Cambridge Healthtech Institute’s Inaugural

Analytical Characterisation

Implementing New Technologies and Enhancing Analytical Strategies

March 24-25, 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

Monday, 23 March

Recommended Short Course*

13:00 - 16:00 SC1: Continuous and Integrated Bioprocessing Masterclass

Instructor: Margit Holzer, PhD, Owner, Ulysse Consult

*Separate registration required.

Tuesday, 24 March

7:00 Registration and Morning Coffee

OPTIMISING ANALYTICAL DEVELOPMENT AND CHARACTERISATION

8:25 Chairperson’s Opening Remarks

Alistair Kippen, PhD, Vice President, BioPharmaceutical Development (R&D), Ipsen

8:30 From Sample to Project Decision: Fully Automating MS Analytics of Next-Generation Protein Therapeutics

Nikolov_MiroslavMiroslav 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.

9:00 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.

9:30 In-depth Characterisation with Mass Spectrometry and Orthogonal Methods of Conformers in A Trispecific HIV Antibody

Bruno Genet, Lab Head Mass Spectrometry, Sanofi

The initial characterization of a trispecific anti-HIV antibody led to an aberrant two-peak size exclusion chromatography profile. In such case, a column interaction is suspected, but a possibility of actually having conformers was taken into consideration. We have used both analytical characterization, structural analysis and molecular dynamics to cross all the information. The mass spectrometry toolbox has been largely used with native and denaturing MS, ion mobility and direct infusion to carefully study both the antibody and the antigens interactions.

10:00 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Probing Biopharmaceutical Microheterogeneity Using Native LC-MS

Bones_JonathanJonathan Bones, PhD, Principal Investigator, CCL, National Institute for Bioprocessing Research and Training (NIBRT)

The creation of a native LC-MS method toolbox for high resolution Orbitrap MS-based characterization of biopharmaceuticals will be described, demonstrating the depth of information attainable for a variety of attributes on the intact protein level. Application of native LC-MS for characterisation of drug substance and drug product will be presented. Demonstration of the ability to generate orthogonal and complimentary data using microchip electrophoresis coupled to Orbitrap MS will also be presented.

11:15 The Delights of Diversity: Application of Native MS in a Biopharmaceutical Development Lab

Bach_Kristensen_DanDan 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.

11:45 Presentation to be Announced

 

 

12:15 Luncheon Presentation to be Announced

13:00 Session Break

13:30 Chairperson’s Remarks

Gerard Scheppink, Scientist, Product Characterisation/Analytical Development, Janssen Vaccines

13:35 Using Intrinsic Fluorescence Emission for Analysis of Cell Culture Media and Protein-Based Samples

Ryder_AlanAlan 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.

REGULATORY CONSIDERATIONS

14:05 Genetic Stability Strategies for Developing Vaccines from Early Phase Development to a Commercial Product

Scheppink_Gerard_Gerard Scheppink, Scientist, Product Characterisation/Analytical Development, Janssen Vaccines

Genetic stability characterisation of viral vector-based vaccines is a regulatory expectation. Here we show how the genetic stability of such a vaccine was addressed from first-in-human to PPQ including details regarding qualification of a reduced-scale model, critical quality attribute selection and analytical method selection. The results were used to demonstrate the genetic stability of the seed and its suitability to consistently produce a safe and efficacious product.

14:35 New International Standards for New Challenges: Supporting Monoclonal Antibody Product Consistency in the Era of Biosimilars

Prior_SandraSandra 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.

15:05 Refreshment Break in the Exhibit Hall with Poster Viewing

NOVEL PROTEIN FORMATS

15:45 Analytical Characterisation of Novel High Potency Neurotoxin Therapeutics

Spencer_DavidDavid Spencer, Characterisation Manager, Ipsen Biopharm

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.

16:15 Challenges in Binding and Bioassay Development for Bispecifics

Vollers_SabrinaSabrina Vollers, PhD, Senior Research Officer, Bioanalytical Development, Ichnos Sciences

While bispecifics represent a compelling class of therapeutics, their format inherently presents novel challenges toward the development of binding and bioassays. The binding of multiple targets can essentially double the number of assays required if appropriate strategies are not chosen. Examining case studies of assays developed for bispecifics in detail illustrates various approaches to reliably measure target binding and potency based on mechanism of action.

16:45 Breakout Discussion Groups

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. Then, continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

Table: Native MS in Biopharmaceutical Development

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

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

Table: Visible Particles in Biopharmaceuticals

Anacelia Ríos Quiroz, PhD, Scientist, Group Leader Particle Lab, Pharma Technical Development Europe, Roche

  • What methods should be put place?
  • What are the limitations of compendial methods?
  • Implementing control strategies
  • Lessons learnt from HA interactions

Table: Emerging Technologies for Biopharmaceutical Manufacturing

Dimitrios Lamprou, PhD, Reader in Pharmaceutical Engineering, Queen's University Belfast

  • Examining additive manufacturing
  • Benefits of electrospinning
  • Microfluidics as a tool for drug delivery
  • Delivering drugs with Microelectromechanical Systems (MEMS)

17:30 Welcome Reception in the Exhibit Hall with Poster Viewing

18:30 End of Day

Wednesday, 25 March

8:00 Registration and Morning Coffee

IMPURITIES AND HOST CELL PROTEINS (HCPs)

8:25 Chairperson’s Remarks

Diane McCarthy, PhD, Senior Manager, Global Biologics, U.S. Pharmacopeia

8:30 Standards for Monitoring Process-Related Impurities

McCarthy_DianeDiane McCarthy, PhD, Senior Manager, Global Biologics, U.S. Pharmacopeia

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.

9:00 Presentation to be Announced

9:30 Cell Population and Fingerprint Analysis for Decision Making along the Bioprocess Chain of ADCs and Biosimilars

Herwig_ChristophChristoph 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.

10:00 HCP Immunoassays and Orthogonal Methods for Identification of HCP Impurities in Downstream Samples

Bishop_EricEric 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.

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

PLENARY SESSION:

NEXT-GENERATION PROCESSES AND PRODUCTS

11:15 Chairperson’s Remarks

Jarka Glassey, PhD, Professor, Chemical Engineering, Engineering, Newcastle University

11:20 Current Opportunities and Challenges in Biotherapeutic CMC

Schumacher_RalfRalf Schumacher, PhD, Global Head, Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG

As biologic pipelines continue to grow and diversify, there is an increasing need to standardize, automate and find efficiencies along the entire value chain. This presentation will discuss the current challenges and opportunities in biotherapeutic CMC and the impact new modalities are having on upstream and downstream processing, analytics and formulation. The advantages of predictive process parameters in early stage development and digital development concepts to speed up the CMC development will also be discussed.

11:50 Gene Therapy Manufacturing and Technical Development

Blumenthal_DianeDiane 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 into the later stages of process development and scale-up, process performance qualification and ultimately commercialization.

12:20 Session Break

12:30 BRIDGING LUNCHEON PRESENTATION: Demystifying Label-Free Techniques and Applications for High-Quality Data in a Fraction of the TimeForteBio

Schnerr_HelgeHelge Schnerr, PhD, FortéBio - Molecular Devices (Germany) GmbH

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.

13:00 End of Analytical Characterisation

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