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Key Sessions

Keynote: New insights from FDA on Data Integrity

Keynote: Staying in Control: How the Right Analytical Methods Drive the Right Control Strategies

8:15 am 8:30 am (15 mins)

Opening Remarks

8:30 am 9 am (30 mins)

Keynote: New insights from FDA on Data Integrity

9 am 9:30 am (30 mins)

Keynote: Staying in Control: How the Right Analytical Methods Drive the Right Control Strategies

Analytical methods ultimately drive control strategies. The analytical component allows you to truly understand and evaluate, and understand your processes. During this insightful keynote we will discuss methods for putting together the right control strategies in the right places, considerations for limiting container testing, and strategies for delivering a consistent product at the time of manufacture.  

9:30 am 10 am (30 mins)

Semi-automated, Mass Spectrometric Determination and Evaluation of Glycosylation CQAs at the Bioreactor Level

The industrial manufacturing of a monoclonal antibody is generally preceded by a process development phase.  During this time, it is crucial to achieve sufficient understanding of the design-space and its impact on the product specifications.  Mass spectrometry is a powerful tool for the monitoring of critical quality attributes related to a typical bioproduction, however, fully integrated analytical platforms have been elusive,

We present here a standalone analytical platform developed for the direct connection of a bioreactor to an MS system, for real time, at-line, monitoring of mAb CQAs.

  • Jason Wood, PhD., Bruker Daltonics Inc.

9:30 am 10 am (30 mins)

Workshop # 2

10:30 am 11 am (30 mins)

NEW DATA/CASE STUDY- Overview of Analytical Characterization Methods used to Demonstrate Comparability of Human Papillomavirus Containing Vaccines

ICH Q5E recommends that changes to manufacturing processes be evaluated via comparability to ensure the quality, safety and efficacy of drug product. Comparability evaluations can be performed by comparing assay results against predefined acceptance criteria/alert levels without requiring clinical trials. A case study focusing on characterization assays performed for the assessment of comparability of Human Papillomavirus vaccines will be presented.

This talk will provide insight into the comparability strategy and characterization methods used to successfully license process changes to Human Papillomavirus vaccines without clinical trials.

  • Carol Shultz, PhD., Merck & Co.

10:30 am 12 pm (90 mins)

New Data from NIH on Assay Development Strategies for Vaccines

  • Jonathan Cooper, PhD. , Vaccine Research Center/NIAID/NIH

11 am 11:30 am (30 mins)

Analytical Characterization and Potency Assays for Vaccines

  • Goutam Sen, PhD., Food and Drug Administration, Center for Biologics Evaluation and Research, (CBER)

2 pm 2:30 pm (30 mins)

NEW DATA- Integrated Methods for Fingerprint Analysis of Recombinant Proteins

There is much interest in the development and implementation of “fingerprinting” of proteins.  This has been driven by the introduction of biosimilars. As described, the fingerprint assesses a number of product attributes in a sensitive manner using orthogonal methods.  We demonstrate the use of 2D LC hyphenated to MS and other assays as a viable platform to assess multi-attribute parameters.

  • Darryl Davis, PhD., Janssen R&D LLC

2:30 pm 3 pm (30 mins)

NEW DATA/CASE STUDY- Analytical Methods for the Characterization of Glycated Monoclonal Antibodies

Glycation is a common post translational modification in monoclonal antibodies that may impact biological activity of the monoclonal antibodies. Therefore having appropriate characterization assays in place is important to maintain consistency and quality of product delivered to patient.

We report the case studies of mAbs in the presence of reducing sugars, conditions that result in glycation, and techniques used to characterize these samples. Typically, glycation may be detected by standard assays such as reduced CE-SDS and boronate affinity chromatography (BAC). The glycated species are enriched by BAC and characterized by CE-SDS. Glycated mAbs showed a wider light chain and heavy chain in the reducing CE-SDS profile and specifically the glycated light chain eluted as a post light chain shoulder. We also discuss the utility of other assays in characterizing glycated mAbs.

  • Soundara Soundararajan PhD., Merck & Co.

1:30 pm 2 pm (30 mins)

Development of Bioassays for T-cell Dependent Bispecific Molecules

T-cell dependent bispecific antibodies (TDBs) are able to recruit and activate host T-cells to kill the cancer cells. There are traditional bioassays available to measure T-cell activation such as PBMC-based methods, FACS-based methods, and ELISA with secreted cytokines, but unfortunately most of them are highlyvariable and/or time consuming. Here we present our bioassay strategy forT-cell dependent bispecific molecules. We will cover potency assay strategyusing reporter cell lines and bridging binding assay format. T-cell activation assay detecting a CD3 homodimer and other impurities activating T-cell intarget-independent ways will be discussed as well. Our assay formats are MoAreflective, and were found to be accurate, precise and user-friendly with short assay turn around time. These assays are being further assessed for their suitability for use in support of lot release testing and process impurity testing.

  • Dr. Ho-Young Lee, Genentech

3:30 pm 4 pm (30 mins)

Regulatory Guidance for Bioassay Development and Validation

3:30 pm 4 pm (30 mins)

Phase Appropriate Stability and Comparability Strategies to Accelerate Introduction of New Modalities into the Clinic

With the advent of new modalities, particularly in the oncology space, it is increasingly important to accelerate their introduction into the clinic. However, these modalities are not well-understood and come with their unique process development and stability challenges. In this talk, case studies will be highlighted that explain how elements of well-established monoclonal antibody practices can be leveraged for these new modalities such as bispecific T-cell engagers. In addition, phase appropriate strategies will be articulated, including early candidate selection, toxicology and GMP production, as well as overcoming stability and comparability challenges.

  • Dr. Ranjini Ramachander, Amgen Inc

4 pm 4:30 pm (30 mins)

NEW DATA/CASE STUDY- Impact of Drug Product Configurations and Components on Subvisible Particle Counts of a mAb

Drug product container closure components have been shown to potentially impact quality attributes of biopharmaceutical products.  Silicone oil is typically coated onto components to aid in manufacturability and for ease of use, however, it has also been implicated in expediting aggregation and sub-visible particle formation under various stresses encountered by the drug product.  In this presentation, the impact of silicone oil (from siliconized stopper) on product quality and effectiveness of surfactant as a formulation control on an IgG1 mAb was examined. The presentation will explain the impact of container closure components and the role of surfactant on stability of the molecule during transportation and storage. 

  • Suzanne Hudak, MedImmune

5 pm 5:15 pm (15 mins)

Closing Remarks

5:15 pm 6:45 pm (90 mins)

Networking Reception

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