Cambridge Healthtech Institute’s Inaugural
Analytical Characterisation
Implementing New Technologies and Enhancing Analytical Strategies
New Dates - 21-22 JULY 2020
Bioprocessing Summit Europe is excited to announce the launch of a new conference stream dedicated to the Analytical Characterisation of Biotherapeutics. We bring together leading scientists from the biopharmaceutical industry, academia and government
to discuss novel characterisation methods, tools and technologies. Join us in Barcelona to improve your analytical strategies across all phases of development and production.
Final Agenda
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Tuesday, 21 July
8:55 Welcome Introduction
9:00 Chairperson’s Opening Remarks
Alistair Kippen, PhD, Vice President, BioPharmaceutical Development (R&D), Ipsen
9:05 KEYNOTE PRESENTATION: From Product Characterisation to Clinical Reliable Specifications
Gerald Gellermann, PhD, Senior Fellow, Analytical Development, Novartis
In this presentation we compare traditional assessment with an advanced and risk-based approach for definition and justification of specifications. The putative impact(s) on manufacturing process and lifecycle management are discussed. While the traditional
approach focusses on consistency, the advanced approach provides opportunities to utilize present understanding of structural-function relationships for the analyte molecule. This enables definition of limits which may extend outside those determined
by clinical experience. Where indicated, this is required to incorporate more worst-case assessments as the basis to predict future manufacturing variability. These scenarios are the basis for designing a robust commercial manufacturing process and,
further, facilitate an efficient product life-cycle management.
9:25 From Sample to Project Decision: Fully Automating MS Analytics of Next-Generation Protein Therapeutics
Miroslav Nikolov, PhD, Senior Scientist & Lab Head, Roche Pharma Research and Early Development (pRED)
I will present an end-to-end analytics workflow developed at Large Molecule Research (LMR) at Roche Innovation Center Munich. It allows full automation of sample registration, wet lab processing and MS measurement, as well as data management, analysis
and reporting applied on heterogeneous antibody-based drug candidate samples. Data and metadata are ultimately consolidated and stored in a way that enables mining and efficient and informed decision-making.
9:45 Presentation to be Announced
10:05 Q&A, Session Wrap-up
10:20 Break Time to View our Virtual Exhibit Hall
10:50 Chairperson’s Opening Remarks
Alistair Kippen, PhD, Vice President, BioPharmaceutical Development (R&D), Ipsen
10:55 The Delights of Diversity: Application of Native MS in a Biopharmaceutical Development Lab
Dan Bach Kristensen, PhD, Principal Scientist, Symphogen
In recent years native MS has gained significant popularity as a tool for intact mass analysis of biopharmaceuticals. Key strengths include excellent spectral data quality and the ability to interface the MS with a broad variety of separation techniques.
Here case stories and learnings from the transition to native MS in a biopharmaceutical development lab will be presented.
11:15 Using Intrinsic Fluorescence Emission for Analysis of Cell Culture Media and Protein-Based Samples
Alan G. Ryder, PhD, Professor, Nanoscale Biophotonics Laboratory, National University of Ireland Galway
Many important analytes in biopharmaceutical manufacturing are chemically complex such as culture media and proteins and the use of traditional analytical methods can sometimes be problematic for these materials. Therefore, there is a need for rapid
characterization methods for analysing lot-to-lot variance and predicting material/process performance. These materials are intrinsically fluorescent which means using multi-dimensional fluorescence spectroscopy measurements are a viable option
for many applications. Here we describe the benefits and operational use of these methods.
11:35 Improve the Characterization of New Biologics by Knowing Protein Stability First with Prometheus
Peter Fung, PhD, Senior Manager, Customer Marketing, NanoTemper Technologies, Inc.
Everyday researchers face the daunting challenge of creating more effective biotherapeutics. Many candidates fail due to a lack of critical stability information that’s tightly linked to function and efficacy. Scientists deserve a technology
early on in their research that reveals deep bioanalytical characterization. Prometheus quickly and precisely measures conformational and colloidal stability of any protein. Examples of optimizing storage/buffer formulation conditions and functional
screening to identify better biotherapeutic targets using Prometheus will be discussed.
