Process Development Manufacturing Management
Process Validation Process Equipment Design
Peter Levy founded PL Consulting in 2007 after spending over 30 years working in the biopharmaceutical industry. Mr. Levy's industry experience includes employment with large and small biopharmaceutical companies, a pharmaceutical equipment supplier, and a contract R&D company. PL Consulting offers services in the areas where Mr. Levy has direct industry experience as an employee of an independent biopharmaceutical company. His broad background enables him to appreciate the view points of the various players involved in pharmaceutical process development and manufacturing.
Mr. Levy is trained as a Chemical Engineer (MS degree from MIT) and Chemist (BS degree from Tufts University). His previous employers include Biogen, Inc (major biopharmaceutical company); Millennium Pharmaceuticals (mid-sized biopharmaceutical company); Altus, Inc (small biotechnology company); Dynatech R&D Company (contract research and development company); and Amicon, Inc (pharmaceutical equipment supplier, subsequently purchased by Millipore Corporation).
Mr. Levy's most significant employment in the Biopharmaceutical industry was at Biogen, Inc. His 13-year tenure at Biogen began as a Senior Development Engineer when the company had a workforce of less than 300 employees. Mr. Levy left Biogen as Director of Development Engineering and Validation after the company had successfully registered three commercial products and grown to over 2000 employees. While at Biogen, Mr. Levy played a key role in developing clinical and commercial Drug Substance and Drug Product processes, designing and procuring Custom Process Equipment, establishing the company's Equipment Validation Program, establishing and managing the company's Process Validation Program, establishing the systems for Technology Transfer for internal and external manufacturing, and building Biogen's state-of-the-art Biologics Manufacturing facilities.
Mr. Levy continued his work in the areas of process and equipment development, technology transfer, and process validation after leaving Biogen and joining Millennium and Altus. Presently he is providing those services to clients through PL Consulting, LLC. Mr. Levy has also actively participated in many industry forums that offer opportunities to present and exchange ideas and experiences. He is currently an active member of PDA where he serves on the Biotechnology Advisory Board and participates on a variety of Task Forces. He chaired the Task Force that published the Technical Report on "Validation of TFF Systems" in 2009 and actively participated on Tasks Forces on Process Validation (publication in 2005) and Biotechnology Cleaning Validation. In addition, Mr. Levy has accumulated an impressive list of publications and presentations (provided below).
Selected Publications and Presentations:
Levy, PF (chairperson) with PDA Task Force. 2009. “Validation of Tangential Flow Filtration in Biopharmaceutical Applications; PDA Technical Report 15 (Revised)," Parenteral Drug Association, Inc.
Levy, PF and Yoshida, A. 2006. “Crystallization as a Unit Operation for Downstream Processing of Therapeutic Proteins,” presented at American Association of Pharmaceutical Scientists Annual Meeting (Boston, June)
PDA Task Force. 2005. “Process Validation of Protein Manufacturing,” Parenteral Drug Association (PDA) Technical Report #42, member of Task Force and contributing author
Levy, PF. 2003. “The Cost Contribution of Downstream Processing in Recombinant Protein Manufacturing Processes – Optimization Strategies,” presented at 7th International IBC Conference on Production and Economics of Biopharmaceuticals, San Diego, CA (October 2003)
Levy, PF. 2001. “Linking Development & Manufacturing Through Validation: What Do Demonstration Lots Demonstrate?” presented at 6th Annual GMPs by the Sea Conference, Hilton Head, SC (August 2001)
Levy, PF and Fotopoulos, A. 1998. “Freezing Purified Bulk Proteins: Modeling the Process at Bench Scale,” presented at 1998 Colorado Protein Stability Conference, Breckenridge, CO (July 1998)
