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Cambridge Healthtech Institute’s 6th Annual

Detection and Characterization of Particulates and Impurities
( 微粒和杂质的检测和表征 )

Hot Topics, Emerging Contaminants and Impurities, Case Studies, and New Technologies

1月21日~22日

Part of the Analytics & Impurities pipeline

Cambridge Healthtech Institute’s 6th Annual Detection and Characterization of Particulates and Impurities conference will bring together leading researchers to discuss hot topics, emerging contaminants and impurities and new characterization tools for impurities that may come from various sources and stages of product development. Through new presentations, informative panel discussions, high-level poster presentations, and interactive breakout discussions, top scientists will share new insights into characterization and control of various impurities. Some of the hot topics for this year will be new and novel technologies for virus and pathogen detection, host cell proteins, lipases and enzymatic degradation, aggregations, leachable, chemistry and manufacturing controls (CMC) strategy for regulatory filings.

Final Agenda

1月21日(二)

1:00 pm Registration

1:30 Refreshment Break in the Exhibit Hall with Poster Viewing

Particles, Aggregates, and Stability

2:00 Chairperson’s Opening Remarks

Boxu Yan, PhD, Senior Director, Analytical Development and Quality Control, Acceleron Pharma

 

KEYNOTE PRESENTATION

2:05 Microfluidic Approaches for the Characterization of Biopharmaceuticals

Paolo Arosio, PhD, Professor, Biochemical Engineering, Department of Chemistry and Applied Biosciences, ETH Zurich

We highlight the emerging possibilities offered by advances in microfluidic technology for the analysis of therapeutic proteins during manufacturing and formulation. We discuss a diffusion microfluidic platform for the characterization of: a) polydisperse size distributions in the sub-micron range; b) sizes and interactions in solutions at high protein concentration; and c) specific interactions in complex mixtures.

2:45 Cell-Based FcgR Binding Assay for Sensitive Detection of Biologics Aggregates

Joel F. Cohen-Solal, PhD, Senior Scientist, Global Protein Sciences, AbbVie Bioresearch Center, Inc.

Low-affinity Fc gamma receptors of different species have the ability to specifically bind to immune complexes or IgG aggregates, thus acting as either physiological sensors or uptake receptors. We will review the literature and internal data showing that a cell-based FcgR binding assay is, therefore, the relevant assay to monitor the presence of physiologically active aggregates in biologics solution or in serum.

3:15 Sponsored Presentation (Opportunity Available)

3:45 Refreshment Break in the Exhibit Hall with Poster Viewing

4:30 Moving towards Harmonization in Subvisible Particle Measurements: Advanced Data Analytics and New Reference Standards

Richard Cavicchi, PhD, Research Physicist, Biomolecular Measurement Division, Material Measurement Laboratory, National Institute of Standards and Technology

Improved quantitative measurements of subvisible particles will require advanced analytic methods to relate measured quantities to particle attributes (e.g., an equivalent diameter). New NIST reference materials can help with calibration and validation of these measurements.

5:00 Insight into Process Development of Oligonucleotide/Polymeric Carrier Formulation

Rui Fang, PhD, Senior Scientist, Sterile Formulation Sciences, Merck & Co., Inc.

This presentation highlights investigations into formulation and process variables to understand the root cause of particle formation in an oligonucleotide/polymeric carrier formulation during manufacturing. Process variables that potentially lead to the failure were identified. Innovative approaches were applied to study pump pulsation. Predictive tools including CFD modeling and the 4th Bourne reaction were used to study mixing efficiency of the mixing chamber that potentially influences formulation composition and stability.

5:30 Close of Day

5:30 - 5:45 Short Course Registration

5:45 - 8:45 Recommended Dinner Short Course*

 

SC5: Protein Aggregation: Mechanism, Characterization, and Consequences

Instructors:

Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Kevin Mattison, PhD, Principal Scientist, Malvern Pananalytical, Inc.


*Separate registration required

1月22日(三)

7:45 am Registration and Morning Coffee

Surfactant-Related and Product Impurities

8:15 Chairperson’s Remarks

Paolo Arosio, PhD, Professor, Biochemical Engineering, Department of Chemistry and Applied Biosciences, ETH Zurich

FEATURED PRESENTATION

8:20 Human IgG1 Hinge Fragmentation as the Result of Radical Mediated Cleavage

Boxu Yan, PhD, Senior Director, Analytical Development and Quality Control, Acceleron Pharma

Hinge cleavage of a recombinant human IgG1 antibody is commonly observed from purified drug substance and in stability samples. The hinge cleavage was found initiated by radical-induced breakage of the disulfide bond between the two hinge cysteines. As hydroxyl radicals exist in healthy cells’ tissues and most buffer solutions, they could therefore be the source for the radical-induced fragmentation of human IgG1 antibodies in vivo.

8:50 Optimizing Protein-Surfactant Bulk and Interfacial Interactions through Advanced Characterization Techniques for Controlling Aggregation and Viscosity

Samiul Amin, PhD, Associate Professor, Chemical Engineering, Manhattan College

Excipients such as Polysorbate 20/80, Kolliphor can have significant impacts on bulk protein aggregation and interfacial protein structuring at both air-water and oil-water interaces. Mechanistic understanding of these interactions can only be gained through a combination of advanced characterization-interacial rheology, optical microrheology, LC-DLS, and Raman Spectroscopy. Critical new insights provided by these techniques will be provided.

