PepTalk 2017
PepTalk 2017
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Cambridge Healthtech Institute’s Third Annual
Detection and Characterization of Particulates and Impurities
Rapid Tools and Strategies for Risk Assessment, Prediction and Characterization of Particles and Impurities
from Products, Excipients and Processes

January 10-11, 2017 | Hilton San Diego Bayfront | San Diego, CA


Particles and impurities can come from the products, any stage of bioprocessing, or the delivery devices and primary packaging, and they have potential to impact stability, safety, and efficacy of the biomolecules and biologic products. Therefore, early understanding, detection and characterization of the impurities are critical to ensure safety and efficacy of the drug product for its intended duration of use. The Third Annual Detection and Characterization of Particulates and Impurities conference provides a platform to explore novel tools and strategies to detect, characterize and carry out risk assessment of particles and impurities.

We invite you to present a poster and attend to join colleagues in this discussion of the key challenges and solutions for prediction, characterization, and risk assessment of particles and impurities from products and processes.


Sunday, January 8

4:00 - 5:30 Short Course Registration

5:00 - 8:00 Dinner Short Courses*

Recommended Course: (SC2) A Modern Approach to Biologics Formulation Development - Detailed Agenda

* Separate registration required

TUESDAY, JANUARY 10

1:00 pm Conference Registration

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

REGULATORY GUIDANCE, REFERENCE STANDARDS AND CONTROL

2:00 Chairperson’s Opening Remarks

Mehrshid Alai, Ph.D., Head, Global RA CMC (interim), Regulatory Affairs, Shire


Keynote Presentation

2:05 Regulatory Requirements and Guidance on Particles and Impurities for Late Stage Submissions

Mehrshid_AlaiMehrshid Alai, Ph.D., Head, Global RA CMC (interim), Regulatory Affairs, Shire

The regulatory concern on particles and impurities is an evolving topic. The expectations from regulatory agencies are increasing and it is important to ensure they are adequately addressed for a successful submission. In this presentation, we will examine some key regulatory guidance documents, as well as compare and contrast expectations from some key regulatory agencies. Some strategies around dealing with regulatory requirements in late stages of development will be discussed.

2:45 Detection of Impurities: Use of Pharmacopeia Reference Standards

Fouad Atouf, Ph.D., Director, Global Biologics, United States Pharmacopeia (USP)

This presentation will provide an overview of the type of reference standards (RSs) provided by the United States Pharmacopeia, specifically the RSs used to detect and measure impurities. Information on characterization of these materials as well as data to support their suitability for use will be presented. Cases studies from simple peptide molecules to complex biological preparations will be discussed.

3:15 Sponsored Presentation (Opportunity Available)

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

DETECTION AND CHARACTERIZATION OF PROCESS-RELATED IMPURITIES

4:30 LCMS Detection of the Residual Peptides from Yeast Extract and Hypep in In-Process Samples of Biotherapeutical Drug Substance

Guifeng_JiangGuifeng Jiang, Ph.D., Senior Manager, Analytical Science, Boehringer Ingelheim

Some peptides from yeast and soy proteins may be immunogenic, raising safety concerns. Health authorities expect data showing clearance of the components of yeast/Hypep hydrolysates during the downstream purification process to be included in the BLA. A reverse phase liquid chromatography with high resolution mass spectrometry method was developed to separate and detect components of the Yeast extract/Hypep and to demonstrate the clearance of the components during the purification process.

5:00 Sources, Detections and Control Strategies of Beta-Glucan Impurity in Biopharmaceutical Manufacturing Processes

Jinshu_QiuJinshu Qiu, Ph.D., Principal Scientist, Process Development, Amgen

(1-> 3)-β-D-glucans (beta-glucans) are a process-related impurity arising from raw materials used in biopharmaceutical manufacturing processes. Beta-glucans can be an indicator of invasive fungal infection or modulate an innate immune response, therefore their presence in drug products may pose a potential safety concern unless controlled below safety limits. Hence, it is critical to ensure their clearance during manufacturing. Beta-glucan sources, detections, and control strategies will be discussed in the presentation.

5:30 Close of Day


5:30 - 5:45 Short Course Registration

5:45 - 8:45 Dinner Short Courses*

Recommended Course: (SC8) Next-Generation Sequencing of Antibody Libraries: Details on Experimental and Bioinformatic Methods - Detailed Agenda


* Separate registration required

WEDNESDAY, JANUARY 11

8:00 am Conference Registration and Morning Coffee

ANALYZING AND MANAGING HOST CELL PROTEIN IMPURITIES

8:30 Chairperson’s Remarks

Qingchun Zhang, Ph.D., Senior Scientist, Attribute Sciences, Amgen


FEATURED PRESENTATIONS

8:35 What We Learned from MS-Based HCP Analysis

Qingchun Zhang, Ph.D., Senior Scientist, Attribute Sciences, Amgen

Host cell proteins are important process-related impurities for biologics. A mass spectroscopy based HCP analysis approach and its applications will be discussed.

9:05 Host Cell Protein (HCP) Control Strategy Reassessment for a CHO-Derived Protein Therapeutic

John_RolfJohn Rolf, Ph.D., Director, Corporate Quality, Product Quality Leader, Amgen

Immunoassay tests are standard to establish HCP impurity specifications and monitor protein therapeutic lot-to-lot consistency. However, multi-analyte Immunoassay tests may over- or under-quantify. xhsngIn this case study, Mass Spectroscopy (MS) identified and quantified individual HCPs from protein product drug substance, comparing results to the Immunoassay. The case study demonstrates how MS testing (and supplemental characterization data) was used to redefine the HCP control strategy – without impacting product or patient safety.

