Cambridge Healthtech Institute’s 5th Annual

Detection and Characterization of Particulates and Impurities
( 微粒子及雜質的檢測和表徵分析 )



Cambridge Healthtech Institute’s 5th Annual Detection and Characterization of Particulates and Impurities conference will bring together leading scientists from biopharmaceutical industry, academia and government to discuss hot topics, case studies, new technologies, and strategies to carry out risk assessment and mitigation for impurities arising from products, excipients, processes and packaging. Through new presentations, informative panel discussions, high-level poster presentations, and interactive discussions, top scientists will share new insights into detection, characterization and control of various impurities. Some of the hot topics for this year will be new and novel technologies contaminant detection, host cell proteins, lipases and enzymatic degradation, particles and aggregates, leachable, chemistry and manufacturing controls (CMC) strategy for regulatory filings. We are looking for cutting edge tools, research findings and unpublished data to be featured at this forum.

Final Agenda


1:00 pm Registration

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

Risk of Immunogenicity Posed by Aggregates and Impurities

2:00 Chairperson’s Opening Remarks

Joël Richard, PhD, Vice President, Peptides, CMC & Engineering, Ipsen


2:05 Aggregates and Particulates in Protein Formulation: Orthogonal Characterization Methods for a Data-Based Immunogenicity Risk Assessment

Joël Richard, PhD, Vice President, Peptides, CMC & Engineering, Ipsen

Aggregation remains a considerable challenge in the manufacturing, stability behavior and delivery of liquid protein formulations. Orthogonal biophysical techniques make it possible to characterize protein structure alteration and the subsequent mechanism of formation of sub visible aggregates and particulates, which are among the most striking issues suspected to trigger immunogenic reactions upon repeated subcutaneous administration. Clinical impact regarding potential safety issues will also be discussed, as identified by regulatory agencies.


2:45 Qualification and Validation Methods for New Particle Counting Instruments

Dean Ripple, PhD, Leader, Bioprocess Measurements Group, National Institute of Standards and Technology

The increased use of new types of particle counting instruments, such as flow imaging, has raised questions on how these instruments may be qualified and measurement methods validated. I will discuss the use of standards and a variety of independent measurements and data analysis methods that can address these needs, over a size range from 100 nm to visible.

3:15 Analysis of Various Process- Related Impurities by HPLC with Detection by ELSD, CAD or Fluorescence

Mario Dipaola, PhD, Senior Scientific Director, Biologics, Charles River Laboratory

During this presentation, several HPLC methods with varying detection methods will be discussed along with performance of these methods with respect to critical parameters such as LOD/LOQ/linearity range, etc. At least one case study will be presented, as well, to highlight some of the common challenges one is likely to face when developing a method for process residual testing.

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

Characterization of Subvisible Particles in Protein and Viral Vaccines

4:30 Title to Be Announced

Marina Kirkitadze, PhD, Deputy Director, Head of Biophysics and Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur, Canada

The topic of this presentation is characterization of visible and subvisible particles in protein and viral vaccine formulations. Visible and subvisible particles were found to be inherent to the product, and were analyzed by several methods including MFI, DLS, and MS.

5:00 New Tools and Strategies for Characterization of Particles in Biologics

Andrea Hawe, PhD, CSO, Coriolis Pharma Research GmbH

Particles in the nanometer and micrometer size range need to be characterized as part of drug product development, both as impurities (e.g. protein aggregates, polysorbate degradation) and as active (e.g. virus, cells). An overview on innovative methods for micrometer particles (backgrounded membrane imaging, imaging flow cytometry, etc.) and nanometer particles (resistive pulse sensing, novel flow imaging set-ups, etc.) will be given, including a critical comparison to existing methods.

5:30 Close of Day

5:30 - 5:45 Short Course Registration

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

SC3: Protein Aggregation: Mechanism, Characterization and Consequences

Click here for more details.

*Separate registration required


7:45 am Registration and Morning Coffee

Detection, Characterization and Control of Process- and Product-Related Impurities

8:15 Chairperson’s Remarks

Reza Nejadnik, PhD, Laboratory Head Formulation Development Biologics, Global Pharmaceutical Development Biologics, Sanofi

8:20 USP Standards for Monitoring Impurities in Biotherapeutics

Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

The complexity of biotherapeutic products and manufacturing processes can yield a variety of impurities, including process-related impurities, such as host cell protein, host cell DNA and particulates, and product-related impurities, such as precursors, aggregates and degradation products. These impurities must be monitored and controlled to minimize safety concerns and ensure product quality. This presentation will provide an overview of approaches for monitoring impurities, including specific examples that leverage USP standards.

