2016 Archived Content
Protein Aggregation & Stability

With novel biomolecules comes higher burdens of aggregation, stability challenges and immunogenicity risks. As companies embark on the journey to develop new and novel molecules, they are realizing that these emerging molecules are highly heterogeneous, prone to aggregate, highly unstable and pose a substantial risk to immunogenicity and thus, regulatory challenges. The ability to detect, identify, quantify and characterize these aggregates and particles, visible or invisible, are thus of paramount importance. At the Protein Aggregates & Stability meeting, we invite scientists to discuss the mechanisms of aggregation, predict aggregation propensity, conduct stability studies, and compare tools for the characterization and quantification of these aggregates and particles.

WEDNESDAY, APRIL 6

1:00 pm Registration


JOINT PLENARY SESSION
THE PROMISE OF NOVEL CANCER BIOTHERAPEUTICS

2:00 Chairperson’s Opening Remarks

Daotian Fu, Ph.D., General Manager, Livzon MabPharm

2:05 Developing Antibody-Drug Conjugates for the Treatment of Solid Cancers

Parren PaulPaul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director, Genmab

Therapeutic antibodies have revolutionized the treatment of cancer. However, many patients still fail to respond or become resistant to targeted treatment and novel innovative approaches to improve therapy are therefore required. Chemical engineering of antibodies, fueled by recent molecular insights, is providing important opportunities for the development of more potent antibody therapeutics. The progress in two antibody-drug conjugate programs from Genmab’s portfolio will be highlighted.

2:35 Engineering the Next-Generation Antibody-Drug Conjugates for Cancer Therapy

Wu HerrenHerren Wu, Ph.D., CTO, MedImmune/AstraZeneca

Linking of highly potent cytotoxic warheads to tumor-targeting antibodies has the potential to attack tumors with missile-like precision and avoid toxicity to normal tissues. However, clinical observations indicate that the therapeutic window of most antibody-drug conjugates (ADCs) remains narrow. I will discuss our efforts in developing next-generation ADC technology which seeks to address the short-comings observed with current ADCs and help realize the full potential of this drug class to provide new breakthrough agents for the treatment of cancer.

3:05 Cancer Immunotherapy: Delivering the Promise

Weikang TaoWeikang Tao, Ph.D., Vice President & CEO, R&D Center, Jiangsu Henrui Medicine Co., Ltd.

Recent breakthroughs in treating different types of advanced-stage malignancies by harnessing self immunity against neoplastic cells showed a great promise of immunotherapy for cancer treatment. Various strategies have been employed to unleash, enhance or elicit anticancer immune reactions, which include T-cell checkpoint blockade, engineered T cells, BiTE, modified cytokines and cancer vaccines. This presentation will review recent progress in cancer immunotherapy and discuss some immunotherapeutic agents discovered and developed at HengRui Medicine Co., Ltd.

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing


CHALLENGES FOR NEW BIOLOGICS DEVELOPMENT IN CHINA

4:10 Update on Recent Regulatory Changes for Biologics Development in China

Fu DaotianDaotian Fu, Ph.D., General Manager, Livzon MabPharm

Over the past several years, the biotech industry in China has experienced tremendous growth, both in biosimilars and innovative biologics. In the meantime, the CFDA is also going through significant reforms with respect to guidance and the reviewing process for development of both biosimilars as well as innovative biologics. In this presentation, the author intends to provide an update on the recent development in CFDA’s guidance for biologics development in China, and how the biotech industry can best position itself to take advantage of the recent regulatory changes.

4:40 PANEL DISCUSSION: Understanding the Clinical and Regulatory Pathways for New Biologics Development in China

Moderator: James Cai, Ph.D., Vice President, Global Regulatory Affairs, Access & Policy, Amgen Shanghai

Panelists:
Daotian Fu, Ph.D., General Manager, Livzon MabPharm
Weidong Jiang, Ph.D., CSO, Shanghai Henlius
Weikang Tao, Ph.D., Vice President & CEO, R&D Center, Jiangsu Henrui Medicine Co., Ltd.
Scott M. Wheelwright, Ph.D., CEO, Complya Asia


5:40 Close of Day


THURSDAY, APRIL 7

8:30 am Morning Coffee

8:50 Chairperson’s Opening Remarks

Danny K. Chou, Pharm.D., Ph.D., President, Compassion Biosolution


NEW FRONTIERS IN UNDERSTANDING PROTEIN AGGREGATION BEHAVIOR AND MECHANISMS OF ACTION


»9:00 KEYNOTE PRESENTATION: DESIGNING PROTEIN SOLUBILITY

Ventura SalvadorSalvador Ventura, Ph.D., Professor, Biochemistry and Molecular Biology, Institute of Biotechnology and Biomedicine, University of Barcelona

One of the major challenges that one should face during the development of protein-based biopharmaceuticals is their inherent propensity to aggregate. Indeed, protein therapeutic agents are both stored and typically administered at very high concentrations. Under these conditions they can easily aggregate, impacting the product’s developability, stability, formulation, and immunogenicity. I will discuss how computationally-assisted design of protein structures solubility is helping us to overcome these limitations.


9:30 Using in silico Tools to Predict the Propensities for Aggregation and for Viscosity

Bernhard Helk, Ph.D., Distinguished Fellow, Biologics Technical Development and Manufacturing, Novartis Pharma AG

Three in silico tools and their practical application to the prediction and characterization of protein-protein-interaction are demonstrated: SAP (Spatial Aggregation Propensity) identifies hydrophobic patches and is applied to engineer mAbs and ADCs with increased stability. DI (Developability Index) predicts aggregation propensities based on SAP and net charge. SCM (Spatial Charge Map) ranks mAbs according to viscosity. Case studies for predicting crystallization and viscosity of mAbs are presented.

