Lunch & Learn Seminars
Seminar Summary
All Breakfast & Learns + Lunch & Learns will be held in Golden Gate C2/3 located on Level B2 in the Marriott Marquis.
| Date | Time | Sponsor Host |
| Sun, Aug 13 | 12 – 2 pm | Purolite |
| Mon, Aug 14 | 7 – 8 am | NIIMBL |
| Mon, Aug 14 | 12 – 2 pm | Cytiva |
| Tues, Aug 15 | 7 – 8 am | Avantor Sciences |
| Tues, Aug 15 | 12 – 1 pm | Bio-Rad |
| Wed, Aug 16 | 12 – 1 pm | MilliporeSigma |
Seminar Details
Purolite: Advances in Protein A Chromatography Resins
Sunday, August 13 from 12 – 2 pm PST from Hans J. Johansson, Global Applications Director
Current trends in antibody-based therapeutics include the development of a variety of different atypical IgG constructs. While bispecific antibodies and Fc fusion proteins typically bind to Protein A, they are in many cases sensitive to the acid conditions typically used for elution from Protein A resins. There is thus increasing interest in resins capable of eluting IgG at milder pH conditions compared to current Protein A resins on the market.
The presentation will focus on the performance characteristics of a new Protein A resin that combines high capacity with the capability of elution at pH 5, with standard buffers.
NIIMBL: Update on NIIMBL
Monday, August 14 from 7 – 8 am PST from Kelvin H. Lee, Director of NIIMBL
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.
Cytiva: Designing purification strategies for bispecific antibodies based on molecule design
Monday, August 14 from 12 – 2 pm PST from Anna Grönberg, Staff Research Engineer
Developing purification protocols for multispecific antibodies present extra challenges compared to conventional therapeutic monoclonal antibodies (mAbs). Strategies for efficient capture and polishing are discussed already in antibody engineering. Strategies include available resins and methods and the need to give sufficient separation of product and process-related impurities.
This presentation covers different aspects of designing a GMP purification process for bispecific antibodies.
Avantor: A case study demonstrating effectiveness and advantages of detergent-based viral activation process
Tuesday, August 15 from 7 – 8 am PST from Nandu Deorkar, Senior Vice President of Biopharma Production Research and Development
The speaker Nandu Deorkar is Senior Vice President, Biopharma Production Research & Development for Avantor. He is responsible for innovation strategy and planning, and execution of new products and technology development.
Bio-Rad: Vector Purification Strategies for Gene Therapy
Tuesday, August 15 from 12 – 1 pm PST from Sharon Bola, MS Global Product Manager and Sushmita Koley, Ph.D., Senior Scientist
In recent years, gene therapy treatments have increased significantly requiring more efficient processes to purify and
deliver these therapeutics. Lentiviral vectors (LVV) and recombinant adeno-associated viruses (rAAV) are among the
most effective tools for gene delivery.
With the ability to deliver therapeutic genes to target cells, these vectors hold great
promise for treating genetic disorders and other diseases. In this workshop, we will discuss high-throughput screening strategies and downstream process development work for LVV purification using anion exchange chromatography resins. In addition, different chromatography purification solutions were explored to purify rAAV8. A mixed-mode chromatography resin was used to separate the empty capsid from full capsid with excellent yield and further removal of HCP and DNA. We will discuss the experimental conditions and the data of these vector purification workflows.
MilliporeSigma: Opportunities for process intensification for monoclonal antibody purification
Tuesday, August 16 from 12 – 1 pm PST from Akshat Gupta, Associate Director of Applications Engineering
While as an Industry we work towards enhancing our understanding of continuous processing in biopharmaceuticals, batch processes remain the mainstay for clinical and commercial monoclonal antibody production. In this work, we investigated process intensification opportunities that exist today for mAb purification.
We developed an intensified monoclonal antibody purification process leveraging best-in-class purification technologies offered by MilliporeSigma. In this lunch and learn seminar we will present harvest preconcentration-enabled intensified capture, intensified polishing via flowthrough polishing technologies, and intensified drug delivery by leveraging viscosity reduction platform, cassette feed channel designs, and Single Pass Tangential Flow Filtration (SPTFF).