From method development to qualification to validation and transfer, it is a continuous yet inter-dependent process from early research to development to QC and release. Depending on which stage of product development you are in, your method may or may not need to be robust, qualified or validated. The objective is to prove that methods selected are fit for their intended purpose.

With an expanded portfolio of newer formats and non-mAbs in the pipelines, knowledge, experience and advanced techniques are critical to establish efficient, accurate and fit-for-purpose analytical methods that can be later qualified, validated and transferred to release testing, thereby improving efficiency and reducing cost, time and resources.

Final Agenda

MONDAY, MARCH 12, 2018

7:30 am Registration & Morning Coffee

8:30 Chairperson’s Opening Remarks

Mark T. Fisher, PhD, Professor, Biochemistry and Molecular Biology, University of Kansas Medical Center


8:40 Regulatory Address: Regulatory Perspectives on Analytical Method Validation and Transfer for Biopharmaceutical Products

Ramesh Potla, PhD, Product Quality Team Leader, CDER, FDA

A risk-based approach should be used to determine the totality of evidence needed to demonstrate a successful method transfer. This presentation will focus on our current expectations about the validation and any subsequent site transfer of validated analytical methods for biotechnology products. Case studies will be presented with the goal of sharing lessons learned during the regulatory review of non-compendial analytical method validation and transfer for licensed therapeutic proteins.

9:20 MAM Method Development and Qualification

Richard Rogers, PhD, Scientist 4, Just Biotherapeutics

We have developed and implemented a mass spectrometry based multi-attribute method (MAM) that monitors known CQAs but also can identify new CQAs on the biotherapeutics. This method has been successfully used in the process development lab. Our goal is to leverage the MAM for release of biotherapeutics from the quality lab. Method qualification and specification limits for the MAM will be discussed in this presentation.

9:50 The Next Frontier in Subvisible Particle Analysis: New Tools and Potential Opportunities

Danny K. Chou, PharmD, PhD, President, Compassion Biosolution, LLC

In the past decade, we have witnessed the arrival of a large number of analytical technologies that are useful for characterizing sub-visible particles in protein therapeutics. Even with the diverse tools that are available today, there are still important gaps that have not been filled but yet have a significant role in our ability to fully analyze particles for either product characterization or development purpose. The goal of this presentation is to highlight some of these gaps and share the potential opportunities that may be captured by new tools that are on the horizon.

10:20 Networking Coffee Break


10:45 Chairperson’s Opening Remarks

Kevin Zen, PhD, Senior Director, Analytical and Formulation Development, AnaptysBio



10:50 Analytical Method Replacement Strategies and Case Studies for Late-Stage Development and Approved Products

Stephan O. Krause, PhD, Director, QA Technology, Clinical/Commercial Biologics Operations, AstraZeneca

11:20 Developing and Qualifying a Flow Cytometry Assay for Release Testing

Sindhuja_RaoSindhuja Rao, PhD, Senior Scientist, Biotherapeutics & Pharmaceutical Sciences, Analytical R&D, Pfizer, Inc.

A cellular drug product requires accurate quantification of the level of expression of pertinent cell surface proteins on a per-cell basis. This can be accomplished by flow cytometry, but qualifying a cytometry-based release test is challenging due to the inherent variability of acquisition and the subjective analysis of the data, as well as software and hardware capabilities. Working through these components led to key learnings for future cellular identity assays.

11:50 Development and Implementation of High-Throughput Assays to Support Process Development

Greg_CantinGreg Cantin, PhD, Scientist III, Manufacturing Sciences, Five Prime Therapeutics, Inc.

The development and implementation of high(er)-throughput methods to support process development will be discussed. The two main goals for these activities are: 1) increasing the speed of sample throughput, and 2) achieving acceptable method performance. Examples of activities that resulted in significant increases in sample throughput will be presented. Additionally, method performance outcomes will be presented for multiple higher-throughput methods that have been implemented.

12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:50 Session Break

1:40 Chairperson’s Remarks

Greg Cantin, PhD, Scientist III, Manufacturing Sciences, Five Prime Therapeutics, Inc.


1:45 Qualification of a New Platform Method for Concentration and DAR Determination of Antibody-Drug Conjugates (ADCs)

Michael FlemingMichael Fleming, PhD, Asso Director, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

2:15 Analytical Strategies for the Regulatory Filing of Early Phase Biotherapeutics

Kevin Zen, PhD, Senior Director, Analytical and Formulation Development, AnaptysBio Inc.

2:45 Networking Refreshment Break

3:15 Method Development and Qualification of Next-Generation Antibody-Based Therapeutics

Jared_BeeJared Bee, PhD, Senior Scientist, Analytical Sciences, Macrogenics, Inc.

DART(R) molecules are bispecific antibody-based proteins developed for a variety of indications including immuno-oncology, and are designed to simultaneously bind to two targets. These versatile molecules have the potential for improved efficacy and safety profile through enhanced selectivity and recruitment of specialized effector cells. This presentation will discuss method development and qualification approaches using this novel class of molecules and other antibody molecules as case studies. 

3:45 Platform Approach for Method Development and Qualification for Early-Phase Programs

Matthew_ValcorbaMatt Valcorba, Principal Research Associate, Bioanalytics, Sanofi

4:15 Roundtable Breakout Session

How Do You Determine the Appropriate Levels of Process-Related Impurities for Early Development Stages (Non-Pivotal, Phase I-II Studies)?

Moderator: Greg Cantin, PhD, Scientist III, Manufacturing Sciences, Five Prime Therapeutics

  • Information used in setting appropriate levels (acceptance criteria) for contaminants
  • Are statistical methods needed to set expected range or acceptance criteria in Phase I-II?
  • When is testing not needed for release?
  • Overall risk assessment for the decision process

Application of Design of Experiment (DOE) in Analytical Method Development

Moderator: Dengyun “Daisy” Sun, PhD, Senior Scientist, Biologics Analytical Sciences, Merck & Co.

  • Design of Experiment (DOE) versus One Factor at a Time (OFAT)
  • How to interpret DOE result
  • Challenges in DOE and how to overcome (case studies)
  • Regulatory expectation

5:15 Close of Day/Short Course Registration

6:00 Dinner Short Courses*

SC1: Particles in Biotherapeutics: Characterization & Impact

SC2: The Multi-Attribute Method (MAM) for Improving Product and Process Development

*Separate registration applies.


8:00 am Morning Coffee

8:30 Chairperson’s Opening Remarks

Danny K. Chou, PharmD, PhD, President, Compassion Biosolution, LLC


8:40 Development and Qualification of an Activity Assay Using a Physiologically Relevant Substrate

Kannappan Veeraragavan, PhD, Head, Method Development Separation Science, Analytical Development, Shire

Mucopolysaccharidosis II (Hunter syndrome) is an X-linked lysosomal storage disease cause by lack of a specific enzyme called iduronate-2-sulfatase (I2S). The in vitro activity of I2S is measured by using a physiologically relevant substrate (PRS). An assay was developed and qualified to measure the specific activity of I2S which is being manufactured by recombinant technology.

9:10 Development and Qualification of a Novel Cell-Based Assay for Therapeutic mAb against Viral Infection

Dengyun_Daisy_SunDengyun Sun, PhD, Senior Scientist, Biologics Analytical Sciences, Merck & Co.

We have explored several cell-based assay platforms in support of therapeutic mAb development against viral infection. The advantages and disadvantages of the methods were compared to meet different project needs. In this study, we chose a luciferase based method and further optimized the assay using Design of Experiment (DOE). The new assay is under qualification in terms of accuracy, linearity, intermediate precision, specification and robustness.

9:40 Developing Cell-Based Functional Assays to Modulate Nature Killer Cells (NK cells) for Cancer Immunotherapy

Zhengmao_YeZhengmao Ye, PhD, Scientist, Biochemical and Cellular Pharmacology, Genentech, Inc.

In searching for novel biotherapeutics for cancer immunotherapy, we targeted a soluble protein that regulates human NK cell function. In this talk, I will present several novel cell-based functional assays for screening and advancing the lead candidates.

PerkinElmer NEW 200910:10 PerkinElmer Solutions to Facilitate the Development, Qualification & Validation of Protein-Based Biotherapeutics

Roger Bosse, Sales Development Team Lead, PerkinElmer

We will present relevant solutions applicable to the different stages of Biotherapeutics drug development ranging from pre-clinical to commercial manufacturing. Representative applications and related customer cases will be reviewed, namely: (1) homogenous assays for measuring protein-protein interactions including FcyRXA binding, detection of biomarkers and host cell contaminants; (2) bioassays to probe intracellular signaling pathways and cytotoxicity for potency/mechanism of action and (3) microfluidics-based critical quality characterization of Biotherapeutics.

10:40 Opening Coffee Break in the Exhibit Hall with Poster Viewing

11:20 How to Utilize Design of Experiment (DoE) Principles for Developing Robust Analytical Methods for QC Environments

Jeremy_SpringallJeremy Springall, PhD, Scientist I, Analytical Sciences, MedImmune

Developing robust analytical methods that will be routinely used in QC environments can prove to be very challenging when using a one factor at a time approach. In this presentation, I will communicate how we can use DoE approaches and a large design space to develop analytical methods and assess their robustness.


11:50 Selected Poster Presentation: Assay-Ready Cells: The Future of Bioassays

 Saira Ahmed, MSc, Scientist II, Analytical Development & Quality Control, AbbVie   

12:10 pm Close of Method Development, Qualification & Validation