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Oct 08
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08:15 - 09:00

Registration

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Showing of Streams
10:40 - 11:20

Morning Coffee

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Showing of Streams
12:50 - 14:10

Lunch

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Showing of Streams
15:45 - 16:15

Afternoon Coffee

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Showing of Streams
17:15 - 18:35

End of Day

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08:15 - 09:00 45 mins
Registration
09:00 - 09:10 10 mins
Bioanalytical Congress
Chairperson's Opening Remarks
  • Christoph Rösli - Senior Fellow, Late Phase Analytical Development, Novartis Pharma
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
09:00 - 09:10 10 mins
Continuous Manufacturing
Chairperson's Opening Remarks
09:10 - 09:40 30 mins
Info
Bioanalytical Congress
Host Cell Proteins 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.


09:10 - 09:40 30 mins
Info
Cell Line Development & Engineering Symposium
Precise and predictable CHO cell line engineering using CRISPR-mediated genome engineering
  • Lise Marie Grav - Postdoctoral Researcher, Technical University of Denmark, Denmark

CHO cells are widely used in the biopharmaceutical industry as a host for production of complex therapeutic proteins. In this regard, efficient genome editing tools to improve CHO cell factories are of great interest. This talk will demonstrate our latest development in genome editing tools, and how the tools in combination with systems biology approaches can pave the way for accelerated generation of desirable CHO cell factories with predicted culture performance.

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

• 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 - 10:40 90 mins
Info
Continuous Manufacturing
Continuous manufacturing

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
Info
Bioanalytical Congress
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.

09:40 - 10:10 30 mins
Info
Cell Line Development & Engineering Symposium
miR-CATCH Identifies Biologically Active miRNA Regulators of the Pro-Survival Gene XIAP, in Chinese Hamster Ovary Cells
  • Paul S Kelly - Senior Postdoctoral Research Scientist, National Institute for Bioprocessing Research and Training, Ireland

microRNAs (miRNAs) have demonstrated great potential for the genetic engineering of Chinese hamster ovary (CHO) cells by augmenting cellular phenotypes such as growth rate and culture longevity. A single miRNAs capacity to regulate multiple mRNA targets can be beneficial by controlling entire molecular pathways or devastating by targeting unwanted genes that positively regulate growth or apoptosis, for example. Reliably predicting miRNA targets can be predictably unreliable as the miRNA: mRNA complementarity relationship has been reported to be vastly non-canonical. Here, we used a technique known as miR-CATCH to fish for and identify a panel of bona-fide miRNA regulators of a known pro-CHO engineering candidate, X-linked inhibitor of apoptosis (XIAP).  

10:10 - 10:40 30 mins
Info
Bioanalytical Congress
Octet® systems get ready for regulated environments - providing data integrity of biomolecule binding responses in real-time and label-free
  • Philip Buckle - Senior Scientist, Fortebio, Pall, 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.

10:10 - 10:25 15 mins
Info
Cell Line Development & Engineering Symposium
ChemStress Fingerprinting: A simple, novel platform using small molecules to control and enhance CHO cell factories
  • Paul Dobson - Data Scientist, Valitacell

The utility of CHO cell factories derives from exploitation of their acquired genetic/functional variation, which enable industry to identify cell lineages with desirable manufacturing properties. Here we discuss novel technologies engineered to provide process control while at the same time enabling optimal leverage of the cell factory using ChemStress fingerprinting.

10:40 - 11:20 40 mins
Morning Coffee
11:20 - 11:50 30 mins
Info
Bioanalytical Congress
NIST Interlaboratory Study on the Glycosylation of NISTmAb, a Monoclonal Antibody Reference Material
  • Roisin O'Flaherty - Post Doctorate, 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.

11:20 - 11:50 30 mins
Info
Cell Line Development & Engineering Symposium
Liquid Engineering: CHO Cell Culture Performance Enhancement Using Small Molecules
  • David James - Professor of Bioprocess Engineering, Chemical and Biological Engineering, University of Sheffield

In contrast to genetic engineering of CHO cells to enhance their functional performance, bioactive small molecule (SM) additives are relatively simple to utilise. As for genetic components (e.g. genes, miRNAs), they can exhibit both generic and specific biological activities; but they can be screened, titrated, combined and deployed during culture with comparative ease. For example, it is now well established that combinations of SMs can control recombinant MAb glycosylation (e.g. galactose, manganese, uridine), or increase productivity (e.g. butyrate, valproate). However, there are no systematic analyses of SM function or platform technologies that permit cell culture engineers to rationally harness the potential of SMs to control manufacturing performance in a cell line and/or product specific manner. We describe the development of a medium to high-throughput platform that enables rapid quantitative assessment of SM additives as a tool to create bespoke media environments designed to engineer cell factory function for optimal manufacturing performance.

11:20 - 12:50 90 mins
Info
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
Monitoring and Control Strategy for Batch and Continuous Bioprocesses
  • Margit Holzer - Scientific Director, Ulysse Consult

• Case studies

• Perfusion monitoring & control strategy

• Mab DSP monitoring & control strategy

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

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 - 12:50 60 mins
Info
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
  • Shahid Uddin - Head of Formulation, MedImmune, UK
  • Amber Fradkin - Director, Particle Characterization Core Facility, Research and Development, KBI Biopharma, Inc.

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.

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

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.

