Day 2 :
G-CON Manufacturing Inc., USA
Time : 09:00-09:40
Maik W Jornitz, President of G-CON Manufacturing Inc., is a distinguished industry leader with close to 30 years of experience in bioprocesses, especially sterilizing gradernfiltration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. He has published multiple books, book chaptersrnand over 100 scientific papers. He is a member of the PDA Science Advisory Board, Marketing Advisory Board and Audit Committee, as well as an advisory board memberrnof Artemes Technologies, Biotechnology Industry Council and multiple science trade journals. He received his MEng in Bioengineering at the University of Applied Sciencesrnin Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.
Over the last few years, biopharmaceutical-processing platforms moved from rigid traditional stainless steel to flexible singleuserntechnology. The platforms created the ability to run the process more efficient and with higher agility. The need to evolvernfrom fixed and rigid to flexible and agile systems did not stop with processes, but now shifted focus to facility designs. Traditionally,rnthe facilities built were product dedicated, large if not convoluted and involved lengthy time-to-run periods. To build such facilitiesrnthorough planning is required, especially capacity planning since the inflexibility of the structure does not allow easy scalingrnof the cleanroom space required. Overall, these types of manufacturing systems do no accommodate the need for flexibility ofrnscale, multi-product purposes, neither the benefits of single-use technology processes. Therefore, new facility systems are beingrnintroduced into the industry, ones that can be scaled, easily deployed and moved, if necessary. Prefabricated clean-room unitsrnnow replace so-called flexible modular structures, which did not show the necessary flexibility. These units are built off-site in arnfew weeks and moved into the shell building erected parallel to the manufacture of the clean-room units. Such structures creaternflexibility, scalability, and moreover, re-purposability. However, the cost comparison of these units versus traditional panel builtrnrepresents the same comparison as apples and oranges. The total cost ownership requires to be applied to determine, which facilityrndesign tool in the tool box is best for the specific project.
- Track 7: Apploications of Bioprocess in pharma and QC testing
Track 9: Bioprocess controll and safety
Jeffrey A Lavarias
Central Luzon State University, Philippines
President G-CON Manufacturing, USA
Time : 10:10-10:40
Maik W Jornitz, President of G-CON Manufacturing Inc., is a distinguished industry leader with close to 30 years of experience in bioprocesses, especially sterilizing grade fi ltration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. He has published multiple books, book chapters and over 100 scientifi c papers. He is a member of the PDA Science Advisory Board, Marketing Advisory Board and Audit Committee, as well as an advisory board member of Artemes Technologies, Biotechnology Industry Council and multiple science trade journals. He received his MEng in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.
Over the last few years, biopharmaceutical-processing platforms moved from rigid traditional stainless steel to fl exible single-use technology. Th e platforms created the ability to run the process more effi cient and with higher agility. Th e need to evolve from fi xed and rigid to fl exible and agile systems did not stop with processes, but now shift ed focus to facility designs. Traditionally, the facilities built were product dedicated, large if not convoluted and involved lengthy time-to-run periods. To build such facilities thorough planning is required, especially capacity planning since the infl exibility of the structure does not allow easy scaling of the cleanroom space required. Overall, these types of manufacturing systems do no accommodate the need for fl exibility of scale, multi-product purposes, neither the benefi ts of single-use technology processes. Th erefore, new facility systems are being introduced into the industry, ones that can be scaled, easily deployed and moved, if necessary. Prefabricated clean-room units now replace so-called fl exible modular structures, which did not show the necessary fl exibility. Th ese units are built off -site in a few weeks and moved into the shell building erected parallel to the manufacture of the cleanroom units. Such structures create fl exibility, scalability, and moreover, re-purposability. However, the cost comparison of these units versus traditional panel built represents the same comparison as apples and oranges. Th e total cost ownership requires to be applied to determine, which facility design tool in the tool box is best for the specifi c project.
Virginia State University, United States
Time : 09:40-10:10
Louis Landesman has 34 years of experience in aquaculture including raising aquarium fi sh and penaeid shrimp in SE Asia, sturgeon in California, redfi sh in Mississippi, Chinese carp and tilapia in Israel, aquarium fi sh in Florida and catfi sh in Virginia. Also experience in project planning and implementation. International consultant, researcher, and lecturer specializing in aquaculture and fi sheries. Successfully carried out aquaculture programs in Asia, Africa, Central America and the United States. Experienced in planning and implementing projects, keeping within tight budgets; research and data collection in many scenarios; cross-cultural communication and complexities. Conducted site surveys, planning, evaluation, research and development in fi sh, shrimp and aquatic plant production that contributed to expanding seafood and energy production both in the US and in Asia, Europe, Africa, Central America and the Caribbean.
