Using a decision criteria matrix this webinar describes optimized upstream and downstream intensified strategies. The presentation also introduces an overview of intensified platform options from process development to manufacturing, featuring and scalable Upstream and Downstream solutions that result in increased productivity of up to 4X while reducing upfront investment cost by 50%. These solutions give multi-product facilities the flexibility to increase annual product turnover by almost 50%. In addition, the incorporation of Data Analytics and Automation tools into the product lifecycle provides robust process control, leading to higher product quality and reduction in the cost of quality.

Speakers:

Priyanka Gupta
Head of Market Entry Strategy, Segment Marketing Protein-Based Therapeutics
Sartorius

Raman spectroscopy is a spectroscopic, RTA, and PAT technology that can be in monitoring bioprocesses in real-time by creating predictive models. This presentation will look at the ability of using Raman to provide real-time trending of data in upstream process in development and manufacturing. The evolution of this technology and implementing ideas such as feedback control will be discussed, along with the lessons learned in the process getting this technology to into the hands of manufacturing.

Speaker:

Nobel Vale
Principle Scientist
Bristol-Myers Squibb

In the new era of complex modalities and COVID-19 pandemic, speed, capacity, efficiency, and robustness are more vital than ever to a successful biotherapeutics development program. Yet CHO cell line selection still represents a painful, costly bottleneck - requiring weeks waiting for cells to expand and processing of hundreds of well plates. Learn how Opto^TM CLD workflow on the Beacon® system integrates cell enrichment, cloning, culture, screening, and selection into a single, automated microscale process that generates the highest titer clones in just a few days. Case studies will highlight how users are accelerating and de-risking their path to IND with capacity for up to 50 campaigns per year, multiple molecules per campaign, and FDA-accepted monoclonality assurance to support regulatory submissions.

Speaker:

Renee Tobias
Director, CLD Product Management
Berkeley Lights

The application of emerging next generation sequencing methods has the potential to revolutionise our understanding of protein synthesis during the production of biopharmaceuticals. This talk will present case studies on the application of ribosome footprint profiling to understand translation elongation and initiation at single nucleotide resolution in Chinese hamster ovary cells.

Speaker:

Ioanna Tzani
Post doctoral Researcher
NIBRT

Despite interest in continuous manufacturing, fed-batch processes are still the workhorse in biopharma production. In this session, we present the latest strategies for selecting your production cell culture medium and for developing feed strategies that result in a high-producing processes for different cell lines. Strategies to intensify fed-batch processes through perfusion in cell banking or seed train will also be covered.

Speaker:

Andreas Castan
Strategic Technology Leader and Principal Scientist
Cytiva

The presentation covers recent advances of Novartis Cell Line Development toolbox of vector elements and novel engineered CHO cell lines, which resulted in increased clone productivity & genetic stability as well as improved product quality for complex therapeutic proteins. Additionally, by combining vector technologies with a robust CHO cell line, we developed a highly accelerated cell line development scenario for antibodies with significantly reduced efforts for the generation of high-producing CHO clones.

Speaker:

David Ausländer
Principal Scientist II, NIBR Biologics Center
Novartis Pharma AG

To solve challenges in cell line development workflows, we developed the UP.SIGHT, which streamlines CLD workflows by automating labor-intensive and time-consuming steps. We combined our patented, highly efficient, fast and gentle single-cell dispensing technology with a novel, superfast, high-quality imaging system that provides a full well image and no need for image stitching. Our all-in-one solution enables nozzle imaging and 3D Full Well Imaging for double assurance of clonality from two independent optical apparatuses, resulting in a probability of monoclonality >99.99%.

Speaker:

Julian Riba
CSO
cytena