12:20 - 12:50 30 mins
Info
Cell Line Development & Engineering Symposium
CYTO-MINE®: An Integrated Picodroplet System For Single Cell Analysis And Monoclonality Assurance
  • Xin Liu - Principal Scientist, Sphere Fluidics

Cyto-Mine® is the world’s first fully integrated device for high-throughput single cell screening and dispensing, using microfluidic picodroplet technologies. By encapsulating single cells in pico-litre volume droplets, Cyto-Mine® enables rapid detection and sorting of single cells based on measuring their protein (e.g. IgG) secretion level, followed by selective deposition of selected cells into micro-titre well plates. In this talk, we will introduce the key functionalities of Cyto-Mine® and its applications for antibody discovery and development.

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

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.

14:10 - 14:40 30 mins
Info
Cell Line Development & Engineering Symposium
Isolation of production cell lines with high assurance of clonality and stability
  • Dipali Deshpande, Ph.D. - Senior Staff Scientist, Protein Expression Sciences, Regeneron Pharmaceuticals, Inc

Cell line clonality and stability are the foundation of a robust therapeutic protein production process. Constitutive, high level production of recombinant protein in CHO cells incur metabolic stresses to the cells and consequently often lead to genetic instability. Regeneron has developed cell line technologies for efficient isolation of high titer cell lines that are also stable. In these cell lines antibody genes are expressed in production bioreactors but not in cell expansion and banking process. Here we present studies demonstrating that inducible expression cell lines are more stable than constitutive expression cell lines.

14:40 - 15:10 30 mins
Info
Bioanalytical Congress
Multi-Attribute Method (MAM) for Process Development and Product Understanding
  • Carly Daniels, Ph.D. - Principal Scientist, Pfizer

Biotherapeutics comprise a large portion of pharmaceutical development pipelines. With complex modalities ranging from monoclonal antibodies to gene therapies, better process and product understanding are keys to successful therapeutic development. Quality attribute understanding plays an important role. The complexity of biomolecules leads to a number of assays utilized to study and monitor a wide variety of quality attributes. Recently, a multi-attribute method (MAM) has been developed and implemented in order to simplify analyses. MAM uses liquid chromatography-mass spectrometry (LC-MS) peptide mapping methodology to identify and monitor multiple quality attributes simultaneously in a single assay, as well as impurities. We analyzed method performance through multiple intra-lab studies, and assessed method capability in process development and support. Here we discuss the components of MAM, and present case studies of MAM implementation in a biotherapeutics analytical laboratory.

14:40 - 15:10 30 mins
Info
Cell Line Development & Engineering Symposium
Integrated media blending increases efficiency of clone selection
  • Caroline Desmurget - USP Technology Innovation Specialist – Bioprocess Technology and Innovation, Merck Serono SA

In cell line development, numerous evaluation steps are performed to reduce number of candidates until selection of the manufacturing clone. They are often performed in the same chemically-defined media, leading to a selection of the clone that fits the most to the screening medium and not the best clone per se. Media optimization is usually performed at larger scale only once the final clone is selected. By combining clone selection and media blending in conditions mimicking more closely the large scale, the best performing clone may already be selected at the screening stage and reduce further optimization steps.

Media components were classified into 11 different groups, and subsequent blending performed including 93 conditions with about 300 stable clones. The two-week fed-batch cultures were carried out in 96 deep-well plates, using a robotic platform (Biomek, Beckman Coulter). Viable cell density, viability and product titer were monitored throughout the fed-batch.

The media blending produced a substantial growth and productivity diversity for each clone. For example, clone 3 reached a max VCD from 3 to million viable cells at day 10, and produced from 461 to 2178 mg/L mAb in harvest at day 12. Models were created to identify the best media for each of the 24 best clones, amongst which four were kept to perform a stability study and heavy investigation in fed-batches. These clones, as well as their specific media, were tested at larger scale (shake tubes, Ambr, bioreactors) and with different processes/platforms (perfusion, low seeding, high seeding). Interestingly, the use of a specifically selected media allowed to greatly increase performances of three of the four clones evaluated. Titer in final harvest for clone 3 was 29% higher with the best media identified in the previous screening. Moreover, it also allowed to save time compared to a more traditional approach, as the clone was delivered to the process development group with a specific media, and stability study was made in parallel with media testing.

15:10 - 15:30 20 mins
Bioanalytical Congress
Accelerating Biopharmaceutical Development with High-Throughput Glycan Screening and Multiple Attribute Methodology (MAM)
  • Sahana Mollah - Sr. Manager, Global BioPharma Collaboration & CE Technical Marketing, SCIEX
  • Jim Thorn - EMEA Marketing and Applications Leader, SCIEX
15:10 - 15:40 30 mins
Info
Cell Line Development & Engineering Symposium
Engineering the Next Generation of Biomanufacturing CHO Cells
  • Mark Stockdale - Manager – Bioproduction, Horizon Discovery

Aside from process improvements focussed on media and feed strategies the CHO host remains largely unchanged from that which was used thirty years ago. Here I will present Horizon Discovery’s approach to improving our GS knockout CHO K1 cell line using genome engineering approaches such as CRISPR screening and rAAV to provide FTO in biomanufacturing.

15:30 - 15:45 15 mins
Bioanalytical Congress
Integration of Orthogonal Methods to Justify the use of a Host Cell Protein ELISA
  • Eric Bishop - Vice President of Research & Development, Cygnus Technologies
15:45 - 16:15 30 mins
Afternoon Coffee
16:15 - 16:45 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
16:15 - 16:45 30 mins
Info
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

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.

16:45 - 17:15 30 mins
Info
Bioanalytical Congress
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
16:45 - 17:15 30 mins
Cell Line Development & Engineering Symposium
Alternative mammalian cell lines for mAb production
  • Dr Rolf Köhler, PhD - Group Head CLD1, Novartis Pharma AG
17:15 - 18:35 80 mins
End of Day