Perfusion cell culture processes help saving lab space, increasing volumetric productivity, achieving more consistent product quality, and improving production of less stable proteins. Experimentation at small and bench scale is crucial for the cost-efficient development of bioprocesses, which then can be transferred to larger production volumes. In this webinar we present cell retention technologies suitable for small and bench scale bioprocessing. We show a case study of an ATF-based CHO cell perfusion process at a working volume of 1 L.

Key Topics

• Connection of an ATF-2 cell retention device with Eppendorf bioprocess systems
• Bioprocess system technical requirements and configurations
• Analysis of process performance: Cell growth, metabolite concentrations, and product formation
• Other cell retention technologies, including packed-bed bioreactors and microcarrier spin filters

Speaker:

Amanda Suttle
Bioprocess Research Scientist
Eppendorf Inc.

Horizon Discovery has optimised cell-based assays which will be combined with our expertise in CRISPR screening to identify novel genetic targets that will improve the CHO cell host for biomanufacturing. We will describe the outcomes of our proof of concept work and how we intend to partner with companies interested in being at the forefront of innovation in this field.

Speaker:

Dr. Jamie Freeman
Product Manager
Horizon Discovery

This session will discuss an evaluation of the Beacon® platform and how it was able to identify the highest quality clones in just 5 days. Data will be shared that shows improved performance and timeline compression.

Speakers:

Rachel Ferguson
Associate Scientist III, Cell Line Development
Biogen

The formal requirements for qualifying materials and suppliers are outlined in regulations from various legislatures. However, as an end-user it is important to assess how well materials are understood by the suppliers who manufacture them, in addition to whether they are compliant with the formal requirements. This session will provide will provide some points to consider when taking a science and risk based approach to material selection and supplier qualification for biopharmaceutical manufacture, with a focus on advancing understanding of the material properties, how they may vary, how they are managed by the manufacturing processes and how they may impact the end-user's process performance and ultimately product quality, and how they are supported in the event of issues./p>

Speaker:

Duncan Low, M.A., Ph.D
Independent Consultant
Claymore Biopharm LLC

Duncan Sinclair
Agarose Plant Manager
Purolite Life Sciences

With the need for safer and more effective biotherapeutics, the emergence of gene therapy products, the continual increase of biosimilars, as well as legacy product improvements, the requirement for more specialised and individual products and/or processes to become more agile yet staying cost effective is needed. To keep up with these trends, companies are being required to rethink their processes including the purification steps involved. To support the trend in specialised and ‘tailored’ adsorbents, Prometic Bioseparations Ltd. (PBL) have accumulated a wealth of experience as an expert in affinity chromatography with several successful partnership projects in industrial-scale chromatographic processes not only for purification of proteins, but also in the removal of contaminants such as prions, endotoxins, and isoagglutinins.

In this presentation we will give an insight into the process PBL have established to develop an adsorbent, including all the steps from initial screening and the identification of ligands, through ligand development and optimization, to tech transfer, validation and final product which includes packing development into a pre-packed column ready for manufacture. Prometic Bioseparations Ltd have the capability to turn research into a realisation

Speaker:

Buzz Lobbezzo
Product Support & Development Manager
Prometic Bioseparations

Session Description to come

Speaker:

Sigma S. Mostafa, PhD
Vice President, Process Development
KBI Biopharma, Inc.

Process Intensification is a major trend in biomanufacturing as outlined in the BPOG roadmap for process technologies. This webinar will provide a practical overview of the equipment and supporting services that Sartorius Stedim Biotech offers for Intensifying Cell Culture Processes.

Several novel tools to more efficiently develop intensified upstream processes have recently been launched. How they can be applied will be presented here. In house as well as customer case studies will be illustrating e.g. the use of the new ambr15 system for clone and media screening under perfusion conditions, the use of ambr250 HT perfusion for process development, as well the available cell line generation services for Intensified Processes.

