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Oct 08
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08:15 - 09:00

Registration

Showing of Streams
10:40 - 11:20

Morning Coffee

Showing of Streams
12:50 - 14:10

Lunch

Showing of Streams
15:40 - 16:10

Afternoon Coffee

Showing of Streams
17:10 - 18:30

End of Day

08:15 - 09:00 45 mins
Registration
09:00 - 09:10 10 mins
Cell Line Development & Engineering Symposium
Chairperson's Opening Remarks
09:00 - 09:10 10 mins
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Chairperson's Opening Remarks
  • Margit Holzer - Scientific Director, Ulysse Consult
more
09:00 - 09:10 10 mins
Bioanalytical Congress
Chairperson's Opening Remarks
09:00 - 09:10 10 mins
Continuous Manufacturing
Chairperson's Opening Remarks
09:10 - 09:40 30 mins
Cell Line Development & Engineering Symposium
Expanding the CRISPR tool box for CHO cell engineering
  • Helene Kildegaard, Ph.D. - Senior Researcher and Co-PI, Technical University of Denmark
more

Chinese hamster ovary (CHO) cells are widely used in the biopharmaceutical industry as a host for the production of complex therapeutic proteins. Thus, efficient CRISPR tools to improve CHO cell factories are of great interest. Here, our newest development in these tools will be demonstrated. Together with high-throughput technologies and systems biology approaches, genome engineering can pave the way for accelerated generation of desirable CHO cell factories with predicted culture performance.

09:10 - 10:40 90 mins
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Monitoring and Control Strategy for Batch and Continuous
  • Margit Holzer - Scientific Director, Ulysse Consult
more

• Definitions

• Regulatory background

• Overview of Bioprocess Controls for USP and DSP – What & Why & When to measure & control

• Important requirements on process monitoring & control loops – from sampling, measuring, visualization, software, equipment and feed-back or feed-forward controls

• Measuring points, frequency, data treatment and storage

• Control hierarchies

• Routine operation, cleaning, calibration, maintenance

• Main differences between batch and continuous bioprocess control

09:10 - 09:40 30 mins
Bioanalytical Congress
Host Cell Proteins Impurities – A Regulatory View
  • Erika Friedl - Quality Expert, Paul-Ehrlich-Institut
more

Host cell proteins (HCPs) are process-related impurities which could cause immunogenicity and are therefore considered Critical Quality Attributes. Removal and tight control during the manufacturing process development is required. Specific HCP regulatory guidance is provided by the European Pharmacopoeia and the US Pharmacopoeia. Regulatory decisions based on the interpretation of the regulatory framework will be highlighted. Case studies will be presented to emphasize the regulatory expectations regarding the HCP control strategy. Possible specification limits and the type of HCP assays acceptable during product development and the licensing process will be discussed.


09:10 - 10:40 90 mins
Continuous Manufacturing
Continuous manufacturing
more

This workshop will provide a comprehensive discussion about the implementation of continuous processing throughout the biomanufacturing lifecycle. From upstream development to downstream development and the interface between the two, this workshop will provide an overview of the various unit operations in which continuous processing is currently being implemented, as well as the challenges of implementation. A review of enabling technologies and lessons learned, along with implementation case studies will be presented.

09:40 - 10:10 30 mins
Cell Line Development & Engineering Symposium
Cell line development and engineering strategies: Case study from Regeneron
  • Dipali Deshpande, Ph.D. - Senior Staff Scientist, Protein Expression Sciences, Regeneron Pharmaceuticals, Inc
more
09:40 - 10:10 30 mins
Bioanalytical Congress
Understanding which Critical Quality Attributes to measure
  • Christoph Rösli - Senior Fellow, Late Phase Analytical Development, Novartis Pharma
more

In the last years, an extensive set of putative critical quality attributes has been discussed for antibodies. However, the selection of the correct set of critical quality attributes is crucial during product development as well as for the definition of the control strategy. In this presentation the process to identify project-specific quality attributes, the evaluation of their criticality as well as the selection of critical quality attributes measured during release and stability testing is outlined.

10:10 - 10:40 30 mins
Cell Line Development & Engineering Symposium
Spotlight presentation: A representative from Valitacell
10:10 - 10:40 30 mins
Bioanalytical Congress
Spotlight session
10:40 - 11:20 40 mins
Morning Coffee
11:20 - 11:50 30 mins
Cell Line Development & Engineering Symposium
Data driven CLD – integration and translation of omics and big data information to enhance cell line selection and host cell engineering
11:20 - 12:50 90 mins
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
  • Margit Holzer - Scientific Director, Ulysse Consult
more

• Case studies

• Perfusion monitoring & control strategy

• Mab DSP monitoring & control strategy

11:20 - 11:50 30 mins
Bioanalytical Congress
NIST Interlaboratory Study on the Glycosylation of NISTmAb, a Monoclonal Antibody Reference Material
  • Roisin O'Flaherty - Post Doctorate Research Fellow, NIBRT
more

Introduction: Recently, the production of monoclonal antibodies as biologic drugs has expanded dramatically. Associated with this trend has been a sudden increase in the number of laboratories determining a critical and heterogeneous property of these drugs, namely their glycosylation. This, in turn, has led to a proliferation of analysis methods, including high performance liquid chromatography (HPLC), capillary electrophoresis (CE) and mass spectrometry (MS)-based. The comparability of variety of these methods, especially as they vary lab-to-lab, presents a major challenge in understanding the meaning and accuracy of these measurements.

Consequently, an interlaboratory study was conducted by NIST to determine measurement variability in identifying and quantifying N-glycans across laboratories. This work describes results from a recent study on glycosylation analysis of a NIST reference material, NISTmAb, from 73 laboratories worldwide.