Duckweeds, small fl oating aquatic plants of the family Lemnaceae, are widely distributed and grow rapidly in freshwater. Duckweeds can be grown in axenic culture on artifi cial media and under artifi cial as well as natural light. Th eir rapid growth, high protein and starch contents and lack of woody tissue make them ideal candidates for biotechnology applications. Agrobacterium-based genetic alteration and transient gene expression have been demonstrated in duckweed species, and bioengineered duckweed plants have been made to manufacture high-value recombinant biopharmaceutical compounds like interferon and monoclonal antibodies. One example was the technology developed at Biolex, a spinoff of research at NC State University. Biolex successfully developed a complete suite of technologies necessary to genetically engineer and manufacture a range of biopharmaceuticals in duckweeds for clinical use. Published information on the history of this company is used as a case study, and lessons from the Biolex failure are discussed.
Title: Downstream process development for purification of a novel anti-MRSA antibody: A case study for antibody aggregation removal
Time : 10:40-11:10
Yanfeng Zhang completed his PhD from Michigan State University and Post-doctoral studies from Pacifi c Northwest National Laboratory and University of Texas Health Science Center at San Antonio. He is Senior Scientist of Process Development of XBiotech, USA, the world’s leading developer of next-generation True Human therapeutic antibodies. He has published more than 20 papers in reputed journals and has been serving as an editorial board member of international journals.
Staphylococcus aureus is gram-positive bacteria that commonly causes human health problem such as skin and respiratory infections, and food poisoning. S. aureus has multiple virulence factors including henolysins, toxins and superantigens, and the strains have high genetic variability. Some strains of S. aureus are also resistant to antibiotics (MRSA and VRSA), resulting in an infection that is diffi cult to control. XBiotech has screened the blood of hundreds of human individuals to fi nd antibodies that directly and specifi cally target S. aureus. One of these true-human antibodies, 514G3, has shown positive results in preclinical studies against S. aureus and is currently being evaluated in a Phase I/II study. During the purifi cation of 514G3 antibody, an unusually high level of protein aggregation (up to 20%) was observed. Th erefore, the protein aggregation problem was fi rst analyzed by a series of analytical methods. Th en, downstream processes were developed to remove the aggregated antibodies. Th is presentation will describe our strategies of resin screen and optimization for the removal of antibody aggregates.
Aligarh Muslim University, India
Title: A new bioprocess to produce low cost powder formulations of biocontrol agents to manage soil borne pathogens of pulses
Time : 11:25-11:55
F. A. Mohiddin working as a faculty at Division of Plant Pathology, SKUAST-K, Srinagar, Kashmir.
A novel process to produce biopesticides based on Trichoderma harzianum, Pochonia chlamydosporia, Bacillus subtilis and Pseudomonas fluorescens have been invented. The biopesticides were developed by taking 1 part of stock culture (sawdust:soil:5% molasses, 15:5:1) of the biocontrol agents and 20 parts carrier (flyash:soil:5% molasses mixture, 5:3:1) (w/w). Greatest CFU counts of the microorganisms were recorded at 25◦C or room temperature during 2–12 weeks of 32 weeks long shelf life test. Seed treatment with the biopesticides @ 5 g/kg seeds carried 103-6 CFU/g seed of chickpea and pigeonpea. The treatments with T. harzianum and P. chlamydosporia effectively controlled the wilt (Fusarium oxysporum f. sp. ciceri, Fusarium udum) and root knot (Meloidogyne incognita) on chickpea (Cicer arietinum L.) and pigeonpea (Cajanus cajan L.) and greatly reduced the soil population of the pathogens. The biocontrol agents established in the soil and their CFU increased significantly (P < 0.05), being greater in pathogen infested soils (P < 0.05) than non infested soil during 4 months period.
Central Luzon State University, Philippines
Time : 11:55-12:25
Jeffrey A. Lavarias working at Central Luzon State University Philippines
Shelling process is one of the primary processes and critical steps in the processing of chocolate or any product that is derived from cocoa beans. It affects the quality of the cocoa nibs in terms of flavor and purity. In the Philippines, small-scale food processor cannot really compete with large scale confectionery manufacturers because of lack of available postharvest facilities that are appropriate to their level of operation. The impact of this study is to provide the needed intervention that will pave the way for cacao farmers of engaging on the advantage of value-adding as way to maximize the economic potential of cacao. Thus, provision and availability of needed postharvest machines like mechanical cacao sheller will revolutionize the current state of cacao industry in the Philippines. A mechanical cacao sheller was developed, fabricated, and evaluated to establish optimum shelling conditions such as moisture content of cocoa beans, clearance where of cocoa beans passes through the breaker section and speed of the breaking mechanism on shelling recovery, shelling efficiency, shelling rate, energy utilization and large nib recovery; To establish the optimum level of shelling parameters of the mechanical sheller. These factors were statistically analyzed using design of experiment by Box and Behnken and Response Surface Methodology (RSM). By maximizing shelling recovery, shelling efficiency, shelling rate, large nib recovery and minimizing energy utilization, the optimum shelling conditions were established at moisture content, clearance and breaker speed of 6.5%, 3 millimeters and 1300 rpm, respectively. The optimum values for shelling recovery, shelling efficiency, shelling rate, large nib recovery and minimizing energy utilization were recorded at 86.51%, 99.19%, 21.85kg/hr, 89.75%, and 542.84W, respectively. Experimental values obtained using the optimum conditions were compared with predicted values using predictive models and were found in good agreement.