Furthermore, novel manufacturing scale tools and case studies thereof will be presented. These case studies include examples of the new Rocking Motion (RM) Perfusion bioreactor for seed train intensification and examples of intensified Cell Cultures in the Main Stirred Tank (STR) Bioreactor 3.

Speaker:

Gerben Zijlstra
Global Technology Consultant, Intensified & Continuous BioManufacturing
Sartorius Stedim Biotech

Industrial grade autonomous robots can find their way around a facility to an accuracy of 1mm, have an arm accuracy of 0.1mm and are safe to operate next to humans. Not many people know this technology exists and even fewer of them have realised the potential. This presentation seeks to present a vision for the future, outlining where this technology could be employed and thus radically changing how a Biologics facility could operate in 10 years time.

Speaker:

Dave Wolton
Operations Consultant
PM Group – Dublin Ireland

Several important trends have been observed in bioprocessing towards more robust and automated operations. Continuous bioprocessing and data acquisition as well as the utilization of data- and knowledge-driven tools for process analysis and control thrive towards the standards of industry 4.0. Based on industrial case studies this presentation will highlight the enabling role of advanced process modeling including Raman based soft sensors for bioprocess digitalization and automation. Thereby, the importance of several model-assisted steps in data organization, alignment, pretreatment and eventually analytics will be discussed to transfer data through information to valuable knowledge and decision support.

Speaker:

Dr. Alessandro Butté
Senior Scientist and lecturer at ETH Zurich
Co-founder and CEO of DataHow

This webinar will describe the use of MS based analytical techniques as an orthogonal approach to HCP-ELISA and how, through the availability of new technologies and more specialized software, MS can be applied to examine HCP profiles as fully as possible.

The webinar will include a discussion of the following topics:

• Protein library generation
• MS-HCP identification techniques
• Software considerations
• Orthogonality in HCP detection techniques
• Detection limits and coverage of HCPs of specific interest (e.g. enzymatic, immunogenic)
• When to include HCP-MS in your development programs

This webinar will benefit all scientists involved in drug development and manufacture, downstream processing and quality control.

Speakers

Christina Morris
Senior Scientist
BioPharmaSpec

Jillian Roamer
Senior Scientist
BioPharmaSpec

High-throughput testing in bioprocess development generate large number of samples. However, immunoassays for impurity testing, titer and affinity are often manual, resulting in high assay variability and low productivity.

Gyrolab® immunoassay platform is an open platform allowing for establishment of in-house assays in combination with ready-to-use kits for HCP detection and Protein A and IgG titer measurements. Gyrolab systems are increasingly used by biopharma companies to maximize analytical productivity. Automation, a wide dynamic range, matrix insensitivity and software support for analysis of dilutional linearity and spike recovery data minimizes the workload associated with many bioprocess immunoassays.

In this presentation we will describe Gyrolab® technology and show data generated with Gyrolab kits as well as with assays developed by our customers.

Educational value:

• Learn how to develop customized Gyrolab assays for impurity testing, product titer and affinity
• Hear about how to automate your HCP analysis workflow using Gyrolab systems
• Learn how Gyrolab software supports Data Integrity and 21 CFR part 11 Compliance
• Have the opportunity to ask questions during the session

Speaker:

Ann-Charlott Steffen, PhD
Senior Scientist
Gyros Protein Technologies

Cell potency assays for determining biological activity are an important part of establishing safety and efficacy profiles of biologic drug products (ICH Q6B Guidance). These cell-based potency assays are key to characterisation programs, support of changes in production processes, product release and stability programs. Developing and maintaining a cell potency assay across its lifecycle can be challenging and this webcast covers the critical points in the evolution of an assay from the first steps in method development, method transfer through to longer-term assay maintenance where careful consideration of the regulatory issues and implementation of scientifically robust approaches are key to a well-performing assay.

Speaker:

Tom Miles
Potency Assay Team Leader, Biologics Characterization
Intertek Pharmaceutical Services