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2007 Presentations
May 17
Development of a Lyophilized Viral-Vectored Vaccine
Roberto DePaz, Ph.D. senior sevelopment scientist, Alphavax
Lyophilization:
Product-Centered Development and Transfer
Anthony Klos, principal PD Eng., Formulation Development Group
Protein Stability During Processing:
Challenges and Strategies
Mark Cornell Manning, Legacy BioDesign
Novel Approaches to Enhance the Pulmonary Delivery of Biotherapeutics
William Zimlich, Activaero Technologies
2006 Presentations
March 16
- Process Engineering and Design: The Role of Facility Design in The Role of Facility Design in Contamination Control
- Jeffery N. Odum, principal, NCBioSource
- Current USP Perspectives on Microbiological Contamination Control
- Radhakrishna S.Tirumalai, Ph.D, scientific staff liaison, Microbiology and Sterility Assurance Expert Committee
- Process Risk Assessment to Ensure Microbial Contamination Control Process
- Lucia Clontz, Microbiology director, Diosynth Biotechnology
2005 Presentations
April 21
- Confidential Design of Experiments Applications in Process Development
- Upstream Development and Production, Diosynth Biotechnology
March 2
- ISPE-BPD Biogenerics Track
- The Technology Show Presentations focus on:
- Facilities, Engineering, and Validation
- Quality Assurance and Regulatory Affairs
- Clinical Trails Materials
- Biotechnology Process Development
Jan. 20
- A Regulatory Perspective on the Application of and Compliance with GLPs in the Performance of Preclinical and Nonclinical studies for the Development of Biologics Products
- Tanya Scharton-Kersten, regulatory consultant for the North Carolina Office of The Biologis Consulting Group
- Regulatory perspectives on product manufacture and characterization of biologicals during clinical development
- Susan Kirshner, Biologist, Laboratory of Immunology, U.S. Food and Drug Administration
2004 Presentations
Nov. 18
- Validation Considerations for Disposable Components and Systems
- Biogen Idec
- Present Capabilities and Future Disposable Bioreactors
- Wave Biotech LLC, Bridgewater, N.J.
- Wave Mixers for Bioprocessing
- Daniella Kranjac, Wave Biotech LLC
- Disposable Chromatography: Present Capabilities and Future Possibilities
- Tom Ransohoff, BioProcess Technology Consultants
- Disposable Filling: Innovative Enabling Technologies for Disposable Manufacturing
- Millipore
- Lynx Valves and Connectors
- Millipore
- Disposable Bioprocessing: State of the Industry, Economics and a Novel Manufacturing Platform Case Study
- Geoffrey Hodge, Xcellerex vice president of technology
- Kleenpak Connector
- Monica Cardona, Pall Life Sciences
Sept. 16
- Bioanalytical Systems for Process Optimization and Control
- John Costello, Groton Biosystems Acton, Mass.
May 20
- Hot Issues of Process Characterization-Abstracts
- Robert Seely, associate director of corporate validation for Amgen Inc.
- Risk Assessment in Manufacturing Processes; Business and Regulatory Benefits
- Dr. Robert Seely, associate director of corporate validation, Amgen Inc.
- Re-engineering EBA Systems and Media for Reliability and Throughput
- Terry Mayes, process media consultant, GE Health Care
- A Case Study in the Effects of Chromatography Scale-up
- Suzanne Stella, manager of manufacturing technology, Biogen Idec
- Using the Small-Scale Laboratory to Provide Information for Packing and Evaluating Large-Scale Columns
- Dr. Greg Runyon, senior scientist for purification process development, Diosynth Biotechnology
- Column Packing Procedures at Production Scale
- Aaron Allen, senior process engineer for manufacturing sciences, Diosynth Biotechnology
April 22
- Comparability Protocols for Process Change - Abstracts
- Andrew Chang, Ph.D., acting deputy director for the Division of Hematology, OBRR, CBER, FDA
- Comparability Protocols: FDA's Perspective and Experience
- Dr. Andrew Chang, CBER, FDA
- Case Studies in the Use of Comparability Protocols to Support Changes in REMICADE Bulk Manufacturing
- Dr. Michele Myers, assistant director, Department of Process Sciences, Centocor Inc.
- Implementing Process Improvements after IND Submission
- Dr. James Rebbeor Sr., process development scientist I, Bayer Technology Department
Feb. 19
- Analytical and Stability Considerations for Biologic Product Development - Abstracts
- Anthony R. Mire-Sluis, Office of Biotechnology Products, CDER, FDA
- Regulatory Perspectives on Test Method Qualification and Validation for Product Development
- Anthony R. Mire-Sluis, office of biotechnology products with CDER and FDA
- Analytical Role in Support of Process Development, Selected Case Studies
- Amir Malek, Wyeth vaccines research
- Analytical and Stability Considerations to support IND's and BLA's
- Sid Advant, director for technology transfer and clinical operations with Diosynth RTP Inc.
Jan. 22
- Recovery and Separations Technology - Abstracts
- Plate and Frame Filter Presses for the Biopharmaceutical Industry Brian Powers, systems sales manager of Pall Life Sciences
- The Use of Scalable Hollow Fiber Membranes in Cell Processing and Clarification Applications
- Michael Beauchemin, product manager for flat sheet cassette products with Amersham Biosciences
- Retentate Chromatography - Mass Spectrometry (RC-MS) A Novel Technique to Facilitate Rapid Protein Analysis and Purification
- Tom Bronzert, process proteomics sales specialist of Ciphergen Biosystems Inc.
- Centrifugation as a Method of Primary Recovery for Cell Culture Products
- Robert Barloga, product support manager of Alfa Laval Inc.
2003 Presentations
Nov. 20
- Fundamentals of Venture Financing in Biotechnology Industry. Impact of Good Process Development's on Future of Funding
- Clay Thorp, general partner of BioVista Capital
- Key Business Applications - What? And Why?
- Christian Fortunel, president and CEO of Biomango Corp.
- NIH Funding Opportunities for Biotechnology Process Development
- Dr. Jeff Chulay with AlphaVax Inc.
- Process Development and the Business of Biotechnology - Abstracts
- The Role of Integrated Clinical Development in Helping Process Development Attain Its End Goal, i.e., Getting a Drug Approved
- Dr. Nava Rao, associate director of clinical development for Cato Research.
- The Top Ten Tips for Protecting Intellectual Assets
- Caroline Horton Rockafellow, Daniels, Daniels and Verdonik, P.A.
Oct. 23
- Developing Value-Added Products in Transgenic Plants - Abstracts
- Bioprocessing Process Development
- Pilot-scale Production of Recombinant Therapeutic Proteins in Tobacco
- Dr. Sancha Salgueiro of Meristem Therapeutics
- Creating a Consortium on Plant and Fungal Bioengineering
- Dr. Bill Thompson of North Carolina State University
- Transgenic Plants as a BioProduction Platform: Targeting Therapeutics, Vaccines and Adjuvants
- Dr. Carole Cramer of Virginia Polytechnic Institute and State University and co-founder of CropTech Corporation and Biodefense Technologies
Oct. 2
- Bioproduct Development: An Overview of cGMP Considerations for the Qualification/Validation of Processes
- Christina F. Fair of Global Compliance Solutions Inc.
- Formulation Development Process of Multivalent Glycoconjugate Vaccines
- Dr. Robert Seid of Wyeth Vaccines
- Process Development and Characterization: Application to Fermentation Development for Vaccine Manufacture
- Dr. Tsu-shun Lee of Wyeth Vaccines
- Process Validation for Cell Therapy Products
- Scott Burger of Advanced Cell and Gene Therapy LLC