9:35 Sponsored Presentation (Opportunity Available)

10:05 Coffee Break in the Exhibit Hall with Poster Viewing

10:50 Specific Immune Response to a Host Cell Protein Impurity

Sally Fischer, Ph.D., Principal Scientist, BioAnalytical Sciences, Assay Development and Technology, Department of Development Sciences, Genentech

A product related impurity was identified in the material used in clinical study. To assess the potential ability of patients to develop an immune response to the impurity and impact on immunogenicity of the therapeutic two bridging ELISA were developed and validated. Samples from treated subjects were evaluated in both assays. This presentation will discuss the results of the immunogenicity assessment to the impurity and observed immunogenicity rate of the therapeutic.

11:20 Assessing Immunogenicity Risk in Biotherapeutic Product and Process Development

Valerie_QuarmbyValerie Quarmby, Ph.D., Staff Scientist and Director, BioAnalytical Sciences, Genentech

Every biotherapeutic has the potential to elicit unwanted immune responses, and these may compromise safety and efficacy. Several approaches can be used during lead selection and optimization to assess the likelihood that a biotherapeutic may be immunogenic. Some of these may also be used to assess immunogenicity risk from product variants or process related impurities. This talk will review immunogenicity risk assessment systems in the context of process development.

11:50 PANEL DISCUSSION: Establishing Relationship of Impurity to Potency and Activity and How They Affect Patients, Storage and Shelf Life

Moderator:

Sally Fischer, Ph.D., Principal Scientist, BioAnalytical Sciences, Assay Development and Technology, Department of Development Sciences, Genentech


Panelists:

Valerie Quarmby, Ph.D., Staff Scientist and Director, BioAnalytical Sciences, Genentech

Qingchun Zhang, Ph.D., Senior Scientist, Attribute Sciences, Amgen

John Rolf, Ph.D., Director, Corporate Quality, Product Quality Leader, Amgen

12:20 pm Sponsored Presentation (Opportunity Available)

12:50 Session Break

1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

CRITICAL CONSIDERATIONS IN PRODUCT DEVELOPMENT: FORMULATION, STABILITY, PARTICLES AND PACKAGING

2:00 Chairperson’s Remarks

Wendy Saffell-Clemmer, MS, Director, Research, Pharmaceutical Development, Baxter Healthcare

2:05 Selection of Pre-Filled Syringe for Biologic Products on Particulate Matter and Product Stability – A Case Study

Wendy_Saffell-ClemmerWendy Saffell-Clemmer, MS, Director, Research, Pharmaceutical Development, Baxter Healthcare

Pre-filled syringes provide significant advantages to the clinician and the patient. However, the pre-filled syringe and syringe filling process can have a significant impact on particulate formation and product stability. Methodical laboratory studies on the formulation are needed to understand potential causes of particle formation. A case study describing development of a liquid monoclonal antibody pre-filled syringe product will be presented along with a discussion of manufacturing scale-up challenges.

2:35 Developing a Multi-Pronged Approach to the Identification of PS20 Degradation Mechanism

Anthony_TomlinsonAnthony Tomlinson, Senior Research Associate, Late Stage Pharmaceutical Development, Genentech

Polysorbates are commonly used non-ionic surfactants in protein pharmaceuticals. In recent years, there has been increasing concern in the degradation of these materials on long-term stability and the subsequent increase of insoluble degradation products. In this talk, we will discuss the detection of PS20 degradation products and the identification the mechanism of degradation for root cause analysis.

3:05 Subvisible Particles: Rapid and High-Throughput Tools for Prediction, Detection and Characterization of Subvisible Particles and Other Aggregates

Andrea_HaweAndrea Hawe, Ph.D., CSO, Coriolis Pharma

Aggregates and subvisible particles (SVP) are considered cQA for biologics, and it is crucial to include a comprehensive characterization early during drug product development. Especially, for early development a reduction of required time, material and resources is essential. Within the talk an overview of methods and strategies for SVP and aggregate analysis is given, with special focus on minimization of material requirements, increase in throughput and possibilities for prediction of stability.

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing

4:30 Prediction of Antibody Stability in Lyophilized Solids by Hydrogen Deuterium Exchange with Mass Spectrometric Analysis (HX-MS)

Kathleen_AbadieKathleen Abadie, Engineer I, Late Stage Pharmaceutical Development, Genentech

We explore HX-MS to study protein structure in lyophilized solids for deeper understanding of solid state stability and to save time and resources in pharmaceutical development. HX probes structure by measuring the frequency of stabilizing amide H-bonds. Indeed, we show that reduced stability as indicated by increased deuterium uptake versus time correlates with increased aggregation propensity. Stability effects of lyoprotectant concentration and processing conditions are assessed by HX-MS.

5:00 Scaled Down Containers for Protein Stability Studies

Eric Meinke, Ph.D., Senior Scientist, AstraZeneca Supply Biologics

Real-time, real-condition stability study is essential to establish the expiry of biological therapeutics. For drug substance, stability study is typically performed in small scale containers that mimic the actual storage container/condition at scale. A case study will be presented to highlight the criticality of understanding and controlling of the scaled down container for stability studies.

Buzz Sessions5:35 BuzZ Session B

Join your peers and colleagues for interactive roundtable discussions.

6:20 - 7:20 Reception in the Exhibit Hall with Poster Viewing

7:20 Close of Conference