Join us December 2-5, 2019 BioProcess International Digital Week, a global 4-day series of live educational webcasts and downloadable resources providing the latest insights for ground breaking bioprocessing, manufacturing, and supply chain strategies. To sponsor future digital events, contact partners@knect365lifesciences.com or request details..

DAY 1 – MONDAY, DECEMBER 2, 2019



GPEx Boost: A Novel Approach for High-Expressing CHO Cell Line Engineering
9am EST / 2pm GMT / 3pm CET

Pharma companies are always examining ways to increase efficiencies and reduce cost of drug development. While cost of goods sold (COGS) can be high for small molecule drugs, biologic development can be even more costly due to the complex nature of the molecules. One way to reduce COGS during biologic development and manufacture is to increase the productivity of the cell line that is expressing the protein, typically a monoclonal antibody. Companies have multiple levers they can pull to attempt to increase productivity, but the cell line development process plays an important role in defining the upper limits of production.

GPEx® cell line development technology is a proven technology that generates highly stable, high titer production cell lines. Recently, GPEx technology and a glutamine synthase knock-out CHO cell line were combined in a unique way to create GPEx Boost. The new technology results in higher specific productivities, higher titers and improved cell growth characteristics compared to GPEx for most protein products. One case study examined a Fc fusion protein that was somewhat difficult-to-express. Using traditional GPEx technology, expression of the stable pool was ~0.6 g/L, and the best expressing clones were ~1.8 g/L. The GPEx Boost stable pool expression for the same molecule was ~4.0 g/L with clonal expression reaching ~5.0 g/L in similar culture conditions. The webinar will describe GPEx Boost technology in more detail and discuss additional case study comparisons.

Speaker:

Gregory Bleck, Ph.D.
Global Head of R&D, Biologics
Catalent

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Novel Approaches and Applications of Single Cell Dispensing in Cell Line Development
10am EST / 3pm GMT / 4pm CET

Demonstrating monoclonality and maintaining cell viability in cell line development is gaining more and more attention by regulatory authorities. Additionally, the prevention of cross-contamination is necessary for successfully generating a high number of clones. This session illustrates the new x.sight series for automatically isolating single cells. The instruments can be used for all common cell types including bacteria addressing microbiome applications. The technology is tailor-made for cell line development and helps you to meet your requirements, especially achieving a very high rate of clonal recovery. In 2018, the majority of top ten pharma companies used cytena’s single-cell dispensing technology to ensure fast antibody development.

Session agenda includes:

  • New technology for isolating single cells including bacteria
  • Working principle
  • How to ensure clonality
  • How to improve efficiency and clonal recovery in cell line development
  • How to prevent cross contamination
  • Isolation and cultivation of anaerobic gut bacteria from mixed samples
  • Customer performance data
  • Conclusions

Speaker:

Julian Riba
CSO
cytena GmbH

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Developing Cell Lines and Processes for Manufacturing Protein Therapeutics: The Hare, the Tortoise or a Hybrid approach?
11am EST / 4pm GMT / 5pm CET

Although antibodies currently dominate the clinic, a shift is being seen in drug development pipelines towards more complex, next generation molecules. These molecules can include engineered elements not previously seen in nature and, as a result, may not express well in current expression platforms.

Creating cell lines for a variety of molecule types therefore requires a toolbox of solutions to get the best out of your molecule. Choosing between a fast, "fixed scope" or a tailor-made program depends on your molecule as well as your specific needs. Complexity often demands the tailored approach - one day being the hare and another day being the tortoise. A hybrid approach can efficiently adapt to an evolving set of circumstances to keep your project on track. In this webinar, we will demonstrate how we can help you translate your idea for a therapeutic protein into a drug product for Phase I.

Speaker:

Alison Porter, Ph.D.
Head of Expression System Sciences
Lonza Pharma & Biotech

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DAY 2 - TUESDAY, DECEMBER 3, 2019



Exploring Media Development and Optimization Strategies for Producing Antibodies with Specific Quality Attributes
9am EST / 2pm GMT / 3pm CET

In this presentation, we examine several case studies that demonstrate the effects of cell culture media on antibody product quality attributes. Methods for achieving key product quality attributes through media development, screening and optimization—including modulation and control of glycosylation—will be explored to demonstrate how media development strategies, utilizing rational media design, can be applied towards the development of effective antibody manufacturing processes.

Speaker:

Tom Fletcher
Scientific Director
FUJIFILM Irvine Scientific

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Accessing Adult Donor Cells for Cell and Gene Therapy Development
10am EST / 3pm GMT / 4pm CET

Several advanced cellular therapy products have received approval and are now commercially available, leading the way in a field poised to erupt. However, there are several big challenges to overcome if the they are to have a significant impact on patients’ lives on a mass scale. One of which is providing consistency and reliability. The goal is to provide a well-defined and tested product with guaranteed outcomes. This is very difficult for cell therapies because of the complexity of cells and their functional characteristics. Understanding and controlling the variability within the cell system will be critical and the sooner this is achieved the faster the research and trial processes can begin.