9:20 Sponsored Presentation (Opportunity Available)

9:50 Coffee Break in the Exhibit Hall with Poster Viewing

10:35 Case Study: Formulation Strategies to Eliminate Polysorbate Degradation-Related Particle Formation

Sandy Wang, MSc, Engineer II, Pharmaceutical Development, Genentech

Polysorbate 20 degradation resulting in the formation of free fatty acids can lead to particles in mAb formulations. This presentation will discuss a case study where different approaches were taken to identify a particle-free formulation.

11:05 Opportunities and Pitfalls in the Characterization of Submicron Particles during Biologics Product Development

Danny K. Chou, PharmD, PhD, President, Biopharmaceutical Characterization and Formulation Development, Compassion BioSolution, LLC

The presentation will focus on how one can take advantage of the newly available technologies for submicron and microsized particles while avoiding potential pitfalls.

11:35 Monitoring Clearance of Lipase Host Cell Proteins during Biotherapeutics Process Development Using a LC-MRM Quantitation Method

Rachel Chen, Scientist II, Analytical Development, Biogen

Successful removal of host cell proteins (HCPs) is very important for biopharmaceutical product development to ensure product quality and safety. Recently, it has been demonstrated that certain lipases may be the cause for enzymatic degradation of polysorbate 20 and 80, which are common surfactants used in protein formulations. An LC-MS/MS method was developed to achieve a sub ppm quantitation level of three lipases. The method has been applied to monitor the clearance of lipases for various mAbs and fusion proteins under different downstream processes.

12:05 pm Session Break

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

1:15 Session Break


1:45 PLENARY KEYNOTE PANEL

R&D CHALLENGES IN AN ERA OF INNOVATION

 

The PepTalk Plenary Keynote Panel convenes a group of leading scientists working across novel therapeutic modalities and R&D technologies to explore the many challenges associated with discovering, developing, and advancing today’s novel biotherapeutics. The Panel, via a highly interactive format, encourages discussion among both the panelists and the audience members. Please come prepared with your questions and ideas for this spirited discussion.

  • Advances and challenges in expression and production for novel modalities
  • Implementing next-generation informatics: data collection, standardization, analysis, ML/AI, and considerations for IP landscape and protection
  • Implementing R&D and production capacity for gene and cell therapies – where are we heading?
  • Modality-specific challenges: multi-specifics for cancer, improving the ADC therapeutic window, improved safety and pharmacology, novel delivery/targeting
  • Preclinical and clinical development of drug combinations with focus in IO: How do we select the right combination dose so we can accelerate clinical development?

Moderator:

Mohammad Tabrizi, PhD, Senior Director, Pharmacology, Ascendis Pharma A/S

 

 

PANELISTS

Vijay Chiruvolu, PhD, Senior Vice President of Global Process Development - Cell Therapy, Kite Pharma, a Gilead Sciences Company

 

 

Edward Kraft, PhD, Senior Scientific Manager, Biomolecular Resources, Genentech

 

 

David E. Szymkowski, PhD, Vice President, Cell Biology, Xencor, Inc.

 

 

Alayna George Thompson, PhD, Senior Scientist I, Drug Discovery Science & Technology, AbbVie

 

 

3:05 Refreshment Break in the Exhibit Hall with Poster Viewing

Aggregates and Impurities in Gene Therapy Products

4:00 Chairperson’s Remarks

Mark Galbraith, PhD, Head, Quality Control and Analytical Sciences, Spark Therapeutics

4:05 Monitoring and Control of Aggregates and Impurities in Large Scale AAV Production

Mark Galbraith, PhD, Head, Quality Control and Analytical Sciences, Spark Therapeutics

Monitoring and control of aggregates and impurities are important for successful large-scale production of gene therapies. In this presentation, we will discuss various aggregates and different types of impurities that can be encountered in a large scale AAV production, what tools and techniques can be used to monitor and characterize them, consideration for setting specification, etc.

4:35 Characterization and Quantification of Empty and Full AAV Capsids

Qin Zou, PhD, Associate Research Fellow and Group Leader, Analytical Research and Development, Pfizer, Inc.

This presentation can highlight various analytical methods for AAV empty and full capsids and emphasize the proper use of analytical ultracentrifugation for this purpose. AAV empty and full capsids is a product-related impurity and a critical quality attribute. Careful consideration of using appropriate analytical techniques to control that is important for a successful product.

5:05 Analytical Solutions for AAV Manufacturing

Speaker to be Announced

5:35 Predicting Viral Clearance: DOE, HTS and AAV Case Studies Utilizing a Non-Infectious MVM Surrogate during Downstream Development

David Cetlin, Founder & CEO, MockV Solutions LLC

Viral clearance studies are expensive and logistically challenging. This presentation will highlight data from the use of a non-infectious MVM surrogate in a variety of downstream applications and processes.

6:05 - 7:00 Networking Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Detection and Characterization of Particulates and Impurities Conference

* 活动内容有可能不事先告知作更动及调整。

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