Cambridge Healthtech Institute’s 5th Annual

Process Characterization and Control
( 製程的特性評估與控制 )

A Best Practices Forum for the Translation of Process Understanding into Control Strategies for Maintaining Quality Throughout the Product Lifecycle



With the recent publication of process validation guidances from both US and European regulators, the demonstration of process understanding, identification of critical quality attributes and the implementation of well-validated control strategies must now become a routine part of biologics manufacturing operations.  But significant ambiguities remain in the specific steps that must be taken in the production of legacy and new products, by companies of different scale and resources and for specific product formats. Process Characterization and Control offers a forum for the sharing of strategies and best practices from a wide range of industry companies working to implement these complex new standards.

Final Agenda


11:30 am Registration Open

12:15 pm Enjoy Lunch on Your Own

1:15 Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing (Sponsorship Opportunity Available)


1:55 Chairperson’s Remarks

George Bou-Assaf, PhD, Scientist, Biogen

2:00 KEYNOTE PRESENTATION: Process Control as an Enabling Technology for Continuous Vaccine Production

Braatz_RichardRichard D. Braatz, PhD, Professor, Chemical Engineering, Massachusetts Institute of Technology

Continuous manufacturing has the potential to significantly improve efficiency, boost production, and reduce the cost of vaccine manufacturing. The presence of defective interfering particles has been shown to result in large periodic variations in virus titers, limiting overall production rates. This talk describes the design of process control systems that simultaneously remove process oscillations and increase the overall production rate.

2:45 Medium Preparation Bench-Top Scale Down Model

Read_ErikErik Read, PhD, Senior Scientist, Manufacturing Sciences and Technology, AstraZeneca

During GMP manufacturing, issues arise that require investigation and experimentation, but are expensive at full-scale. We describe modification of a bench-top bioreactor as a scale down model for medium preparation. The model accelerates studies, while reducing cost and enhancing process understanding. The results of a qualification study will be presented.

3:15 Process Characterization Planning & Execution for an Effective Product Lifecycle Management

Pathak_NaveenNaveen Pathak, Director, Pharmaceutical Science, Takeda

Process Characterization is a time and resource-intensive activity to enable process understanding as described in ICH Q8. The presentation will discuss strategies and efficient execution of characterization studies related to determination of control strategy, successful completion of technology transfer, and lifecycle management. A system for knowledge management of the acquired process understanding over the product lifecycle will be highlighted.

3:45 Sponsored Presentation (Opportunity Available)

4:00 Refreshment Break

4:15 Process Characterization for Cell and Gene Therapies; Contrast with Protein Therapeutics

Bou_assaf_GeorgeGeorge Bou-Assaf, PhD, Scientist, Protein & Gene Therapy Biophysical Characterization, Biogen

Gene therapy products comprise a capsid of proteins and a nucleic acid packaged inside. Given the complex structural assembly, advanced analytical tools are indispensable for process characterization. We describe how several analytical tools traditionally employed for protein therapeutics can be applied as is or adapted to gene therapy products. In addition, we describe challenges uniquely associated with gene therapy products and how they were overcome with new methods and instrumentation.

4:45 Application of High Throughput Chromatography for mAb Downstream Process Characterization

Rowicki_PatriciaPatricia Rowicki, Biologics Process Research and Development, Merck Research Laboratories

High throughput process development (HTPD) approaches are becoming the preferred development approach over traditional lab scale column studies. Key advantages of HTPD include enhanced process understanding and decreases in time and material requirements. This approach has been utilized to effectively identify operating parameters that significantly impact product attributes and accelerate commercial process development and characterization. A case study describes the strategies, successes, and challenges of implementing these tools into process characterization.

5:15 End of Day


7:30 am Registration Open

7:30 Small-Group Breakout Discussions with Continental Breakfast

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges.


8:30 Chairperson’s Remarks

Marina Kirkitadze, PhD, Head, Analytical Process Support & PAT Platform, Analytical Sciences, Sanofi Pasteur, Canada

8:35 Phase Appropriate Approach to Analytical Comparability for Innovator Biotherapeutics: How Much is Enough?

Taktak_SoniaSonia Taktak, PhD, Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

As drug candidates move though development, manufacturing process improvements and formulation changes can impact product quality attributes. The goal of a comparability exercise is to ensure that these changes have no adverse impact on the quality, safety and efficacy of the drug. In this presentation, we will review key components of a successful analytical comparability strategy based on product-specific considerations, phase of development (early, late) and nature of the change(s).

9:05 Update on BioPhorum’s Roadmap for Inline Monitoring and Real-Time Release

Aich_UdayanathUdayanath Aich, PhD, Associate Director, Bristol-Myers Squibb

Real time monitoring and in-time release of product attributes create a demand to move testing of CPP and CQA from off-line analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring) for reducing speed, cost and maximizing quality of product. The presentation will focus on the advance in implementation of BioPhorum’s ILM-RTR roadmap strategy related to Business case development and URS completion for a prioritized list of desired CQA’s and CPP, due to be published as part of a White Paper in 2019.

