submit Abstract]

In the past decade, numerous advances have been made concerning lab on a chip technology with regards to controlling and monitoring flow, mixing of reagents, detection, sample introduction, and of course, the design and fabrication of the chips.  Most of these advances have been made in order to optimize electrophoretic separations.  Importantly, chip based technology is now being employed for other types of analyses that do not solely focus on electrophoresis.  This session will showcase some of the recent advances in applying chip based techniques to bioanalytical and biomedical research. 

Chairs: Dana Spence, Department of Chemistry, Saint Louis University, 3501 Laclede, St. Louis, MO  63103 spenced@slu.edu (314) 977-2836. R. Scott Martin, Department of Chemistry, University of Iowa, 305 Chemistry Building, Iowa City, IA 52242-1294, scott-martin@uiowa.edu, (319) 353-0379.

Mechanistic Aspects of Virus Cell Interactions [Sessions] [Submit Abstract]

This session focuses on advances made towards understanding molecular and mechanistic aspects of cell-virus interactions in the context of viral vaccine development and gene therapy.  Relevant topics include: virus binding and internalization, viral receptor trafficking, viral packaging and secretion, studies involving cell cycle dependence of viral infection, viral productivity and gene expression as functions of cell characteristics, viral delivery optimization, novel techniques to follow viral infection and gene expression.  Papers closely related to other aspects of virus-cell interactions, both delivery and production, will also be considered.

Chairs: Gargi Maheshwari, Ph. D Merck & Company, gargi_maheshwari@merck.com Fermentation and Cell Culture WP17-201 P. O. Box 4 West Point, PA 19486 Tele: 215-652-6756 Fax: 215-993-4884 gargi_maheshwari@merck.com ; David Schaffer, Ph.D., Department of Chemical Engineering, University of California at Berkeley, 201 Gilman Hall, Berkeley, CA 94720-1462, Tel: (510) 643-5963, Fax: (510) 642-4778, schaffer@cchem.berkeley.edu.

Poster Session [Sessions] [Submit Abstract]

The BIOT poster session will cover all aspects of biochemical technology. In addition to areas covered by other sessions, such as fermentation/cell culture, bioseparation, biosensor etc., abstracts in areas not explicitly covered by other sessions such as biodegradation etc. are also welcomed in this session. Participation from industry is highly encouraged.

Co-Chairs: Zheng Jian Li, EntreMed Inc, 9640 Medical Center Drive, Rockville, MD 20850, zhengl@entremed.com, 240-864-2779. Foster Agblevor, virginia Polytechnic Institute & State University, 212 Seitz Hall, Biological Systems Engineering Department, Blacksburg, VA 24061, fagblevo@vt.edu, 540-231-2578; Gan Wei, CuraGen Inc. 16 Commercial Street, Branford, CT 06405, GWei@CuraGen.com, (203) 871-4445

The Process of Process Development [Sessions] [Submit Abstract]

This session will address the process by which biopharmaceuticals are brought from an idea in the labs of basic research to a licensed manufacturing process.  We will accept both specific case studies and philosophical papers on process development.  Some examples of relevant topics would be: development of “systems” to facilitate rapid process development, introduction of new technologies to speed process development, scale-up and scale-down approaches, development of new analytical approaches to speed process development and the efficient conduct of technology transfer into pilot scale and final manufacturing facilities.

Chairs:  Hari Pujar, Bioprocess R & D, Merck & Co. Inc, P. O. Box 4, Mailstop: WP17-301, West Point, PA 19486, hari_pujar@merck.com , 215-652-8177. Joanne Beck, Process Development and Manufacturing, Altus Biologics Inc, 625 Putnam Avenue, Cambridge, MA 02139, jbeck@altus.com, Phone: (617) 299 - 2967 (Fax (617) 299 - 2950)

Separations and Process Technology for Genetic Therapy and Diagnosis  [Sessions] [Submit Abstract]

Due to the increasing number of therapeutic approaches involving gene therapy, improved separation technologies are needed not only to facilitate large-scale therapeutic manufacture but also for use in small-scale diagnostic applications. This session will give an overview of novel separation technologies used in all aspects of gene therapy and genetic diagnostics. Notably, papers are welcome which deal with DNA purification, viral construct separation, diagnostic separations, and other separation and process technologies for gene therapy related products. 

Chairs: Jason C. Murphy, Merck Research Laboratories, P.O. Box 4, West Point, PA 19486-0004, jason_murphy@merck.com, (215) 652-4704. Richard C. Willson, Department of Chemical Engineering, University of Houston, 4800 Calhoun Ave., Houston, TX 77204-4004, willson@uh.edu, (713) 743 4308.

Validation of Biopharmaceuticals Processes  [Sessions] [Submit Abstract]

This session will address various aspects of process validation involved in the licensure of recombinant biologics, for both protein and non-protein products. All aspects of process development including product synthesis (fermentation and cell culture), purification, and fill/finish will be discussed. Validations which are prospective, concurrent, or retrospective to licensure will be described. Paper topics may include the design of efficient validation strategies, the validation of novel unit operations, new validations developed for novel therapeutics, and case studies of entire validation packages. Technical problems addressing the translation of scale between laboratory or pilot studies and full-scale manufacturing will be considered. Activities required for licensing and support for multiproduct facility validation will be presented. Special considerations for revalidation of approved manufacturing processes and validation of Contract Manufacturing Operations will also be discussed.

Co-Chairs: Brian D. Kelley, Wyeth BioPharma, 1 Burtt Road, Andover, MA 01810, Phone: 978-247-2098, Fax: 978-247-2604, Email: bkelley@wyeth.com. Chris Z. Chen, Biologics Process Technology, Merck and Co., Inc. P.O. Box 4, West Point, PA 19486-0004, Phone: 215-652-0220, Fax: 215-652-7822, Email: chris_chen@merck.com .

Page Last Modified: Thursday, April 10, 2003 08:55 PM
by: marten@umbc.edu