8:50 Handling of Biologic Drug Products and Stability Challenges

Reza Nejadnik, PhD, Laboratory Head Formulation Development Biologics, Global Pharmaceutical Development Biologics, Sanofi

Although the pharmaceutical biotech industry has made great progress in improving bulk and drug product manufacturing as well as company-controlled storage and transportation conditions to minimize the level of product degradation, there is little control over the many factors that may affect product quality after the protein pharmaceuticals are released and shipped by the manufacturer. Routine handling or unintentional mishandling of therapeutic protein products may cause degradation that can potentially compromise the clinical safety and efficacy of the product.

9:20 Sponsored Presentation (Opportunity Available)

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

10:35 The Benefits and Risks of Using Croda Super RefinedTM Polysorbate 20 over TweenTM 20 HP

Nidhi Doshi, MSc, Senior Research Associate, Late Stage Pharmaceutical Development, Genentech

Super Refined Polysorbate 20 (SR PS20) and Tween 20 HP (HP PS20) are two grades of Polysorbate 20 from Croda. Detailed side-by-side evaluation of the two grades revealed some benefit of using SR PS20 over HP PS20 for particle formation risk upon surfactant degradation. However, SR PS20 formulations showed faster protein oxidation and PS20 degradation (by oxidative mechanism) compared to HP. This talk will weigh the benefits and risks of using SR PS20 over HP PS20 and provide recommendations on when to use one versus the other.

11:05 Comparison of Automated Methods for Quantitation of Host Cell Proteins

Jamie Rusconi, PhD, Staff Scientist, Bioanalytical Method Development, Regeneron Pharmaceuticals, Inc.

11:35 Strategy on Raw Material Impurities

Jinshu Qiu, Principal Scientist, Amgen

Large numbers of raw materials are used for manufacturing biopharmaceuticals. Appropriate control strategies are needed to mitigate the risks of these raw materials. The toxicity of the raw materials, the quantities used, point of introduction in the process, the product’s stage of development, the dose, and route of administration are important considerations. In this talk, tools for assessing the risks and developing the appropriate control strategies will be discussed.

12:05 pm Session Break

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

1:15 Session Break


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PepTalk Perspectives: Point-Counterpoint Discussions

Howard Levine, PhD, President and CEO, BioProcess Technology Consultants

Zhimei Du, PhD, Director, Bioprocess & Clinical Manufacturing, Merck

Lorenz Mayr, PhD, CTO, GE Healthcare Life Sciences

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

Excipients and Impurities in Pre-Filled Syringes and Freeze-Dried Formulations

4:00 Chairperson’s Remarks

Gregory A. Sacha, PhD, Senior Research Scientist, Baxter Healthcare Corporation

4:05 Impact of Silicone Oil on Fatty Acid Solubility and Polysorbate Related Particle Formation

Raphael Fish, Engineer I, Process Development, Genentech

Silicone oil coating on the interior of pre-filled syringes may act as a sink for fatty acids that are released upon hydrolytic degradation of polysorbates, potentially reducing risk of particle formation. Free fatty acids were shown to partition from an aqueous to a silicone oil phase in a glass vial model. However, the partitioning effect was not large enough to translate to significant reduction in particle formation risk at representative conditions. It was concluded that silicone oil levels in a PFS are too low to have any meaningful impact on polysorbate related particle formation.

4:35 Protein Crowding in Solution, Frozen and Freeze-Dried States Studied by Small-Angle Neutron Scattering

Susan Krueger, PhD, NIST Center for Neutron Research, National Institute of Standards and Technology

Small-angle neutron scattering is uniquely qualified to study the structure of proteins in liquid and solid phases that are biotechnologically relevant. We have studied a model protein, lysozyme, in the liquid, water ice and powder phases to determine its gross-structure, interparticle interactions and other properties. We also tested the effects of stabilizing excipients such as trehalose, glucose and sorbitol. Our results were compared to those from similar studies on antibodies.

5:05 Phase Behavior of an Alternative Surfactant, Poloxamer, during Freeze-Drying

Evgenyi Shalaev, PhD, Executive Director, Pharmaceutical Development, Allergan, Inc.

Poloxamers (e.g., P188) have been recently considered as alternative surfactants to polysorbates (tween20 and 80), as the latter are easily oxidized and can also undergo hydrolysis. In this study, complex phase behavior of aqueous solutions of a poloxamer is investigated using DSC, small-angle neutron scattering, and small- and wide-angle X-ray scattering.

5:35 The Effect of Co-Solvent Systems on the Drying Behavior of Common Excipients

Gregory A. Sacha, PhD, Senior Research Scientist, Baxter Healthcare Corporation

Many small molecules are poorly soluble in water and are often prepared in a co-solvent system prior to lyophilization. The co-solvent system may contain water and an organic solvent. This study examined the removal of the organic solvent from common excipients during primary drying using a residual gas analyzer. The drying behavior of amorphous and semi-crystalline formulations were examined as a function of organic solvent concentration.

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

* 活動內容有可能不事先告知作更動及調整。

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