As the cornerstone to the Cell and Gene therapy development is human cells, this invariably becomes the biggest source of variability entering the development. Whether developing an autologous treatment or an allogenic cell bank. The original starting material, the donor and the way the cells are collected and transported are all critical factors.

Anthony Nolan has been providing cells for therapy, through the facilitation of stem cell transplants for over 40 years. The vision was to establish a register of Human Leucocyte Antigen (HLA) typed individuals who would be willing to donate cells to anyone in need. The primary critical attribute associated to the donor is HLA type. As a result the fate of the graft, and its success, is weighted on donor selection.

More rigorous assessment of products are required in the Cell and Gene Therapy arena if better consistency us going to be achieved. Here we address the Anthony Nolan’s approach to ensuring the starting cell material is best characterized and meets specification to ensure therapeutic success. Learning from our registry and Cord Blood Banking experience in donor selection and testing to launch our Cell and Gene Therapy Service

Speaker:

Dr Diana Hernandez
Head of Immunotherapy
Anthony Nolan Research Institute

Daniel Gibson
Assistant Director, Cell and Gene Therapy Services
Anthony Nolan Research Institute

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Cell Culture Process Optimization for a Late Stage Monoclonal Antibody Program
11am EST / 4pm GMT / 5pm CET

Starting with an un-optimized process for an early stage Mab program, process improvements were investigated to improve productivity, robustness and meet quality criteria. First, media screening studies using a few commercial formulations yielded a media/feed combination that gave almost 3X increase in titer. N-1 conditions were studied to get high cell density using a batch process. The process was scaled up successfully from ambr® 250 to 2000L scale.

Speaker:

Balrina Gupta
Associate Principal Scientist
Merck & Co

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Day 3: WEDNESDAY, DECEMBER 4, 2019



Using Peptones to Achieve Diverse and Demanding Bioproduction Goals
9am EST / 2pm GMT / 3pm CET

As bioproduction requirements advance, it is critical to have consistent, high quality media and supplements that continue to meet evolving industry needs. Peptones have been successfully used in bioproduction applications for more than 30 years to meet diverse and demanding production requirements. Their unique nutritional profiles and usage flexibility make peptones ideal components for creating a robust bioprocess. This webinar will demonstrate the benefits of peptones and how they can be used to enhance process performance and consistently yield a high quality product.

Speaker:

Stacy Holdread
Manager, Research & Development
Advanced Bioprocessing, part of Thermo Fisher Scientific

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Understanding Polysorbate Degradation Due to Process Impurities
10am EST / 3pm GMT / 4pm CET

Polysorbates are a common excipient for biopharmaceuticals and the degradation of these excipients is a common problem. The webcast will cover some common degradation mechanisms, as well as a case study where the degradation kinetics are examined.

Speaker:

George S. Weeden Jr.
Scientist II
Sanofi

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BOKU & Austrian Centre of Industrial Bio Thought Leader Session
11am EST / 4pm GMT / 5pm CET

Session Description TBD

Speaker:

Alois Jungbauer
Professor
BOKU & Austrian Centre of Industrial Bio

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Day 4: THURSDAY, DECEMBER 5, 2019



Solving the Downstream Challenges Associated with an Intensified Upstream Process
9am EST / 2pm GMT / 3pm CET

Intensified cell culture processes present a number of challenges during primary recovery and purification operations as the amassed cell numbers produce an associated increase in solids and, depending primarily on cell viability at harvest, impurities such as host cell proteins (HCPs), DNA and aggregated proteins. Overcoming such challenges requires specific technologies that have the capacity to separate high cell densities from the product stream and preferably some of the smaller impurities along with cell debris effectively.

One such is the kSep from SSB, which is a patented single-use, sterile and closed centrifuge that has shown to effectively clarify high cell density mammalian cell cultures (>100 x 106 cells/mL). Unlike a classical centrifuge, it operates by balancing out centrifugal force and medium flow to keep cells contained in an expanded bed. This only applies low shear forces to the cells to minimize lysis and HCP release. As a result, it dramatically reduces the filter area required for depth filtration.

For direct cell capture post centrifugation with kSep or directly from the perfusion permeate, SSB, in collaboration with NovaSep, offers a high capacity purification system: the BioSC platform with Multi-Column Chromatography (MCC). This flexible, modular system enables users to perform numerous unit operations on the same system in batch, parallel batch or sequential batch modes.

In this webinar case studies of kSep for high cell density clarification and BioSC chromatography will be presented.

Speakers:

Gerben Zijlstra
Global Technology Consultant
Sartorius Stedim Biotech

Ganesh Kumar
Global DSP Technology Consultant
Sartorius Stedim Biotech

Jean-Luc Beulay
Marketing & Product Development Director
Novasep

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Bio Outsource Thought Leader Session
10am EST / 3pm GMT / 4pm CET

Session Description TBD

Speaker:

Speaker TBD

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REGISTER NOW – Please select the webcast(s) you wish to attend and enter your contact details



Day 1 - Monday, December 2, 2019

Day 2 - Tuesday, December 3, 2019

Day 3 - Wednesday, December 4, 2019

Day 4 - Thursday, December 5, 2019