Protein Simple10:00 Automating Protein and Particle Characterization in Biopharmaceuticals

Yingying Du, Field Applications Scientist, ProteinSimple

Charge variant analysis and sub-visible particle analysis are key product attributes. Automated methods for charge heterogeneity detection such as imaged capillary isoelectric focusing (icIEF) and particle monitoring such as micro-flow imaging (MFI) have been widely adopted by the biopharma industry. icIEF provides rapid high resolution charge variant separation with easy method development and minimal start up time. Meanwhile, MFI provides particle morphology in addition to particle size and count. We will provide an overview of iCE and MFI technologies and their applications in biopharmaceuticals.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Understanding Protein Aggregation – Opalescence, Turbidity and Particulates

Wei_WangWei Wang, Ph.D., Senior Scientist, Global Biological Development, Bayer Healthcare

The large number of biological candidates in the pipeline demands an efficient product development process. However, many of these candidates are prone to aggregation. Depending on the aggregation pathways/mechanisms and/or extent, an aged solution of a biological product can possess different appearances - opalescence, turbidity, and/or presence of particles. This presentation discusses the similarities and differences of these appearances and the associated possible aggregation pathways/mechanisms.

11:30 Roles of Solution Composition on Protein Thermal Unfolding and Aggregation Kinetics

Jifeng Zhang, Ph.D., Head, Drug Delivery and Device Development, MedImmune

Maintaining biophysical stability is an essential aspect in developing liquid formulation of therapeutic monoclonal antibody drug product. Solution conditions, e.g. pH, salt ion type and concentration, play important roles of determining antibody thermal stability and aggregation kinetics. In this presentation, the mechanistic pictures of protein-ion interactions and protein-protein interactions will be delineated to highlight their implications on thermal stability and aggregation kinetics.

12:00 pm Selected Poster Presentation:

Cell and Process Engineering Strategies to Cure Aggregation of a Difficult-to-Express Fusion Protein in CHO Cells

Yusuf Johari, Ph.D., Post-Doctoral Research Associate, Chemical and Biological Engineering, The University of Sheffield

Based on a diagnostic transient production assay to identify limitations in the ability of CHO cells to produce a model "difficult-to-express" Fc-fusion protein, we compared different strategies (cell engineering, addition of chemical chaperones, hypothermic condition) to alleviate cellular aggregation and the associated poor expression. Our analysis serves as a paradigm for multivariate optimization of DTE protein production.

12:30 Networking Luncheon in the Exhibit Hall with Poster Viewing

1:45 Chairperson’s Remarks

Jifeng Zhang, Ph.D., Head, Drug Delivery and Device Development, MedImmune


AGGREGATION DURING PROCESSING AND FORMULATION

1:50 Investigating Mechanisms of Monoclonal Antibodies Particle Formation during Drug Product (DP) Processing

Yuh-Fun_MaaYuh-Fun Maa, Ph.D., Principal Engineer, Genentech, Inc.

Monoclonal antibody (mAb) particle formation observed during bottom mounted mixing and filling by piston pump was investigated to understand the root-cause mechanisms leading to protein degradation. The design of the mixer and the pump plays a critical role and any designs with contacting moving parts may grind the mAb molecules to immediately form particles. The impact of grinding on protein particle formation was assessed based on shear, local heat and cavitation.

2:20 Aggregation of Proteins during Bioprocessing: Mechanisms and Management Strategies

Danny K. Chou, Pharm.D., Ph.D., President, Compassion Biosolution

Protein aggregation is not only a challenge in the development of drug products, it is a significant barrier to cost-effective production of purified bulk drug substance. The goal of this presentation is to give some examples of how protein aggregation affects bioprocessing (e.g., purification including viral filtration), potential mechanisms, and how one may overcome this challenge.

2:50 Detectability of Endotoxin Contaminations in Biologicals

Johannes_ReichJohannes Reich, MSc, Ph.D. Student, Physical Chemistry, Universität Regensburg /Hyglos GmbH

In recent presentations and publications, the issue of Low Endotoxin Recovery (Endotoxin Masking) has been discussed. Thereby, formulated drug products often contain surfactants and buffer components in order to stabilize the active pharmaceutical ingredients (API). Interestingly, such components can affect the detectability of potential Endotoxin contaminations in common detection systems. Here, we show examples of masked Endotoxin in common product matrices and the applicability of dedicated demasking procedures.

3:20 Surfactants in Biotherapeutics: Impact, Analysis and Control

Satish D. Singh, Ph.D., Research Fellow, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.

Non-ionic surfactants in therapeutic protein formulations, added in small amounts, generally protect the protein from physical degradation at interfaces. The most popular surfactants are the polysorbates. The polysorbates can degrade by various mechanisms and the degradation products can also impact the stability of the protein. The importance of this excipient has led to a resurgence of interest in all questions related to their use in biotherapeutics, including analysis and control.

3:50 Stability and Formulation Challenges for Biological Drug Products

Jun_XiangJun Xiang, Ph.D., Vice President, Pharmaceutical Science & Technology, Biotechnology Institute of Shanghai CP Guojian Pharmaceutical Co., Ltd.

Proteins and antibodies are “fragile” during processes, handling, storage, etc. A good formulation is critical for the stability of biological drug product to prevent any foreseeable or unforeseeable degradation. This presentation provides an overview of the possible challenges in the formulation development for biological drug products and will share some thoughts with case studies on overcoming these challenges to achieve a successful commercial launch of drug product.

4:20 Close of Conference

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Celebrating 25 Years


Track 1

Protein & Antibody Engineering

Track 2

Protein Aggregation & Stability

Track 3

Immuno-Oncology

Track 4

Analytical Characterization of Biotherapeutics