Methods: Each laboratory was asked to perform glycosylation analysis of two monoclonal antibody samples, NISTmAb and a glycan-modified NISTmAb, using their own method. A template was provided to report glycan percent abundances and methods used. Laboratories were asked to create separate reports for each method of analysis.

Results: To date, 97 reports were submitted by 73 laboratories. Reports came from Europe (41%), North America (37%), Asia (20%), and Australia (2%). Almost half of the reports came from industry (46%), followed by university (33%), research (11%), government (9%), and hospital (1%) laboratories. Comparison of all the techniques will be provided.

11:20 - 12:50 90 mins
Continuous Manufacturing
Continuous manufacturing
more

This workshop will provide a comprehensive discussion about the implementation of continuous processing throughout the biomanufacturing lifecycle. From upstream development to downstream development and the interface between the two, this workshop will provide an overview of the various unit operations in which continuous processing is currently being implemented, as well as the challenges of implementation. A review of enabling technologies and lessons learned, along with implementation case studies will be presented.

11:50 - 12:20 30 mins
Cell Line Development & Engineering Symposium
Industry perspectives and case studies towards demonstration of monoclonality for biologics manufacture development
  • Amie Lundquist - Scientist, Shire and BPOG
more

In this presentation, we highlight the utility of that imaging technology, describe approaches to verify the validity of those images, and discuss how to present that information within the framework of a biologic filing application. This approach serves as an industry perspective to increased regulatory interest within the scope of monoclonality for mammalian cell culture derived biologics.

11:50 - 12:50 60 mins
Bioanalytical Congress
Growing Pains - A Panel Discussion: The challenges and difficulties of developing a biopharmaceutical product from concept to market and methods to help address them
more

Taking a biopharmaceutical product from concept to market can be a difficult and costly exercise, with the average development cost reported as exceeding $2 billion.1 ­Any method or measurement which can improve the overall cost of development or reduce the time taken to generate a final product can significantly impact the outcomes of a project. This may include improving product stability, increasing product efficacy, or increasing the reliability of the candidate selection process.

In this workshop, Malvern Panalytical has gathered a panel of industry experts to discuss some of the major pain points they have observed in their current workflows. These experts will explain the methods and techniques which they have identified and implemented to overcome these pain points and achieve cost- and time-saving improvements to their development outcomes.

1. DiMasi, J., Grabowski, H., Hansen, R. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ. 2016, May 47:20-33.

12:20 - 12:50 30 mins
Cell Line Development & Engineering Symposium
Spotlight presentation: Assuring and proving monoclonality
12:50 - 14:10 80 mins
Lunch
14:10 - 14:40 30 mins
Cell Line Development & Engineering Symposium
Adapting cell line and clone selection methods and workflows for continuous manufacturing
14:10 - 14:40 30 mins
Bioanalytical Congress
Investigation of Fc Receptor Binding and Pharmacokinetics of Distinct Fc Glycans
  • Marco Thomann - Senior Scientist, Roche Diagnostics GmbH
more

Glycosylation of therapeutic proteins is of importance since it can significantly impact biological properties. Glycosylation is heterogeneous and can be subject to batch-to-batch variability. There is a variety of possibilities to influence and investigate glycosylation. In this talk, the in vitro glycoengineering (IVGE) approach will be very briefly introduced and case studies with new data will be presented, including investigation of glyco-modified antibodies incl. changes in galactosylation and sialylation and its impact on Fcy receptor binding and ADCC activity. Furthermore, new results of a recent study on the impact of certain glycan species on animal PK will be shown.

14:40 - 15:10 30 mins
Cell Line Development & Engineering Symposium
Incorporation of high-throughput and statistical techniques to advance CHO cell line screening and cell culture development
  • Alessandro Mora - Sr. Scientist, UMass Lowell
more

Recent cell culture strategies are increasing throughput and data volume. Because of this, novel statistical analyses must be implemented to maximize the screening and selection goodness, during the development of production CHO cell lines.  In this talk we describe the incorporation of 24-deep-well plates and statistical tools such as multivariate data analysis, data clustering and Design-of-Experiment. The rational adoption of these tools facilitated clone screening and feeding strategies design, and was reasonably predictive of the parameters crucial for process development activities.

14:40 - 15:10 30 mins
Bioanalytical Congress
Multi-Attribute Method (MAM) for Process Development and Product Understanding
  • Carly Daniels, Ph.D. - Senior Scientist, Analytical R&D, Pfizer
more
15:10 - 15:40 30 mins
Cell Line Development & Engineering Symposium
Spotlight presentation: Next generation of automation for cell line development
15:10 - 15:40 30 mins
Bioanalytical Congress
Spotlight session
15:40 - 16:10 30 mins
Afternoon Coffee
16:10 - 16:40 30 mins
Cell Line Development & Engineering Symposium
Industry case study: Overcoming the challenges of cell line development for difficult to express proteins
16:10 - 16:40 30 mins
Bioanalytical Congress
How and when do we use equivalence test instead of test for parallelism? And do we?
  • Jan Amstrup - Principal Scientist, Novo Nordisk
more
16:40 - 17:10 30 mins
Cell Line Development & Engineering Symposium
Alternative mammalian cell lines for mAb production
  • Rolf Kohler - Group Head, Novartis Pharma
more
16:40 - 17:10 30 mins
Bioanalytical Congress
Best strategy to evaluate Biosimilars similarity using functional and binding assays.
  • Bracha Timan - Senior Director, Biologics Assays & Technology, Teva
more
  • Similarity assessment of monoclonal therapeutic drug using functional and binding attributes
  • Challenges in definition of Critical Quality Attributes (CQA) to determine the Quality Target Product Profile (QTPP)
  • Statistical approaches to evaluate analytical similarity
17:10 - 18:30 80 mins
End of Day