11:55 Q&A, Session Wrap-up
12:10 Lunch Break - Come and View our Virtual Exhibit Hall
12:40 Chairperson’s Remarks
Mary Beth Pelletier, PhD, Director, Global Large Molecule & Gene Therapy QC Analytical Technology, Biogen
12:45 New International Standards for New Challenges: Supporting Monoclonal Antibody Product Consistency in the Era of Biosimilars
Sandra Prior, PhD, Senior Scientist, National Institute for Biological Standards and Control (NIBSC, a centre of the MHRA)
The technical and regulatory developments of the last decade have set the path for a rapidly growing monoclonal antibody biosimilar market. However, the need of ensuring product consistency across manufacturers, jurisdictions and over time has also
become apparent. International standards for monoclonal antibodies are publicly available reference preparations that support bioassay performance and calibration of local reference standards. By defining international units of bioactivity, they
allow global harmonization and traceability of bioassay data contributing to long-term product consistency.
13:05 Progress on Revision of ICH Q2 and the New Q14 Guidance: Changing the Conversation on Lifecycle Management of Analytical Methods
Mary Beth Pelletier, PhD, Director, Global Large Molecule & Gene Therapy QC Analytical Technology, Biogen
Efforts are underway to modernize ICH Q2(R1), the authoritative guidance on analytical method validation, and draft Q14, which will provide guidance on modern concepts in method development. Q2(R2) and Q14 will provide a roadmap for efficient
communication between applicants and regulators on the process of taking an analytical method from definition of intended use through development and validation, ultimately resulting in robust, approvable methods and facilitating management
throughout their lifecycles.
13:25 Q&A, Session Wrap-up
13:40 Break Time to View our Virtual Exhibit Hall
13:55 Chairperson’s Remarks
Mary Beth Pelletier, PhD, Director, Global Large Molecule & Gene Therapy QC Analytical Technology, Biogen
14:00 Analytical Characterisation of Novel High Potency Neurotoxin Therapeutics
David Spencer, Characterisation Manager, Ipsen Biopharm, Tentatively Confirmed
Distinct molecular attributes can critically modulate the physicochemical and pharmacological properties of protein biotherapeutics. For a quality by design approach, a detailed understanding of key structural features and degradation pathways
is required to enable protein design and CMC development to proceed in a rational manner, whereby quality attributes are understood and appropriately controlled. Due to their highly potent nature, and resultant low dose, toxin-based therapeutics
present some unique analytical challenges. Case studies will be presented where insight into quality attributes for toxin therapeutics has been gained using highly sensitive analytical characterisation techniques.
14:20 Cell Population and Fingerprint Analysis for Decision Making Along the Bioprocess Chain of ADC’s and Biosimilars
Christoph Herwig, PhD, Head Research Area Biochemical Engineering, TU Vienna
Bioprocess variations are caused by raw materials, human interactions and the biological system itself. The resulting impurity profile needs to be identified along the process chain and decisions on how to adjust the control strategy of
the subsequent step need to be taken. This contribution aims to show how the complexity of the variations in cell populations and impurity profiles can be identified and reduced by advanced flow cytometry and fingerprint methods. Those
methods feed into an integrated process model for holistic control strategies.
14:40 Q&A, Session Wrap-up
14:55 Virtual Happy Hour in our Virtual Exhibit Hall
15:15 Breakout Discussion Groups
This Virtual 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.
Table: Native MS in Biopharmaceutical Development
Moderator: Dan Bach Kristensen, PhD, Principal Scientist, Symphogen
- How do you use native MS in biopharmaceutical development?
- What separation techniques do you couple to native MS?
- How robust is your native MS platform?
- Are you using native MS to study non-covalent interactions, and if yes, what kind of interactions?
- Do you see a role for native MS in QC (release testing according to specifications)?
Table: Data Science as an Enabler for Good Data and Process Understanding
Moderator: Christoph Herwig, PhD, Head Research Area Biochemical Engineering, TU Vienna
- How can data science improve analytical quality?
- Digital twins and data science workarounds for missing CQAs in control strategies
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Wednesday, 22 july
9:00 Chairperson’s Remarks
Diane McCarthy, PhD, Senior Manager, Global Biologics, U.S. Pharmacopeia
9:05 Standards for Monitoring Process-Related Impurities
Diane McCarthy, PhD, Senior Manager, Global Biologics, U.S. Pharmacopeia, Tentatively Confirmed
The complexity of biotherapeutic products and their manufacturing processes yields a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. Process-related impurities arise
from the manufacturing process and include host cell DNA, host cell protein, and particulates. This presentation will focus on approaches for monitoring impurities, including a discussion of existing USP standards and new standards
under development to support impurity testing.
