The Bioprocessing Summit
The Bioprocessing Summit

Cambridge Healthtech Institute’s 3rd Annual
Advances in Purification Technologies
Economics and Efficiencies for Next-Generation Biomanufacturing 
Part of CHI's 8th Annual The Bioprocessing Summit

August 17-18, 2016 | Westin Boston Waterfront | Boston, Massachusetts


When asked what are the key themes being discussed at their internal meetings, the downstream scientists unanimously stated "process integration" and "process intensification". How can we integrate the processes to eliminate bottlenecks and downtime? How can we intensify the process to reduce purification steps, achieve higher productivity and lower COGS?

The 3rd Annual Advances in Purification Technologies conference delivers new trends in downstream processing, new strategies and approaches to purification of novel and complex molecules, as well as new advances and updates in technologies and equipment.

Final Agenda

Day 1 | Day 2 | Short Courses | Download Brochure


TUESDAY, August 16


6:00 – 8:30 Recommended Dinner Short Course*
SC7: Purification of Advanced Medicine Therapy Products

* Separate registration required


Wednesday, August 17

7:00 am Registration Opens and Morning Coffee

8:05 Chairperson’s Opening Remarks

Christoph Brandenbusch, Ph.D., Group Leader, Department of Biochemical and Chemical Engineering, Laboratory of Thermodynamics, TU Dortmund University


KEYNOTE SESSION

8:15 From Purification to Vaccine Development: A Challenging but Rewarding Journey

YanPing_YangYan-Ping Yang, Ph.D., Head, Bioprocess R&D North America, Sanofi Pasteur

The vaccine industry has high risk, long cycle time, and requires approximately 12 years bringing a product from pre-clinical to licensure at a cost of ~$1 billion. Purification of vaccine candidates to achieve consistent product purity and quality in a timely manner is an integral part of vaccine product development process. This presentation focuses on the applications of cutting edge purification technologies to facilitate vaccine process development and move faster to clinical evaluations.

9:00 Positioning Downstream Processing to Successfully Conquer Future Challenges

John Pieracci, Ph.D., Director, Purification Development, Biogen

The talk would include challenges the biotech industry is facing in the future (new modalities, price pressures, nimbly supplying small and large markets, etc.), building platform downstream processes for new modalities (antisense oligonucleotides, gene therapy, bi-specific mAbs, etc.), and the criticality to drive down CoGs to meet the pressures of large indications/markets and governmental forces by leveraging new technologies or driving up the productivity of existing processes.


DEFINING DESIGN SPACE

9:30 Defining Process Design Space for a Multimodal Chromatography Purification Step by Custom Design

Jie_ChenJie Chen, Ph.D., Senior Scientist, Process Development, Bristol-Myers Squibb

A process characterization study was performed to gain understanding of the multimodal chromatography (MMC) purification process and to map the design space. Seven factors out of thirty-eight process parameters were identified to be important. Custom design was employed to study multi-dimensional combination of operational variables for mapping of the process design space. A robust operating window was identified for this multimodal chromatography process that enabled sufficient impurity removal while ensuring acceptable process yield.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


CONTINUOUS AQUEOUS TWO-PHASE EXTRACTION

10:45 Continuous Aqueous Two-Phase Extraction of Proteins Part I – Estimating Process Windows and Industrial Applicability

Christoph_BrandenbuschChristoph Brandenbusch, Ph.D., Group Leader, Department of Biochemical and Chemical Engineering, Laboratory of Thermodynamics, TU Dortmund University

Increasing product titers in pharmaceutical protein production lead to a demand for novel workup strategies (eg: protein extraction by Aqueous 2-Phase System). However the effort and costs required in selecting appropriate ATPS and the determination of process windows hinders the industrial applicability. To enable estimations on the applicability of this workup strategy, hybrid ShortCut models to calculate partition coefficients have to be available.

11:15 Continuous Aqueous Two-Phase Extraction of Proteins Part II – Separation Principle and Novel Techniques

Gerhard_SchembeckerGerhard Schembecker, Ph.D., Professor, Biochemical and Chemical Engineering, TU Dortmund University

Aqueous Two Phase Extraction (ATPE) offers a gentle and biocompatible environment to separate industrially interesting enzymes from complex mixtures. The presentation will introduce the separation principle and existing and novel techniques will be discussed particularly in the light of continuous operation. Besides single and multi-stage mixer settler setups innovative processes immobilizing one of the two aqueous phases either in the pores of particles or by use of a centrifugal force fields will be investigated.

11:45 Amsphere A3: The Relationships and Considerations of Bead and Pore Structure, Surface Chemistries, and Ligand Design on Affinity Resin Performance

Satoshi Nakamura, Ph.D., Senior Research & Application Scientist, JSR Life Sciences

Industry needs, patent expirations of ligand design and market dynamics have accelerated the development and availability of many protein affinity resins. Technology providers must consider a range of design parameters such as resin backbone, bead size, pore size, surface chemistry modification, ligand construct and how they relate to performance criteria such as DBC, life time, caustic stability, and column packing among others. JSR’s approach to designing Amsphere A3™ affinity resin will be discussed. The balance between resin design and resin performance will be illustrated through a case study.

