Presentations and Reports

Selected presentations by Fred S. Larimore:

Presentations:

Larimore, F. S., Keynote Address “Upstream and Downstream Processing, A Question of Balance,” Millipore BioForum 2008, Tokyo, Japan, 9/08.

Larimore, F. S., “Development, Scale-up, and Technical Transfer of Purification Processes,” Wyeth Internal Vaccine Development Technical Forum, Durham, NC, 5/08.

Larimore, F. S., “Utilizing Quality by Design and Design Space for Continuous Improvement.” Interphex, Philadelphia, PA, 3/08.

Larimore, F. S., IBC Panel Discussion on the Future of Chromatography, IBC, BioPharm Conference, Boston, MA, 11/07.

Larimore, F. S., “The Future of Process Development,” Interphex, New York, NY, 3/07.

Larimore, F. S., “The Future of Process Development,” ISPE Midwest Chapter Meeting, Indianapolis, IN, 9/06.

Larimore, F. S., “BioProcess Development Issues” and “BioProcess Development Case Study,” ISPE ‘Closing the Knowledge Gaps:  Process Development Symposium,’ Arlington, VA, 6/06.

Larimore, F. S., “BioProcess Development Issues” and “BioProcess Development Case Study,” ISPE ‘Closing the Knowledge Gaps:  Process Development Symposium,’ Arlington, VA, 6/05.

Larimore, F. S., Weisman, D., Siwak, M., Brunkow, R., “BioProcess Development and Scale-up of Downstream Puritifcation,” SBP Institute, San Francisco, CA, 5/05.

Larimore, F. S., Weisman, D., Siwak, M., Brunkow, R., “BioProcess Development and Scale-up of Downstream Puritifcation,” SBP Institute, Cambridge, MA, 9/04.

Larimore, F. S., “Basics of Biotechnology,” FDA Investigator Training, Invited Speaker, Rockville, MD, 2/04.

Larimore, F. S., “Validation Expectations for Chromatography Resins and Columns,” IBC "Validation for the Production of Biologicals" Conference, Munich, Germany, 12/03.

Larimore, F. S., “Chromatography Media and Process Control,” Society of Bioprocessing Professionals (SBP) In-house Chromatography Training Program, Amgen, Inc., Providence, RI, 11/03.

Larimore, F. S., “Enhancing Manufacturing Capacity and Productivity,” IBC's International Antibody Production & Downstream Processing and Multisource Biologics, Invited Speaker, Basel, Switzerland, 10/03.

Larimore, F. S., Brunkow, R., Hilgert, M., Kahn, D., Raghunath, B., “Purification Scale-up for Bioprocessing Systems,” SBP Institute, Washington, D.C., 8/03.

Larimore, F. S., “Insulin Comparability,” PDA Comparability Conference, Invited Speaker, 2/03.

Hilgert, M. D., Larimore, F. S., Xie, Y., Mun, S., Wang, N.-H. L., “Continuous Size Exclusion Chromatography for Separation of Insulin from a Multicomponent Mixture,” AIChE Meeting, 11/02.

Larimore, F. S., “FDA Expectations about Column Lifetimes and Resin Reuse,” IBC’s Well Characterized Biologics Conference, Invited Speaker, 10/02.

Larimore, F. S., “Insulin Comparability,” ICH Q5E: Establishing the Comparability of Biotechnology/Biologic Products, Invited Speaker, 9/02.

Larimore, F. S., Brunkow, R., Hilgert, M., Siwak, M., "BioProcess Scale-up,” ASME BioProcess Technology Seminars, Instructor/Lecturer, 10/02.

Larimore, F. S., Brunkow, R., Hilgert, M., Siwak, M., "BioProcess Scale-up,” ASME BioProcess Technology Seminars, Instructor/Lecturer, 10/01.

Larimore, F. S., Brunkow, R., Hilgert, M., Siwak, M., "BioProcess Scale-up,” ASME BioProcess Technology Seminars, Instructor/Lecturer, 11/00.

Larimore, F. S., Brunkow, R., Hilgert, M., Siwak, M., "BioProcess Scale-up,” ASME BioProcess Technology Seminars, Instructor/Lecturer, 10/99.

Larimore, F. S., Miner, D., Bird, T., “Comparability Protocols Applied to Insulin Changes,” IBC “Strategic Use of Comparability Studies and Assays for Well-Characterized Biologicals” Conference, Invited Speaker, 6/99.

Larimore, F. S., Miner, D., Bird, T., “Comparability Protocols Applied to Insulin Changes,” PhRMA Regulatory SubCommittee Meeting, Invited Speaker, 4/99.

Larimore, F. S., Maloney, A., Busse, S., McDonough, J., Rajagopalan, N., “PreNDA Review of rhPTH(1-34) CMC section of NDA,” Presentation to FDA, 12/98.

Larimore, F. S., “Comparability Protocols Applied to Insulin Changes,” PhRMA Regulatory SubCommittee Meeting, Invited Speaker, 11/98.

Larimore, F. S., Brunkow, R., Hilgert, M., Siwak, M., "BioProcess Scale-up,” ASME BioProcess Technology Seminars, Instructor/Lecturer, 10/98.

Larimore, F. S., Bird, T., Miner, D., Frank, B., "Comparability Protocol for BHI Manufacturing,” Presentation to FDA, 6/98.

Larimore, F. S., “Process Monitoring,” California Separation Science Society, Invited Speaker and Session Leader, 1/98.

Larimore, F. S., Brunkow, R. “Adopting Strategies for Efficiently maximizing Commercial Production of a Bulk BioProduct,” IIR Conference “Developing Strategies for Fast and Efficient Technology Transfer in the Pharmaceutical and Biotech Industry”, Invited Speaker, 1/98.

Larimore, F. S., Brunkow, R., Hilgert, M., Siwak, M., "BioProcess Scale-up,” ASME BioProcess Technology Seminars, Instructor/Lecturer, 9/97.

Larimore, F. S., Brunkow, R., Hilgert, M., Siwak, M., "BioProcess Scale-up,” ASME BioProcess Technology Seminars, Instructor/Lecturer, 10/96.

Larimore, F. S., “BHI Production”, Biosynthetic R&D Seminar Series, Invited Speaker, 1996.

Larimore, F. S., Lloyd, Y., Maloney, A., Davis, G., Frank, B., "Recycles and Reworks in BHI Manufacturing Process,” Presentation to FDA, 12/94.

 

Regulatory Reports and Technical Reports:

Larimore, F. S., “Manufacturing History Report:  Human Insulin,” 2006.

Larimore, F. S., “Biosynthetic Human Insulin; Proinsulin Derived CMC API Process Description,” 2005. (Updated the CMC API Manufacturing Section of the NDA.)

Larimore, F. S., “Discussion of Critical Process Parameters,” 2004.

Larimore, F. S., “Membrane and Filter Lifetime Strategy,” 2004.

Larimore, F. S., “Chromatography Resin and Column Lifetime Strategy,” 2003.

Larimore, F. S., Response to CPMP Questions, United States Questions, European Union Questions, Australian Questions, Swiss Questions, Canadian Questions for Forteo Submission, 2001-2002.

Larimore, F. S., “rhPTH(1-34) Active Pharmaceutical Ingredient Process Validation Summary Report,” 2001.

Larimore, F. S., “rhPTH(1-34) Active Pharmaceutical Ingredient Development History Report Summary,” 2001.

Larimore, F. S., “rhPTH(1-34) Active Pharmaceutical Ingredient Process Development History Report,” 2001.

Larimore, F. S., “Active Pharmaceutical Ingredient Manufacturing CMC section for rhPTH(1-34) NDA,” 2000.

Larimore, F. S., Miner, D., Bird, G., Frank, B., “Draft Comparability Protocol for BHI,” submitted to the FDA, 6/98.

Larimore, F. S., ”Blend 10- Pre-Approval Supplement to BHI NDA”, submitted to FDA, 1996.

Larimore, F. S., White, R., Kaiser, R., “NorValine Report,” prepared for the BHI Annual Report, 1995.

Larimore, F. S., “Forward Processing Criteria and Recycles- Changes Being Effected Supplement to BHI NDA,” submitted to FDA, 1995.

Kelly, G., Larimore, F. S., “Converting Beef Iletin DMF to NDA- Pre-Approval Supplement for Beef Iletin,” submitted to FDA, 1995.


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