9:25 PANEL: Detection, Analysis, Risk Assessment and Regulation of Impurities and Host Cell Proteins (HCPs)
Moderator to be Announced
Panelists:Diane McCarthy, PhD, Senior Manager, Global Biologics, U.S. Pharmacopeia
Christoph Herwig, PhD, Head Research Area Biochemical Engineering, TU Vienna
Eric Bishop, Vice President, Research and Development, Cygnus Technologies
9:45 HCP Immunoassays and Orthogonal Methods for Identification of HCP Impurities in Downstream Samples
Eric Bishop, Vice President, Research and Development, Cygnus Technologies
Well-developed and broadly-reactive HCP ELISA are typically used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Regulatory guidelines require use of
orthogonal methods to ensure the HCP ELISA is fit for purpose. AAE and MS have emerged as tools for identifying HCPs that persist through downstream purification processes. These methods complement HCP ELISA and provide a more
comprehensive HCP impurities analysis.
10:05 Q&A, Session Wrap-up
10:20 Break Time to View our Virtual Exhibit Hall
10:40 Chairperson’s Remarks
Shahid Uddin, Director, Drug Product, Formulation & Stability, Immunocore
10:45 New Approaches to Profiling the Solution Behaviour of Therapeutic Proteins
Mark
McCoy, PhD, Principal Scientist, Screening, Target and Compound Profiling, Merck & Co
Protein self-interactions are an intrinsic behaviour that can adversely affect the developability of therapeutic proteins. Our recent work on NMR-based interaction & behaviour assessments permits the simultaneous detection of weak
protein-protein and protein-excipient interactions. We discuss applications to protein formulation optimisation, de-risking mAb co-formulations, candidate developability assessments as well as residue-level structural details that
can guide protein design.
11:05 3D Printed Delivery Systems for Drugs and Biologics
Dimitrios Lamprou, PhD, Reader in Pharmaceutical Engineering, Queen’s University Belfast
Progress in drug design has led to the development of new peptides, proteins, and drug molecules. However, the limited ability to selectively deliver these molecules at well-defined dosing regimens remains a significant challenge.
These challenges can be bypassed by using novel technologies such as 3D Printing/Bioprinting. Various designs with high drug payloads that formulated by 3D printing and characterised using advanced characterisation techniques (e.g.,
μCT, ToF-SIMS) will be discussed.
11:25 Demystifying Label-Free Techniques and Applications for High-Quality Data in a Fraction of the Time
José Catita, PhD, Paralab
Cell line development includes the screening of thousands of clones. The aim is to find the few that are stable, grow as expected, and produce high yields of the bioproduct. Speed up antibody discovery and development by moving
higher quality candidates downstream. How? Carry out expression level analysis label-free in crude samples. Combine it with early-stage glycan characterization both in a high-throughput mode.
11:45 Antibody Formulation Using Bacterial Spore Derived Excipients
Íris Luz Batalha, PhD, Research Associate, University of Cambridge
Dipicolinic acid (DPA) is a small organic molecule that comprises 10-15% of the dry weight of spores and is involved in spore stability and resistance to wet heat. The application of DPA as a pharmaceutical excipient is somewhat hampered by its low aqueous solubility. Through counterion screening studies, we discovered two novel salts of DPA, ethanolamine-DPA and diethanolamine-DPA, which showed improved solubility and significantly reduced the viscosity of high concentration mAb formulations.
12:00 Lunch Break - Come and View our Virtual Exhibit Hall
12:25 Chairperson’s Remarks
To be Confirmed
12:30 Continuous Processing for Vaccine Manufacturing: Challenges and Opportunities
Yan-Ping Yang, PhD, Head of Bioprocess Research & Development, North America, Sanofi Pasteur
Over the last decade, there have been significant investments in continuous manufacturing in the pharmaceutical industry, as it holds great promise to lead the reduction of process steps, smaller footprint, higher product quality,
and better pharmaceuticals for patients. While it’s still in its early stage, the vaccine industry has embraced this concept and is ready to explore the full advantages associated with this approach. This presentation explores
the challenges and opportunities to make continuous vaccine manufacturing a reality.
12:55 Gene Therapy Manufacturing and Technical Development
Diane Blumenthal, PhD., Head, Technical Development, Spark Therapeutics
In the past few years, several cell and gene therapy products have gained regulatory approval in the US and EU with many more in the pipeline. Manufacturers of cell and gene therapy products must tackle technological challenges under
the pressure of short timelines resulting from streamlined clinical development. This presentation will focus on the key technical development challenges facing the industry as product development programs move the into the later
stages of process development and scale-up, process performance qualification and ultimately commercialization.
13:20 Q&A, Session Wrap-up, Host intro to special virtual features
13:35 End of Analytical Characterisation
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