12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:00 Session Break


IMPROVEMENTS IN CHROMATOGRAPHY & ANALYTICAL TECHNIQUES FOR PURIFICATION

1:45 Chairperson’s Remarks

Yan-Ping Yang, Ph.D., Head, Bioprocess R&D North America, Sanofi Pasteur

1:50 Creating an Efficient Biopharmaceutical Factory: Protein Purification Using a Self-Cleaving Split Intein

Merideth_CooperMerideth Cooper, MSc, Chemical and Biomolecular Engineering, Ohio State University

Although affinity tags are commonly used in laboratory settings, tagged proteins cannot be used as therapeutics because of the potential immunogenicity of the tag. In this work, we describe a novel self-cleaving tag technology, based on a highly modified split-intein cleaving element. This approach is convenient and effective for the purification of traceless target glycoproteins from mammalian cell culture, and is currently being applied in a BioMOD platform device for on-demand biologics production.

2:20 The PA Tag Toolbox Offers a System for Easy Affinity Isolation, Robust Detection, and Recyclable Immobilization of High-Value Target Proteins

Junichi Takagi, Ph.D., Professor, Institute for Protein Research, Osaka University

We recently developed a novel and versatile epitope tag system dubbed “PA tag”. It is a dodecapeptide tag recognized by an antibody NZ-1, with a characteristic slow dissociation kinetics. PA tag enables purification, detection, and stable and reversible capturing of high value target proteins produced in mammalian cells. We also find that the PA tag can be “inserted” into a protein domain, which adds unique advantage over the existing tagging systems.

2:50 Application of Negative Mode Expanded Bed Chromatography to Improve Filtration-Based Washing Strategies of Human Mesenchymal Stem Cell.

Barbara Cunha, MSc, Animal Cell Technology, iBET – Instituto de Biologia Experimental e Tecnologica

The use of human mesenchymal stem cells (hMSC) in autologous and allogeneic therapies has been increasing over the last decade. To be applied in a clinical setting, hMSC need to comply with specific requirements in terms of identity, potency and purity. This talk will focus on the improvement of established tangential flow filtration-based washing strategies, by increasing hMSC purity, using negative mode expanded bed adsorption (EBA) chromatography with a new multimodal prototype matrix based on core-shell bead technology.

3:20 Accelerating Bispecific Drug Discovery Using Enhanced Purification and Analytical Techniques

Daniel Yoo, Scientist, Biologics, Amgen

Isolating high quality proteins from other undesired byproducts of expression, including aggregates, half antibodies, homodimer molecules, and mispaired species, poses significant purification challenges due to the similarities in physical properties of these molecules. Here, I present strategies we have explored to accelerate bispecific drug discovery using a combination of higher throughput screening, automated sample handling, and enhanced purification and analytical techniques to identify higher quality therapeutic candidates.

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing


4:45 Plenary Keynote Session - click here for details


6:00 Networking Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day

Day 1 | Day 2 | Short Courses | Download Brochure


Thursday, August 18

8:00 am Registration Opens and Morning Coffee


PURIFICATION OF EMERGING BIOMOLECULES

8:25 Chairperson’s Remarks

Guy de Roo, Ph.D., Project Leader, Downstream Processing, Synthon BV


8:30 KEYNOTE PRESENTAITON:
Development and Manufacturing of MCLA-128 and MCLA-117 Biclonics® Common Light Chain Bispecific Antibodies

Lex_BakkerLex Bakker, Ph.D., Senior Vice President & CDO, Merus Biopharmaceuticals

MCLA-128 is an ADCC-enhanced bispecific IgG1 antibody targeting HER2 and HER3. MCLA-117 is a T cell engaging bispecific antibody targeting CD3 and CLEC12A, a novel AML-associated antigen. MCLA-128 and MCLA-117 are produced using Merus’ proprietary CH3 heterodimerization technology. Both Biclonics® product leads are manufactured using IgG1 platform approaches.


9:00 Purification of Viral Particles

Yingxia Wen, Ph.D., Head, Protein Biochemistry, Seqirus

9:30 Sponsored Presentations (Opportunities Available)

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Process Development of the Antibody-Drug Conjugate (ADC) SYD985 - A Case Study

Guy de Roo, Ph.D., Project Leader, Downstream Processing, Synthon BV

SYD985 is an antibody-drug conjugate (ADC) based on trastuzumab and a cleavable linker-duocarmycin payload. A case study will be presented in which a hydrophobic interaction chromatography (HIC) purification process was developed allowing removal of the undesired antibody species together with unbound linker-drug. It was possible to elute the product (SYD985) using mild conditions without requirement for any organic solvent. The HIC purification step was scaled up, demonstrating consistency and robustness.

11:15 Separation of Half-Antibodies during the Purification of Bispecific Antibody

Ray Low, Ph.D., Scientist, Biologic Optimization/R&D, Amgen

The strong hydrodynamic similarity between half antibodies and whole antibodies mitigates their separation in a single purification step without major product loss. In this presentation, I will discuss the solution behavior of a half-antibody and demonstrate how such behavior can be exploited to separate it from a whole antibody.

11:45 Navigating the Downstream Processing Challenges for Novel Monoclonal and Bispecific Antibodies

Chen_WangChen Wang, Ph.D., Principal Scientist, Process Sciences, Abbvie Bioresearch Center

As we expand our biotherapeutic product portfolio, significant processing limitations have arisen with the existing platform for some of the novel monoclonal and bi-specific antibodies such as dual variable domain immunoglobulins (DVD-IgsTM). Through exploring unconventional chromatographic methods, adopting state-of-the-art purification technologies and understanding protein-protein interaction mechanism, we were able to develop effective strategy and toolbox to overcome processing challenges for molecules with platform fit concern.

12:15 Lunch Available for Purchase in the Exhibit Hall

1:15 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing

1:55 End of Conference



Day 1 | Day 2 | Short Courses | Download Brochure