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Oct 08
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08:15 - 09:00 45 mins
09:00 - 09:10 10 mins
Chairperson's Opening Remarks
09:10 - 09:40 30 mins
Host Cell Protein Impurities – A Regulatory View
  • Erika Friedl - Quality Expert, Paul-Ehrlich-Institut

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.

09:40 - 10:10 30 mins
Understanding which Critical Quality Attributes to measure
  • Christoph Rösli - Senior Fellow, Late Phase Analytical Development, Novartis Pharma

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
Octet® systems get ready for regulated environments - providing data integrity of biomolecule binding responses in real-time and label-free.
  • Philip Buckle - Senior Scientist, Pall FortéBio, UK

Biolayer Interferometry (BLI) technology based Octet® systems have been widely adopted in early research, and development of drug candidates and biotherapeutics. Now, with a comprehensive set of tools for compliance, this label-free technology is gaining traction in process development and quality control (QC) labs for concentration analysis in cell culture and purification, for kinetic and potency analysis of drug-target and drug-Fc receptor interactions, and for stability analysis by assessing changes in activity in stressed and forced degradation samples. Discover the go-to solution providing versatility and flexibility necessary in development combined with rigor and simplicity needed in a QC environment.

10:40 - 11:20 40 mins
Morning Coffee
11:20 - 11:50 30 mins
NIST Interlaboratory Study on the Glycosylation of NISTmAb, a Monoclonal Antibody Reference Material
  • Roisin Flaherty - Post Doctorate Research Fellow, NIBRT

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.

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

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.

12:50 - 14:10 80 mins
14:10 - 14:40 30 mins
Investigation of Fc Receptor Binding and Pharmacokinetics of Distinct Fc Glycans
  • Marco Thomann - Senior Scientist, Roche

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
Multi-Attribute Method (MAM) for Process Development and Product Understanding
  • Carly Daniels, Ph.D. - Senior Scientist, Analytical R&D, Pfizer
15:10 - 15:40 30 mins
Spotlight session
15:40 - 16:10 30 mins
Afternoon Coffee
16:10 - 16:40 30 mins
How and when do we use equivalence test instead of test for parallelism? And do we?
  • Jan Amstrup - Principal Scientist, Novo Nordisk
16:40 - 17:10 30 mins
Best strategy to evaluate Biosimilars similarity using functional and binding assays.
  • Bracha Timan - Senior Director, Biologics Assays & Technology, Teva
  • 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 - 18:40 90 mins
End of Day One