Biochemical Engineer: Bioprocessing, Bioreactions, Fermentation and Related Engineering and Biochemical Processes (1182)
Expertise
Bioprocess engineering, equipment and construction
Process development and design
Equipment design for fermenter, bioreactor systems, separation systems and related processes
Pilot plant and manufacturing facility process integration
Scale-up; troubleshooting; and start-up
Experience
Consultant 2001 – Present
Since retiring from Fluor Daniel, consulting for engineering and manufacturing companies in the field of Bioprocessing. Example of consulting include:
Paul Muller: Proposals, conceptual and detail designs for the production of fermenter and bioreactor systems ranging in size from 20 to 20,000 liters.
Fluor Daniel, Phoenix Imperative and Process Facilities, Inc.: General process biotechnology consulting.
Genentech Inc: Prepared specifications for automation systems.
FLUOR DANIEL (1988 – 2001)
Representative projects at Flour Daniel are:
IDEC Nimo 1 Facility, Oceanside, CA. Lead Process Engineer for the schematic design of a grass-roots, large-scale, multi-product mammalian cell culture plant. Included Media & Buffer Prep, Cell Culture & Recovery, Purification, Clean Utilities.
Eli Lilly, B130 Renovation, Indianapolis, Indiana. This project included upgrading of current production facility for increased production and addition of a new multiproduct processing area. Responsible for conceptual, preliminary, and detail design including isolation, LP and HPLC, and membrane systems.
Rhone-Poulenc, Luling , LA. Upgrade of water system to meet cGMP standards.
Amgen AMPM Project, Longmont, CO. Design of a new multi-product facility for biotherapeutic proteins based on bacterial fermentations. Responsible for conceptual and preliminary process engineering.
BASF Bioresearch Corporation, Worcester, Massachusetts. Expansion of an existing facility to produce clinical trial material by mammalian cell culture. Responsible for conceptual, preliminary and detail design.
Roche Citric Acid Facility, Wuxi, China. Updating and expansion of an existing large scale fermentation and recovery plant. Contributed towards new material handling, fermentation, mycelial separation and ion exchange areas during conceptual and preliminary design.
Cargill, PGLA Facility, Lactic Acid Plant, Blair, Nebraska. Responsible for media prep, fermentation, and biomass separation for a lactic acid production train during preliminary engineering.
MedImmune, Biotech Manufacturing Facility - Cell Culture Module, Frederick, Maryland. Responsible for preliminary and detailed design for a mammalian cell culture facility producing biotherapeutic proteins. Design included scale-up of bioreactors/fermenters and purification systems.
Wyeth-Lederle, Pneumo Expansion Biologics Project, Sanford, North Carolina. Responsible for conceptual study, preliminary design, and detailed engineering phases for a pneumonia vaccine facility. Key issues included BL2-LS fermentation and recovery areas.
Amgen Suite III, Amgen, Thousand Oaks, California. Study for the expansion of an existing plant. The facility was to accommodate the purification of two new drug products and decompress the original microbial plant. Major emphasis is on process scheduling to minimize the impact on clean utilities.
Amgen, MPF Biologics Project, Juncos Puerto Rico. Responsible for the conceptual process design of a new multiproduct plant producing human therapeutic proteins. This plant included both bacterial and mammalian cell culture facilities along with integrated purification suites.
Erythritol Plant Conceptual Design, Midwest, USA. Managed the process design of the conceptual study for the production of erythritol through fermentation. The scope included large-scale fermentation, broth filtration, product separation, evaporation, crystallization, centrifugation, drying, and packaging.
Synergen, Lake Centre Biologics Facility, Boulder, Colorado. Responsible for the design of a production facility for therapeutic proteins. Design scope included scale-up of fermentation, recovery, and purification processes from pilot plant data. Unit operations included bacterial fermentation, cell separation and disruption, large-scale chromatography systems and clean utilities. Design criteria incorporated validation and CGMP compliance and NIH regulations for large-scale recombinant BL1-LS manufacturing.
Biochemie, IL-6 Facility, Kundl, Austria. Directed the conceptual design of a facility to produce therapeutic proteins. The process included fermentation, inclusion body recovery, and multistage chromatographic purification.
Immunex, Seattle, Washington. Responsible for the preliminary design for a pharmaceutical protein production facility based on recombinant organisms. This multiproduct plant contained both bacterial and yeast recombinant production systems, intra- and extra-cellular product recovery systems, large-scale HPLC columns, a fill/ finish area.
AECI, Lysine Plant, Umbogintwini, South Africa. Developed feasibility and preliminary design for a feed-grade lysine facility incorporating alternative fermentation substrate strategies. Projected and interpreted laboratory scale data to production scale to aid in process development. Key issues included large-scale fermenter design (aeration/agitation, heat transfer), purification (continuous moving bed chromatography), and waste management.
Ajinomoto, Expansion, Eddyville, Iowa. Responsible for the expansion of a food grade lysine plant. Facility design included large-scale ion exchange separation, multistage continuous evaporation, crystallization, continuous centrifugation and fluid bed drying, bulk storage, and packaging.
Wacker-Chemie, Germany. Supervised a design team for a conceptual design of a multiproduct biotech facility producing specialty enzymes and enzyme-modified products as well as food grade amino acids.
Ajinomoto Expansion, Raleigh, North Carolina. Responsible for the expansion of a multiproduct bulk pharmaceutical grade amino acid facility. Process design aspects included ultrafiltration, evaporation, crystallization, batch centrifugation, and vacuum drying.
Roche RMS, Project Excellence Phase II, Pleasanton, CA. Relocation of Diagnostic Kit manufacturing facilities from New Jersey to California.
MILES LABORATORIES, ELKHART, INDIANA. (1965 – 1988)
Developed and implemented new technologies including new methods of media preparation, continuous sterilization, optimization of fermentation aeration-agitation conditions, solid-liquid separations by advanced filtration and centrifugation techniques, membrane processes for cell separation and product concentration and purification, special drying processes, and parameter optimization for immobilized enzyme processing and operation.
VIRTIS CORP., GARDINER, NY (1963 – 1965)
Responsible for the design of a line of laboratory fermenters.
BIOCHEMICAL PROCESSES INC., NEW YORK, NY. (1961 – 1963)
Managed an equipment manufacturing division supplying the Biotech industry fermenters and ancillary equipment.
Honors & Publications
PROFESSIONAL AFFILIATIONS
American Institute of Chemical Engineers
PUBLICATIONS
"What Chemical Engineers Need to Know about Biotechnology," Chemical Engineering, contributor.
"Enzyme Activity Maintenance in Packed-Bed Reactors via Continuous Enzyme Addition", Biotechnology and Bioengineering, co-author.
"Using Fault Analysis Methods to Improve Bioreactor Safety", Annals of the New York Academy of Science, co-author.
"Glucose Isomerase: in Comprehensive Biotechnology, The Principles of Biotechnology: Engineering Considerations, Pergammon Press, New York, contributor.
"Let an Expert System Troubleshoot", CHEMTECH.
Education
B.S., Chemical Engineering, Lehigh University
Graduate Bioengineering Studies, Columbia University