Archived Content

Cambridge Healthtech Institute’s Inaugural
Advances in Purification Technologies
Advanced Technologies and Novel Concepts in Protein Purification
Part of CHI's 6th Annual The Bioprocessing Summit

August 21-22, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts


Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 

8:00 am Registration and Morning Coffee


NEW APPROACHES AND TECHNOLOGIES IN PURIFICATION CHROMATOGRAPHY (cont.)

8:25 Chairperson’s Remarks

Alois JungbaerAlois Jungbaer, Ph.D., Professor, Department of Biotechnology, University of Natural Resources and Life Science Vienna, (BOKU) and Austrian Centre of Industrial Biotechnology




8:30 Design and Optimization of Countercurrent Tangential Chromatography for Monoclonal Antibody Purification

Andrew ZydneyAndrew Zydney, Ph.D., Professor and Department Head, Chemical Engineering, The Pennsylvania State University

Countercurrent Tangential Chromatography (CTC) is a new column-free capture technology that enables fully disposable operation. Binding, washing, elution, stripping, and equilibration steps are conducted on a moving slurry pumped continuously through a cascade of static mixers and hollow fiber membrane modules. This talk will describe the analysis used to develop and optimize a CTC system for monoclonal antibody purification that provides comparable antibody yield and host cell protein removal with nearly 10-fold greater productivity than conventional packed columns.

9:00 Bench-Scale Development of a Multi-Column Continuous Protein A Affinity Process For mAb Biomanufacture

Anthony Grabski, Ph.D., Director, R&D, Semba Biosciences, Inc.

We tested multi-column continuous chromatography (MCC) protocols for Protein A affinity purification of monoclonal antibodies (mAbs). We will present results comparing various protocols and adsorbents for their productivity and efficacy in an 8-column MCC process. The relationship between mAb titer and productivity with MCC vs. the traditional batch process will be experimentally demonstrated.

9:30 An Intensified Refolding and Downstream Process for a Highly-Expressed Recombinant Protein in E.coli

Shuang ChenShuang Chen, Ph.D., Senior Scientist, Pfizer, Inc.





10:00 Mid-Morning Snack in the Exhibit Hall with Poster Viewing

10:45 A Non Protein-A Capture Step for mAbs Based on Selective Precipitation Combined with CEX

Danielle van WijkDanielle van Wijk, Ph.D., Project Leader, Downstream Processing, Synthon Biopharmaceuticals

A low cost and non toxic precipitation agent was used combined with a novel cationic (CEX) resin as the initial purification step. Several CEX resins were evaluated for binding capacity, selectivity and cleanability. The selected CEX resin has a significant increased capacity over protein A and data indicate a combined use of selective precipitation and CEX are promising for future “high” titer antibody purification processes.

11:15 Fast Track Process Development and Validation: Chromatographic High-Throughput Characterization - Is This the Solution for Process Development?

Matteo CostioliMatteo Costioli, Ph.D., DSP Process Development Manager, BioProcess Science, Merck Serono

To rapidly develop a safe, well controlled, efficient and cost effective process, the use of HTS combined with design of experiment, is key. A case study for a MAb of a fast track process development approach for a CEX step is discussed. A proposed characterization using micro- column in combination with a robotic liquid handling system and the ensuing scale-up to lab-scale is described. Implementation of a HTS in the new 3 stage process validation framework is also discussed.

11:45 Hydrophobic Interaction Chromatography Optimization Using Definitive Screening Design Versus Traditional Experimental Designs

Yi Li, Ph.D., Sr. Scientist, Biologic Process Development, Bristol-Myers Squibb

The optimization of hydrophobic interaction chromatography (HIC) can consume a considerable amount of material and time using traditional experimental designs. Definitive screening design (DSD) uses fewer experiments to identify significant factors to provide resolution between main effects, two-way interactions and quadratic effects. We optimized ten HIC parameters for protein recovery and aggregate clearance using high-throughput chromatography. Results show the robustness of DSD and important findings were confirmed.