Levy, PF. 1997. “Practical Considerations in the Design and Implementation of a Crossflow Microfiltration System for Use in GMP Manufacturing,” presented at American Institute of Chemical Engineers Annual Meeting, Los Angeles, CA (November)
Levy, PF. 1997. “Use of Cationic Flocculants for Clarification of Cell Culture Broths,” presented at BioPharm Conference, San Francisco, CA (May)
Levy, PF and Fotopoulos, A. 1996. “Temperature, pH, and Concentration Profiles During Freezing of a Protein Solution - An Engineering Investigation into the Freezing Process,” presented at PDA Annual Meeting, Philadelphia, PA (November)
Levy, PF, Myers, JA, and Gallo, C. 1996. “ Removal of Mammalian Cells and Cell Debris with the Aid of Flocculants,” presented at Recovery of Biological Products VIII Conference, Tucson, AZ (October)
Levy, PF and Earle, RS. 1994. “The Effect of Channel Height and Channel Spacers on Flux and Energy Requirements in Crossflow Filtration,” Journal of Membrane Science, Vol 91
Levy, PF and Meissner, D. 1993. “The Development and Scale-Up of a Crossflow Microfiltration Process for Clarification of Mammalian Cell Conditioned Media,” presented at the Summer Bioengineering Conference, Breckenridge, CO (June)
Levy, PF and Yundt, B. 1991. “Comparison Between Taylor Vortex and Cross-flow Filtration of Proteins and Mammalian Cell Broths,” Fluid/Particle Separation Journal, Vol 4(3) (September)
Levy, PF and Sheehan, JJ. 1991. “Performance Characteristics of Polysulfone and Cellulose Membranes for the Ultrafiltration of Biological Process Streams,” BioPharm (April)
Levy, PF and Earle, RS. 1990. “The Effect of Channel Spacers and Channel Height on Flux, Energy Requirements, and Process Economics in Crossflow Ultrafiltration,” presented at ICOM ‘90, Chicago, IL (May)
Levy, PF. 1990. “Issues in the Optimization and Scale-Up of Crossflow Filtration Processes,” presented at The New England Regional Biotechnology Conference, Gallilee, RI
Sheehan, JJ, Hamilton, BK, and Levy, PF. 1990. “Pilot Scale Membrane Filtration Process for the Recovery of an Extracellular Bacterial Protease,” in Downstream Processing and Bioseparation, J-FP Hamel, JB Hunter, and SK Sikdar, eds. ACS Symposium Series
Levy, PF, Pinto, S, and Sheehan, JJ. 1989. “A Comparison of Hydrophobic and Hydrophilic Membranes for the Ultrafiltration of Proteins: Flux and Cleaning Characteristics,” presented at 46th Annual Meeting of the Society of Industrial Microbiology, Seattle
Levy, PF, Sanderson, JE, and Cheng, LK. 1984. “Kolbe Electrolysis of Mixtures of Aliphatic Organic Acids,” Journal of the Electrochemical Society, Vol 131: 773-777
Sanderson JE, Levy, PF, Cheng, LK, and Barnard, GW. 1983. “The Effect of Pressure on the Product Distribution in Kolbe Electrolysis,” Journal of the Electrochemical Society, Vol 130: 1844-1848
Levy, PF, deRiel, SR, and Sanderson, JE. 1983. “Development of a Biochemical Process for Production of Olefins from Peat,” in Organic Chemicals from Biomass, DL Wise, ed. Addison-Wesley
Levy, PF, Sanderson, JE, Ashare, E, and deRiel, SR. 1983. “Alkane Liquid Fuel Production from Biomass,” in Liquid Fuel Developments, DL Wise, ed. CRC Press
Deen, W, Levy, PF, Partridge, R. and Wei, J. 1981. “Assay for Methotrexate in Nanomolar Concentrations with Simultaneous Detection of Citrovorum Factor and Vincristine,” Analytical Biochemistry, Vol 114: 355-361.
Levy, PF, Barnard, GW, Garcia-Martinez, DV, Sanderson, JE, and Wise, DL. 1981. “Organic Acid Production from CO2/H2 and CO/H2 by Mixed Culture Anaerobes,” Biotechnology and Bioengineering, Vol 23: 2293-2306.
Levy, PF, Sanderson, JE, and Wise, DL. 1981. “Development of a Process for Production of Liquid Fuels from Biomass”, in the Third Symposium on Biotechnology in Energy Production and Conservation, CD Scott, ed. Series No. 11: 239-248
Levy, PF, Sanderson, JE, Kispert, RG, and Wise, DL. 1981. “ Biorefining of Biomass to Liquid Fuels and Organic Chemicals,” Enzyme and Microbial Technology, Vol 3: 207 - 215