Comparability at all Stages of Development

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WEDNESDAY, April 14

1:00 Registration & Coffee

2:00 Chairperson’s Remarks

Alain Bernard, Ph.D., Vice President, Global Process Development and Industrialisation, UCB Group 

COMPARABILITY TO SUPPORT PROCESS CHANGE

Featured Presentation

2:05 How Major Process Changes Can be Implemented to Improve Product Quality

Alain Bernard, Ph.D., Vice-President, Global Process Development and Industrialisation, UCB-Group

Using a couple of examples of recombinant therapeutic proteins, we describe strategies that enabled us to implement major process changes either during clinical development phases or after initial launch on the market with the key objective of product quality improvement. We will illustrate how, in most cases, major changes can be appropriately and safely implemented and achieve the expected deliverable of an improved quality, and how this significantly contributes to process and product understanding with positive impacts for the patients. We will exemplify how an extensive array of analytical tools, including some low-throughput but highly indicative quality tests can be used to support a demonstration of clinical comparability when it is necessary.

2:35  Fc Functionality Assessment in Support of Comparability Studies during Process Development

Yucai Peng, Ph.D., Scientist II, Analytical Development, Biogen Idec, Inc.

Fc functionality represents a significant part of quality attributes of antibody drugs. We have developed several bioassays for assessment of Fc functionalities in support of process development or comparability studies. Among the assays developed, an FcγRIIIa binding assay based on Alpha technology was used widely for analysis of post-translational modification, drug substance stability, and mechanism of action. Applications of the FcγRIIIa binding assay as well as other bioassays in characterization of Fc functionality will be discussed.

Featured Presentation

3:05 Comparability of an Antibody during Late-Phase Clinical Development with Multiple Changes

Margit Jeschke, Ph.D., Head, Analytical Research & Development, Novartis Biologics / Process Sciences & Production, Novartis Pharma AG

Several changes were introduced in the manufacturing process of an mAb1 after Phase I: the Sp2/0 based expression system was replaced by a CHO cell line and the production site and scale were changed. Additional process changes were implemented with the transfer to the commercial production site associated with a further scale-up. The comparability studies associated with these changes required extensive biochemical and physicochemical characterization and stability studies, and also biological characterization and pre-clinical and comparative pharmacokinetics studies. The results of the in-depth analytical characterization are presented and implications and conclusions of the comparability exercises will be discussed.

3:35 Networking Refreshment Break, Poster and Exhibit Viewing

TECHNOLOGY TRANSFER

4:10 Development of Reliable and Robust Transferable Analytical Methods

Marco Riedel, Ph.D., Director, Quality Assurance, ProBioGen AG

Method transfer is a proof of quality and one of the biggest challenges for demonstrating reliability and feasibility. It should be considered early in method development. The human factor plays an important role. A clear definition of responsibility and reasonable timelines enable efficient method transfer. As soon as possible those involved should discuss problems in reproducibility and other validation parameters. This discussion will become the basis for relevant training and for the definition of acceptance criteria for the transfer. Method transfer is not a product: it is a process and needs a service oriented understanding of all parties.

BIOPHYSICAL ANALYSIS FOR
COMPARABILITY STUDIES

4:40 Critical Biophysical Characterization for Establishing the Comparability of Biotherapeutic Compounds: a Comparative Study

Qin (Chin) Zou, Ph.D., Senior Principal Scientist, Bioprocess Analytic Department, Pfizer, Inc.

Drug manufacturers must demonstrate comparability of their products after process and formulation changes in order to ensure a product of similar quality, safety and efficacy. A critical quality test is biophysical analysis, where a variety of tools such as circular dichroism (CD) and fluorescence spectroscopy may be applied to monitor higher order structures that could potentially affect the drug potency. Distribution of size can also be evaluated by methods such as analytical ultracentrifugation (AUC) and dynamic light scattering (DLS). These are shown to complement traditional size exclusion chromatography (SEC) methods. Case studies on comparability using these techniques for different types of biologics are provided.

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 5:10 Scale Down Analytics for Early Stage Screening and Design Space Determination – “Manufacturability by Design”

James Wilson, Ph.D.,Director Sales and Marketing, Avacta

Scale down analytical techniques open up the possibility to thoroughly characterise candidate molecules at an early stage. The information gained can be used to help select candidates which are compatible with a wide range process conditions, help in rational design of optimised processes and help understand the potential effects of process changes before they are made.

6:30 Networking Reception in the Exhibit Hall

7:30 End of Day One