9:35 Mass Spectrometry Analysis of Critical Reagents to Support ADC Development

Yao_ChunxiangChunxiang (Kady) Yao, PhD, Scientist, Mass Spectrometry, Analytical & Pharmaceutical Sciences, ImmunoGen, Inc.

Critical reagents are controlled chemicals and biological components or reference standards that may have substantial impact for certain analytical/bioanalytical procedures. During antibody-drug-conjugate (ADC) development, it is essential to provide systematic characterization of critical reagents to support analytical method development and pharmacology studies for various programs. Mass spectrometry-based methods have been used to provide rapid identification, purity and stability analysis, and structural characterization of critical reagents.

10:05 Networking Coffee Break

10:30 Development, Validation and Implementation of a SEUHPLC Method Based of USP <129>

Cheung_Wen-LiWen-Li Chung, Quality Control Scientist, Genentech

USP <129> was published in 2016 which provides detailed instructions regarding how to perform SEC with a generic USP reference solution as a system suitability method control. Size-exclusion ultra high-performance liquid chromatography, an alternative method was developed based on this USP <129> SEC method and then validated according USP <1225> with various molecular weight ranging from Fab to bispecifc proteins.  Results of the study demonstrated equivalency of these two methods.


11:00 Innovative AI Tools Applicable for Process Control and Automated Device Integration

Paul_WolfgangWolfgang Paul, PhD, Principal Scientist and Digitalization Lead, Large Molecule Research, Roche, Germany

Therapeutic proteins development becomes more challenging due to the complexity of the diverse molecule formats. Drug development and particular process development use more and more high throughput systems which require sampling for controlling and generate a huge amount of data. Therefore, we developed a new soft sensor, as non-invasive sensor application. The new approach, based on artificial neural network, processed the common online signals of the bioreactors to estimate the cell growth and key metabolites during cultivation time.

11:30 Cross-Functional Data Harmonization for Predictive Pharmaceutical Development

Wilbertz_AxelAxel Wilbertz, Data Scientist, AbbVie, Germany

Modern drug development is highly resource-intensive and new highly-engineered protein-based variants are entering the pharmaceutical development pipelines. AbbVie invested in miniaturized automated high-throughput screening. The aim is to collect standardized data sets to apply machine learning to support formulation design space. How can in silico methods guide liquid formulation development? Prior knowledge from multiple departments and homology models can provide predictive descriptors for protein stability.

12:00 pm Sponsored Presentation (Opportunity Available)

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break


1:25 Chairperson’s Remarks

Wei Xue, PhD, Senior Process Scientist, Regeneron Pharmaceuticals, Inc.

1:30 Inline Probes for Process Monitoring and Product Characterization

Kirkitadze_MarinaMarina Kirkitadze, PhD, MBA, Head, Analytical Process Support & PAT Platform, Analytical Sciences, Sanofi Pasteur, Canada

Interaction between antigen and adjuvant or adsorption of antigen to adjuvant is critical for the effective adsorption. Particle size distribution of aluminum phosphate and adsorbed protein were examined by Laser diffraction and Focused Beam Reflectance Measurement at line and inline respectively. Compositional analysis of aluminum phosphate was performed at line using FTIR and Raman spectroscopy, and inline ATR probe were used to examine adsorbed protein suspension.

2:00 Oxygen Uptake Rate (OUR) Measurement of Mammalian Cells with a Real-Time Off-Gas Analyzer

Xue_WeiWei Xue, PhD, Senior Process Scientist, Regeneron Pharmaceuticals, Inc.

Oxygen uptake rate (OUR) is one of the most important measurable indicators used to reveal cell status and intensity of cellular metabolic activities. At Regeneron, the Sartorius BioPat® Xgas off-gas analyzer was evaluated for its potential to measure on-line OUR with example small-scale processes. In the evaluation, it was clearly demonstrated that OUR shows strong correlation with cell growth and glucose consumption.

2:30 Development of High-Resolution Isoelectric Chromatofocusing for In-Process Monitoring of Monoclonal Antibody Charge Variants

Zhao_HelenHelen Zhao, Associate Scientist, Process Development Analytics, Bristol-Myers Squibb

The development of an at-line isoelectric chromatofocusing (ICF) method for the analysis of monoclonal antibody charge variants is presented here. This method shows comparability to conventional imaged capillary isoelectric focusing for protein charge analysis. This ICF technique implements a linear pH gradient on strong anion exchange media and was applied on an at-line UPLC system to monitor the charge variant profile of an ion exchange process eluent in real time.

3:00 Application of High Throughput and Rapid Technologies for Product Quality Assessment

Brousseau_AnnaAnna Brousseau, Senior Development Associate, High Throughput Sciences, Analytical & Pharmaceutical Sciences, Immunogen

To support timelines for Cell Line Development and Upstream Engineering, the High Throughput Sciences (HTS) team executes a two-week turnaround workflow for rapid Product Quality (PQ) assessment. In addition to Cell Line Development and Upstream support, HTS also partakes in process characterization by utilizing robotics for purification and sample handling. The strategies, technologies and PQ assays will be discussed in this presentation.

3:30 Close of Conference

* 活動內容有可能不事先告知作更動及調整。