- Track 4: Bioprocess Filtration
Track 6: Development to Bioprocess
Track 8: Food and Beverage Testing
Wroclaw University of Technology, Poland
Wroclaw University of Technology, Poland
Time : 12:25-12:55
Prof. Anna Trusek-Holownia, Ph.D., D.Sc., born in Wroclaw, Poland, in 1972. Since 1995 she has carried out scientific work, receiving an M.A. degree in biotechnology, Ph.D. and D.Sc. in chemical engineering. She is a Professor at the Department of Chemistry, Wroclaw University of Technology. She is the chief of Division of Bioprocess and Biomedical Enginering at Wroclaw University of Technology. She is a member of the Federation of Biotechnology, the European Desalination Society and the Polish Membrane Society. She has published more than 150 papers (more than 30 in reputed journals on Web of Science). She is also the author of book titled “ Membrane Bioreactors- models to process design”, Balaban Publication, USA 2011.
Whey is a valuable source of biological active proteins, which contain in their structure immunomodulatory peptides. These peptides might be obtained from enzymatic hydrolysis process connected with membrane separation, mainly nanofiltration. In first step we separated whey proteins. We tested a wide range of micro- and ultrafiltration membranes. The obtained retentate/permeate streams were additionally purified by chromatography methods. After laboratory scale testing, we present a concept for an industrial scale process for the fractionation of the whey proteins with purities of nearly 100%. In the second step using selected whey protein (serum albumin) we obtained peptides by enzymatic hydrolysis with thermolysin. The hydrolysis associated with membrane separation could be integrated in the one unit running in a continuous manner called membrane bioreactor. It provides enzyme immobilization in reaction area. Almost full retention of enzyme decreases of cost. Whereas, product is pure and is not contaminated by unreacted substrate. In order to carry out the mentioned process in membrane bioreactor it was necessary to select an adequate membrane. The most important parameter is cut-off coefficient. The research sets out experiments aimed at membrane selection to separation of peptides obtained after proteolysis. We tested both ceramic and polymeric membranes. In literature there is emphasized that addition of salt results an extra layer – ionic cloud around proteins. Changing of pH causes modification of protein’ load and it affects positive or negative interaction with membrane. Experiments described in this research had attempted to explore the influence of salt addition and pH changing on peptides separation on the nanofiltration membranes. The selected membrane was applied to short peptides isolation during the albumin hydrolysis.
Drexel University, USA
Title: Immobilization of enzymes in mesoporous sol-gel silica, enzymatic digestion of biomass, and selectivity for molecular recognition
Time : 14:20-14:50
Hai-Feng Frank Ji is a Professor in the Department of Chemistry in the College of Arts and Sciences at Drexel University. His current research interests include micro-mechanical sensors for biological and environmental applications, nano-pillars for energy applications, cancer detection and treatment, etc. He has published in more than 130 peer-reviewed journal publications.
Cellobiase enzyme was immobilized in sol-gel solid silica support with D-fructose as a pore-forming agent to make the silica support mesoporous in nature. Th e activity of the immobilized enzyme was studied. We found that the activities of the immobilized samples depended on the porosity and the pore size of the silica host material. With high fructose content, enzymatic activities up to ~80% (with respect to free cellobiase enzyme) were obtained. Th e reusability of our immobilized cellobiase off ers great potential in its application in the enzymatic hydrolysis of biomass. Th e molecular recognition behavior of the fabrication method will also be reported.
Coffee Break 15:50-16:10 @ Foyer
- Track 10: Fuel development technology
Track 11: Analytical and cellline development
Osama O Ibrahim
Consultant Biotechnology, USA
Osmania University, India
Title: Lignocellulose saccharification and direct fermentatation to ethanol: an engineered Saccharomyces cerevisiae codisplaying active cellulases / domains
Time : 16:10-16:40
Mr. B. Chandrasekhar has completed graduation (2006) and post graduation (2008) from Osmania University. Registered for Ph. D (2011) on sustainable bioethanol production using lignocellulosic substates under the guidance of Dr. B. Bhima, Head, Dept of Microbiology, Osmania University, Hyderabad. He attended 3 National and 2 international conferences and 1 workshop within India. He has 2 publications in his area of work and two publications with his colleagues in the laboratory. He has 2 years experience in Vimta Labs Pvt ltd and 2 years of Teaching Experience.
One of the greatest challenges in the 21st centuary is to meet the growing energy demand world over. The future risks of global warming and shortage of petroleum as well as superior environmental characteristics of ethanol as oxygenate for fuels promote the production and usage of bioethanol. This necessitates for the exploitation of lignocellulosic feed stocks such as agricultural and forest residues for the production of ethanol. Fermentation using temperature tolerant yeasts result in faster fermentation rates, reduce contamination, feasible for simultaneous sacarification and fermentation of cellulosic material. Cellulase surface expressing recombinant Saccharomyces cerevisiae are more advantageous over conventional cellulase and ethanol production systems. These yeasts will be doing both efficient cellulase expression and easy conversion of cellulose to ethanol. However, to economize the process it is very necessary to make the yeast to hydrolyze the cellulose and simultaneously ferment to ethanol. In the present study protein engineering was carried out for cellulases (Exo ,Endoglucanases and ß-glucosidases) and their surface display in thermotolerant yeast. For EndoglucanaseN321H mutated enzyme was active over a broader pH range compared to the wild type. Replacement of four aspartates within the active site centre of endoglucanase with alanine and Glutamine results increase in the substrate binding. CBH was designed with and without CBD. Replacement of Alanine of 224 with Histidine and Glutamic acid of 217 with Aspartic acid was found to give more thermostable enzyme. In engineering studies 294 of G replaced with different amino acids for checking the higher activities for substrate recognition. Finally G replaced with aromatic amino acids like F, W, and Y which showed higher activities for substrate recognition than the parent strain. The hydrolytic activities are increased. Enzyme engineering was performed to link the CBD of CBHII to BGL. CBHCBD-BGL exhibited the highest rate of hydrolysis, approximately four fold higher than native enzyme. CBD-CBD-BGL exhibited two fold higher than native enzyme.
Dr.Osama Ibrahim is a highly-experienced Principal Research Scientist with particular expertise in the field of microbiology, molecular biology, food safety, and bioprocessing for both pharmaceutical and food ingredients. He is knowledgeable in microbial screening /culture improvement; molecular biology and fermentation research for antibiotics, enzymes, therapeutic proteins, organic acids and food flavors; Biochemistry for metabolic pathways and enzymes kinetics, enzymes immobilization, bioconversion, and Analytical Biochemistry. Dr. Ibrahim was external research liaison for Kraft Foods with Universities for research projects related to molecular biology and microbial screening and holds three bioprocessing patents. In January 2005, he accepted an early retirement offer from Kraft Foods and in the same year he formed his own biotechnology company providing technical and marketing consultation for new startup biotechnology and food companies. Dr. Ibrahim received his B.S. in Biochemistry with honor and two M.S. degrees in Microbial physiology/ Fermentation and in Applied Microbiology. He received his Ph.D in Basic Medical Science (Microbiology, Immunology and Molecular biology) from New York Medical College. His research dissertation was on the construction of plasmid for the expression of a fusion protein of VEGF121/ Shiga-like toxin as a therapeutic protein for targeting angiogenesis (cancer treatment). Since 1979 he is a member of American Chemical Society, American Society of Microbiology, and Society of Industrial Microbiology.
Diesel fuel is a mixture of hydrocarbons obtained by the distillation of crude oil (petroleum). It plays a vital role in strengthening the global economy and the standard of living. Most of the diesel fuel is refined in the United States and its major uses are for Air, Road, Rail transportations, marine shipping and farming equipments. Biodiesel is a renewable, clean-burning diesel replacement that is reducing United Statesg dependence on foreign crude oil (petroleum), creating jobs and improving the environment. The term biodiesel covers a variety of materials made from vegetable oils, recycled cooking greases or oils, and animal fats. The main reason for the interest in biodiesel project because it is a renewable source of clean energy not derived from crude oil (petroleum). In the United States, biodiesel fuel production has grown from about one-half million gallons in 1999 to an estimated production capacity of over 75 million gallons. This production capacity is about 0.2 percent of the total diesel fuel production in United States. . .This presentation will address biodiesel production methods and yield from different feedstock sources, methods of crude biodiesel refining, the refined biodiesel properties, applications and it future economic and development.