Day 1 :
Keynote: Downstream process development for purification of a novel anti-MRSA antibody: A case study for antibody aggregation removal
Time : 10:35-11:20
Yanfeng Zhang completed his PhD from Michigan State University and Post-doctoral studies from Pacific Northwest National Laboratory and University of Texas HealthrnScience Center at San Antonio. He is Senior Scientist of Process Development of XBiotech, USA, the world’s leading developer of next-generation True Human therapeuticrnantibodies. 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 respiratoryrninfections, and food poisoning. S. aureus has multiple virulence factors including henolysins, toxins and superantigens, andrnthe strains have high genetic variability. Some strains of S. aureus are also resistant to antibiotics (MRSA and VRSA), resultingrnin an infection that is difficult to control. XBiotech has screened the blood of hundreds of human individuals to find antibodiesrnthat directly and specifically target S. aureus. One of these true-human antibodies, 514G3, has shown positive results in preclinicalrnstudies against S. aureus and is currently being evaluated in a Phase I/II study. During the purification of 514G3 antibody,rnan unusually high level of protein aggregation (up to 20%) was observed. Therefore, the protein aggregation problem was firstrnanalyzed by a series of analytical methods. Then, downstream processes were developed to remove the aggregated antibodies. Thisrnpresentation will describe our strategies of resin screen and optimization for the removal of antibody aggregates.
GE Healthcare Life Sciences Cell Culture, USA
Time : 11:35-12:20
W G Whitford is Sr. Manager, Cell Culture, GE Healthcare in Logan, UT with over 20 years’ experience in biotechnology product and process development. He joined therncompany 13 years ago as a Team Leader in R&D developing products supporting biomass expansion, protein expression and virus secretion in mammalian and invertebraterncell lines. Products he has commercialized include defined and animal product-free hybridoma media, fed-batch supplements, and aqueous lipid dispersions. An invitedrnLecturer at international conferences, he has published over 250 articles, book chapters and patents in a number of fields in the bioproduction arena. He now enjoys suchrnindustry activities as serving on the editorial advisory board for BioProcess International.
New approaches in upstream bioproduction include applications of intensified biomanufacturing in both batch and continuousrnculture. Such high cell-density perfusion-supported formats can significantly change basic culture parameters resulting inrnaltered culture media circuits as well as production-cell demands and performance. And, there are a number of distinct highrncell-density, perfusion-based process and instrumentation styles available. Brand new manufacturing approaches including 3Drnbioprinting are creating entirely new demands for their inks, media and matrices. The advanced production platforms of multiplyrnrecombinant null CHO cells and new avian lines are requiring their own specialized SFM formulations. These, as well as such newrntherapeutic products as stem and CAR T-cell therapies all contribute to growing biologic, business and physicochemical demandsrnupon culture media and buffers. Media development strategies must consider such new product and culture mode-unique demandsrnupon primary metabolites and growth factors; media volumes, schedules and storage; materials cost and even definitions of qualityrnattributes. Beyond this, heightened standards for raw and ancillary materials (including single-use product-contact plastics) inrnbiomanufacturing are rising from a number of factors. These include improved assays and testing equipment; model risk-basedrnapproaches adapted from other fields and developing specifications from consortiums and standards-setting bodies.