Enabling Faster Feed Strategy

Optimization with Rapid Spent Media

Analysis and Data Visualization Tools

February 23, 2023, at 11 am ET (8 am PT | 5 pm CET)

Optimization of feed strategy to boost process productivity and meet critical quality attributes can greatly benefit from using real-time analytics to gain key insights into the process. Frequent measurements of key nutrients and metabolites in spent media also come with the challenge of generating daunting amounts of data. Bioprocess data visualization can therefore be a cumbersome and lengthy task when multiple dynamic key factors are considered.

We highlight an example of how to facilitate data-driven decisions in near real-time, using at-line measurements of amino acids combined with a straightforward visualization of depletion or accumulation trends throughout the process.

In this webinar, we will preview a novel data analysis tool for the 908 Devices REBEL analyzer designed for use with JMP statistical software. The discussion will focus on applications in cell culture media selection and bioprocess development time course studies aiming to optimize feeding strategy.

2-28-23-Thermo-ATE-Manuel-Matos-HS-Cropped

Marco Baldazzi

DSP Research Laboratory Technician,

Menarini Biotech;

Manuel Matos, PhD, Field Application Scientist, Thermo Fisher Scientific

Beyond Standard Protein A Resin:

Establishment of an Improved DSP

Affinity Platform Step for

Monoclonal Antibodies

February 28, 2023, at 11 am ET (8 am PT | 5 pm CET)

While protein A affinity chromatography is the most commonly used method for monoclonal antibody (MAb) capture in clarified harvest coming from CHO cell cultivation, one significant challenge is the high cost of the media required when using these resins. Therefore, it's crucial to evaluate alternative strategies that may reduce costs and increase productivity without affecting product quality attributes.

In this study, MabCapture^TM C resin has been compared with a Protein A resin used in a DSP platform, showing a higher dynamic binding capacity while keeping the product’s critical quality attributes within acceptable limits. Furthermore, the adsorbent’s robustness and reusability when scaling up makes POROS^TM MabCapture^TM the ideal choice for bioprocessing of MAbs.

Jessica Waller, PhD

Principal Scientist Biologics Development,

Bristol Myers Squibb

New Generation Planova™ S20N

Demonstrates Robust Performance

for Multi-Specific Antibodies

March 1, 2023, at 11 am ET (8 am PT | 5 pm CET)

Bispecific antibody configurations with multi-targeting capabilities are evolving as new generation biologic therapeutics with potential for enhanced efficacy and reduced toxicity. Significant challenges arise with downstream purification of these molecules due to a unique panel of product-related variants or mispaired species that must be monitored and cleared in product pools.

Viral clearance capability is another critical component when developing a downstream process, as mammalian CHO-derived products have an inherent risk for viral contamination. Considering these challenges, a three-step chromatography approach, all operated in bind-and-elute mode, is employed to achieve removal of process and product related impurities prior to the dedicated viral clearance nanofiltration step.

However, the feed stream leading into the viral filtration step can be characterized by high concentration and conductivity from the last chromatography polishing step as well as contain residual impurities that can impact nanofiltration performance.

Thus, there is a need for a robust viral filter for these more complex molecular configurations. We assessed performance of Planova^TM, including the new generation Planova^TM S20N, and flat-sheet nanofilters for a multi-specific antibody. High capacity with minimal decay across Planova^TM 20N, BioEX, and S20N was achieved. Therefore, hollow-fiber nanofilter technology exhibits superior performance and viral removal capability for these more complex therapeutic targets.

Benjamin Osborne, PhD

Senior Application Scientist,

Gator Bio

Accelerating Antibody Characterization

and AAV Analytics Using Next Gen

Biolayer Interferometry (BLI)

March 9, 2023, at 11 am ET (8 am PT | 5 pm CET)

Efficient kinetics and epitope binning studies are critical to biotherapeutics development. Biolayer Interferometry (BLI) is an exceptional tool to easily and quickly obtain results.

In the face of modern throughput challenges, BLI instruments were historically modified to monitor multiple wells per spectrometer, resulting in poor kinetics measurements. To address these shortcomings, Gator Bio has launched the Gator Pro that enables 32 high frequency parallel measurements, alongside a family of novel biosensors, that accelerate biotherapeutic discovery.

In this webinar, we will present kinetics and epitope binning data generated in collaboration with the biopharma industry partners, and quantitation data for as many as 1,152 samples per run.

Thomas Valorose

Senior Product Manager,

Astrea Bioseparations

Advantages of Mixed-Mode

Chromatography in Host

Cell Protein Removal

March 16, 2023, at 11 am ET (8 am PT | 5 pm CET)

Despite considerable advances in downstream purification for MAbs and other recombinant proteins from various expression systems, there remains a need for effective removal of process and product related impurities that could impact product safety, stability and efficacy. Many workflows today utilize multiple steps to polish their product, including ion exchange and hydrophobic interactions. Utilizing mixed-mode purification techniques, Astrea Bioseparations delivers a solution that has several advantages over traditional workflows. By using a mixed-mode approach to purifying the Protein A eluate, multiple sample conditions and process parameters can be accounted for.