12:15 pm High Throughput Optimization Approach for Single Step Polishing of Monoclonal Antibodies Post Protein A Capture

Ian Sellick, Director, Marketing, Pall Life Sciences





12:30 Enjoy Lunch on Your Own


TECHNIQUES AND STRATEGIES TO OVERCOME PURIFICATION AND CLARIFICATION CHALLENGES

1:25 Chairperson’s Remarks

Sophia T. Mundle, Ph.D., Senior Manager, Protein Chemistry, Sanofi Pasteur

1:30 Viral Clearance Challenges in mAb Development

Joe ZhouJoe Zhou, Ph.D., CEO, Genor Biopharma, Walvax Bio Group and Visiting Professor, Peking University





2:00 Clarification and Purification Techniques for High Density Mammalian Cell Cultures and Bacterial Fermentation

Kathryn Golden, MEng., Scientist II/Development Project Manager, Manufacturing and Process Sciences, Eleven Biotherapeutics

State-of-the-art upstream processes continue to push industry limits with increasingly concentrated cell densities and productivities in both mammalian cell culture and bacterial fermentation. Associated improvements in clarification and purification techniques are being designed to handle these challenging process streams. Two case studies of the development of high density upstream, clarification, and purification processes will be discussed.

2:30 Purification of the Sanofi Pasteur HSV2 Vaccine Candidate, HSV529

Sophia T. MundleSophia T. Mundle, Ph.D., Senior Manager, Protein Chemistry, Sanofi Pasteur

The Sanofi Pasteur replication defective HSV2 vaccine candidate, HSV529, can be purified by a method which includes a combination of harvesting without cell disruption, endonuclease treatment, depth filtration, anion-exchange chromatography and ultrafiltration/diafiltration (UF/DF). The resultant virus retains infectivity and is ∼ 200-fold more pure with respect to host cell DNA and proteins than is HSV529 purified by ultracentrifugation. Side-by-side comparison of chromatography-purified ACAM529 with sucrose cushion-purified HSV529 shows that both preparations are equally immunogenic and protective when tested in vivo.

3:00 Refreshment Break

3:15 High-Throughput Ion Exchange Purification of Positively Charged Recombinant Protein in the Presence of Negatively Charged Dextran Sulfate

Lam MarkelyLam Markely, Scientist II, Cell Culture Development – High-Throughput Analytical Group, Biogen Idec

We developed an SSP (small scale protein purification) using ion exchange resins to purify positively charged recombinant growth factor P1 in the presence of negatively charged dextran sulfate. The major challenge in this work is that strong ionic interaction between P1 and dextran sulfate disrupts interaction between P1 and chromatography resins. To solve this problem, we develop a two-step SSP using Q Sepharose Fast Flow (QFF) and SP Sepharose XL (SPXL) resins to purify P1.

3:45 Protein Glycosylation Selectivity in Chromatographic Separation

Alan ShupeAlan Shupe, Ph.D., Scientist I, Biologics Manufacturing and Process Development, Bristol-Myers Squibb

Variation in glycan components such as sialic acid exhibit different local charge density and hydrophobicity, and affect the purification performance. In this study we examine the separation behaviors of monomeric and high-molecular weight glycoforms in both ion-exchange (IEX) and hydrophobic interaction (HIC) chromatography. The interplay between IEX and HIC profiles becomes self-evident when analyzing all types of glycoforms together. This study illustrates some general aspects about how glycosylation heterogeneity can impact product quality and process yield.

4:15 Platform mAb Purification in the Age of Continuous Chromatography

Finn Hung, Ph.D., Senior Scientist, Merck & Co.

4:45 End of Conference


Suggested Short Course*

Accelerated Stability Testing of Biologics 

Tuesday, August 19, 6:00-8:30 pm


*Separate registration required


Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios