Cambridge Healthtech Institute’s 5th Annual Analytical Forum

Accelerating Analytical Development

Optimizing the Speed and Efficiency of Key Analytical Steps in Biotherapeutic Development

August 15-16, 2018


Research for this meeting revealed that industry analytical groups are facing increased pressure to deliver key analytical studies used in candidate selection, process development, clinical development and regulatory submissions faster than ever before – and at lower costs. Accelerating Analytical Development offers a best practices forum in which industry scientists and managers can exchange ideas on strategies, new technologies and the integration of analytical methods in support of these goals. The conference will address the most important roles of the analytical function at every stage of development and provide insights on how different organizations are addressing these challenges.


Final Agenda

Wednesday, August 15

7:00 am Registration Open and Morning Coffee (Grand Ballroom Foyer)

OPTIMIZING THE SPEED AND EFFICIENCY OF ANALYTICAL DEVELOPMENT
Back Bay B

8:05 Chairperson’s Remarks

Christina Vessely, PhD, Senior Consultant, Analytical and Formulation Development, Biologics Consulting


8:15 KEYNOTE PRESENTATION: Balancing Speed and Resource Considerations in the Selection of Fit-for-Purpose Assays at Each Stage of Development

Jennifer_NemethJennifer F. Nemeth, PhD, SCPM, Director, Biophysics, Structural Characterization, Biologics Discovery Sciences, Janssen Research & Development

The need for fit-for-purpose biophysical assays at each stage of development is well established. Early discovery requires fast assessments using limited material. In contrast, later development studies are routine, validated, and robust with minimal material constraints. Depending on the function, studies operate in a regulated environment requiring GLP or GMP conditions. Here, the assay path for large molecule analyses are examined, with an emphasis on scale, desired information, and impact to development.

9:00 Best Practices for Comparability Analysis Following Method Changes and Method Bridging

Chris_VesselyChristina Vessely, PhD, Senior Consultant, Analytical and Formulation Development, Biologics Consulting

Analytical methods and specifications evolve across the product development lifecycle, including the addition of new analytical methods or improvements to current methods. As the need arises for process changes to support ongoing clinical studies, it is necessary to demonstrate that materials produced from the post-change process are comparable to those produced in the pre-change process. This presentation discusses strategies for bridging across method changes to establish product comparability.

9:30 Feasibility and Challenges in Machine Learning Approaches to Predicting Biophysical Properties from Sequence and Structure

Tileli_AmimeurTileli Amimeur, Data Scientist, Molecular Design, Just Biotherapeutics

Biotherapeutic development is a slow and costly process. We can make use of data to improve screening, engineering, and optimization of molecules for downstream properties. Predictive methods can reduce the time and cost of development while delivering higher quality biologics. We explore the feasibility and challenges in building machine learning models for predicting biophysical properties of therapeutic antibodies from sequence and structure.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)

10:45 Regulatory Considerations in Determining Analytical Strategy for Phase I Programs

Vaneet_SharmaVaneet K. Sharma, PhD, Manager, Analytical Development, Vaccine Development & Manufacturing, International AIDS Vaccine Initiative (IAVI)

This presentation will outline key regulatory considerations in determining analytical strategy especially for exploratory and Phase I programs. Analytical strategies for the assay development, assay qualification and characterizing the critical quality attributes (CQAs) relevant to Phase I/II clinical trial material will be discussed. A case study will be presented to demonstrate the application of the regulatory accepted phase-appropriate analytical characterization to support HIV vaccine development.

11:15 An Efficient Analytical Development Strategy Enabling Expedited Development of Therapeutic Products

Xiaoyang_ZhengXiaoyang Zheng, PhD, Principal Scientist, Biopharmaceutics Development, Sanofi US

An efficient approach for a new analytical method development consists of five stages with clear deliverables: method definition, platform selection, development and optimization, evaluation, and documentations. We will present case studies to show how to streamline method development using previous knowledge, job aids, platform, and templates to define performance requirements, identify key variables, increase method robustness, design-appropriate control strategy, and reduce development time/costs.

11:45 pm Enjoy Lunch on Your Own

1:00 Session Break 

EMERGING METHODS AND INSTRUMENTS TO SUPPORT ACCELERATED DEVELOPMENT
Back Bay B

1:45 Chairperson’s Remarks

Lintao Wang, PhD, Principal Scientist and Mass Spec Group Leader, Analytical and Pharmaceutical Science, ImmunoGen, Inc.

1:50 Capillary Electrophoresis Sodium Hexadecyl Sulfate (CE-SHS): A Novel Approach to Characterizing the Purity of a Therapeutic Protein

Jeff_BeckmanJeff Beckman, PhD, Senior Scientist, Bristol-Myers Squibb

Accelerated commercial process development is the new norm in pursuit of meeting patient requirements, and analytical data integrity is key to making speed to market possible. We present data from a newly developed high-resolution CE-SHS technology that markedly improved data integrity relative to standard approaches (e.g. CE-SDS). This CE-SHS-based technique has become integral at BMS for relevant accelerated assets.


2:20 Novel IR Microfluidic Device for Secondary Structure Assessment of an Antibody and its ADC

Karan_ShahKaran Shah, Principal Development Associate, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

Protein secondary structure is an important aspect of higher order structure characterization of biotherapeutics and can provide vital information about stability, aggregation, comparability etc. It becomes even more critical in ADCs since folding patterns of parent antibody may be altered due to conjugation with hydrophobic payload which may affect biological properties. This talk will cover analysis of antibodies and corresponding ADCs using a new Microfluidic Modulation Spectrometry (MMS) technique and compare the results with conventional approaches.

2:50 Online Peptide Immuno-Affinity Enrichment (PIE) LC-MS Application in Biodistribution Studies of Protein Therapeutics

Jessy_FanJessy Fan, PhD, Scientist, Amgen

For protein therapeutics, quantitative analysis of tissue distribution facilitates the understanding of in vivo exposure to response relationship. Online Peptide Immuno-Affinity Enrichment (PIE) LC-MS workflow has been developed to complement currently available technologies for biodistribution of protein therapeutics. The unique PIE feature of multiplexing capabilities and translatability from preclinical to clinical studies will be presented here, providing additional evaluation parameters of selecting protein therapeutics and their development.

3:20 New Developments in Reducing Sample Size Requirements for Common Assays

Jashua_LaberJoshua Laber, PhD, Postdoctoral Fellow, AbbVie

Current techniques are unsuitable for high-concentration viscosity measurements in early stage candidate molecule screening due to sample limitations. Here we introduce the iBEACON (integrated Buffer Exchange And CONcentration) which scales traditional tangential flow filtration (TFF) to <2 microliter final volume with 200-fold protein concentrations and provides continuous viscosity, shear, and filtrate flux rate measurements. This fully automated system also performs unattended in situ buffer exchanges for formulation screening of multiple samples.

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)


4:45 Plenary Keynote Session (Constitution Ballroom)

The Next 10 Years: Looking Ahead to Next-Gen Bioprocessing

4:45 pm Chairperson’s Remarks

John Sterling, Editor in Chief, Genetic Engineering & Biotechnology News (GEN)

 

Murray_Jerry4:50 Digital Transformation to Advance Next-Generation Biomanufacturing through Data Integration and Analytics

Jerry Murry, PhD, Senior Vice President, Process Development, Amgen

Hundreds of millions of data points are currently generated through the development and execution of biopharmaceutical processes. It is expected that the volume and complexity of biomanufacturing data is set to grow exponentially as developers and manufacturers integrate novel sensors, smart materials, process analytical technologies and process automation into laboratories and manufacturing plants. This presentation will describe the value associated with a comprehensive digital strategy incorporating a structured data integration and analytics platform inclusive of AI, predictive modeling and visualization, and how digital transformation can advance next-generation biomanufacturing.

5:20 Driving Change in Biomanufacturing through Innovation in Processes, Technologies and Operations

Eliana Clark, PhD, Vice President, International Manufacturing Operations, Biogen

A critical step in meeting the demand of biologic production worldwide involves implementing disruptive manufacturing technologies, processes and capabilities. This talk will use Biogen’s new manufacturing site in Switzerland, due to go online in 2019, as an example to demonstrate the new processes, operational models and technologies being adopted to drive value through innovation and deliver new medicines in areas such as Alzheimer’s.

5:50 End-to-End Solutions Considering New Trends in Biomanufacturing

Guillaume Plane, MSc, MBA, Manager, Global Development, Biodevelopment Solutions, MilliporeSigma

The presentation will get into the current state of biomanufacturing, from DNA to market approval, considering the way a key supplier can support drug makers to the fullest, thanks to a deep understanding of the trends that could affect our industry in the midterm, including growth of the pipelines, strengthening of regulations, and acceleration of timelines, for development as well as for the set-up of capabilities. Some thoughts and ideas will be proposed to consider commercial manufacturing with single-use equipment.

6:25 Close of Plenary Keynote Session

6:25 10th Anniversary Champagne Celebration in the Exhibit Hall with Poster Viewing (Grand Ballroom)

7:30 End of Day

Thursday, August 16

8:00 am Registration Open and Morning Coffee

SOFTWARE, DATA MANAGEMENT AND AUTOMATION CHALLENGES
Back Bay B

8:25 Chairperson’s Remarks

Alejandro Carpy, PhD, Laboratory Head Biochemistry, Roche Innovation Center Munich, Germany

8:30 Electronic Lab Environment: Software and Data Challenges

Richa_SarinRicha Sarin, Scientist, Technical Development, Biogen

Electronic lab environments can entail a multitude of heterogeneous systems to accommodate diverse scientific applications, resulting in significant challenges in interoperability. Two of those challenges include easily extracting knowledge and value from the data and limited exchange and visibility into the data. This presentation will focus on use cases aimed at addressing such challenges within an analytical development laboratory; automating delivery of data from our external partners and utilizing data analytics to enable swift and informed decisions.

9:00 Accelerating Insights through Aggregation of Formulation Data and Metadata from an Integrated Process Development Electronic Database

Shabnam_MolloyShabnam Molloy, Senior Associate Scientist, Amgen

The rise of electronic laboratory notebook and cloud data storage systems have enabled companies to structure the way data are collected to facilitate searching using key parameters. Visualization software tools can be configured to integrate cloud-based searches to make data collection and analysis easier for the average scientist without the need for additional manipulation. In this case study, we present an example of how this can be achieved to make faster, informed program decisions.

9:30 The Use of an Automation Platform to Reduce Assay Transfer Burden and Timeline - An Impurity Assay Development Study

Grimm WilliamWilliam Grimm, Scientist, Process Development Analytics, Bristol-Myers Squibb

The process of analytical transfer from Development labs and QC labs to multiple testing sites is a critical activity during all phases of drug development and commercial assets. Automation plays a major role in simplifying and expediting many plate based assays during Development. This work shows how an ELISA based assay with an automated liquid handler can be optimized to align with the manual best practice of a QC lab.


10:00 Coffee Break in the Exhibit Hall with 2nd Session Poster Winner Announced (Grand Ballroom)

ANALYTICAL DEVELOPMENT CHALLENGES OF NEW MODALITIES
Back Bay B

10:45 Correlation of Analytical Methods for Next-Generation Biologics from Molecular Assessment to Clinical Development

Alejandro_CarpyAlejandro Carpy, PhD, Laboratory Head Biochemistry, Roche Innovation Center Munich, Germany

In order to accelerate and optimize method development, we performed an in-depth assessment of the analytical data generated from lead candidate selection to technical development using customize methods and a combination of platforms developed for complex formats. Furthermore, we analyzed data collected for different molecular formats to ensure correct product quality and pCQA assessment across platforms during the analytical method development.

11:15 Analytical Development and Challenges for Bispecific Antibodies

Xiaoyu_YangXiaoyu Yang, PhD, Principal Scientist, Merck

Biologic drugs have evolved into an ever-growing diversity of modalities, such as monoclonal antibodies, bispecific antibodies, and peptides/proteins. Bispecific antibodies have received wide attention as a promising immunotherapeutic agent. Analysis of bispecific antibodies presents challenges because multiple antibody forms are potentially generated in cell culture. The analytical strategy and some example methods implemented to screen cell culture clones, monitor purification steps, and evaluate antibody purity will be presented.

11:45 Analytical Platforms in an Era of Novelty and New Modalities

Daniel McDonald, PhD, Researcher, Genentech

The increasing complexity of therapeutic protein modalities, combined with shrinking development timelines has put a strain on the platform method concept. This presentation discusses a nimble approach of coupling automated development software with a malleable platform method. With this approach, previously validated parameters can be optimized to create a product specific method. Ultimately, this will allow analytical platforms and their benefits (time, resource reduction) to be used for diverse modalities

12:15 pm Enjoy Lunch on Your Own

1:15 10th Anniversary Cake Break in the Exhibit Hall with Last Chance for Poster Viewing (Grand Ballroom)

1:55 End of Conference


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