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Evolution of upstream intensification: Optimizing perfusion processes with PAT

Process analytical technology (PAT) in bioprocessing has improved manufacturing control while reducing variability and costs in process development and manufacturing. Leveraging PAT with process intensification tools drives robust, efficient, and scalable platforms. In this webinar, Bristol Myers Squibb scientists describe application of PAT to upstream intensification towards developing a mAb N-1 platform process with accelerated timelines. The optimal cell-specific perfusion rate and inoculation density were determined within 2- 3 experiments. The PAT landscape in upstream intensification, the benefits of this approach, and the scale-up from benchtop to manufacturing will be discussed.

Webinars

Viral vector N-1 intensification reduces seed train vessel number, media volume and time

The demand for gene therapy viral vectors requires manufacturing processes to scale up to 2000 L. Viral vector production at this scale requires a 9- to 12-day seed train with two to three seeding bioreactors, increasing the risk of failure and manufacturing cost. Perfusion-based cell culture intensification techniques shorten and simplify the seed train for recombinant proteins and monoclonal antibodies production by reducing time, equipment, bioreactor size and cost while increasing the potential number of batches per year. This webinar will discuss similar efficiency gains for three different viral vectors (lentivirus, AAV8 and AAV9) through intensification using KrosFlo® TFDF® Technology that resulted in reduce train vessel number, N-1 vessel size, media volume and time.

Webinars

Where and When to Apply Upstream Process Intensficiation Technologies

Biopharmaceutical process intensification may be applied to multiple points in the workflow to increase productivity by orders of magnitude for diverse modalities, including recombinant proteins, vaccines, cell therapies, plasmid DNA and cultured meat. This webinar describes application of XCell ATF® Technology to the seed train and the production (N) bioreactor in different modes to create time, cost and facility efficiencies. 15+ years of published application data, implementation in the largest number of commercial processes and proven scaling from 1 L to 5000 L differentiate XCell ATF® Technology from all other upstream intensification methods. Considerations for when and why to apply XCell ATF® Technology in order to meet specific productivity goals will be discussed.

How It Works

Questions and Answers | Morning Session

Questions and Answers session from the morning program of Chromatography Redesigned | July 2022

Technologies Webinars

Advanced affinity chromatography platforms for gene therapies and vaccine responses

The first and only NaOH-cleanable affinity resins for AAV2, AAV8 and AAV9 have been developed using a breakthrough development platform based on unprecedented ligand diversity. Performance metrics for capacity, yield and purity meet or exceed existing AAV resins while also withstanding more than 20 CIP cycles with 0.5 M NaOH. Off-the-shelf resin availability pre-packed in OPUS® Columns, as well as loose resin, enables streamlined implementation. The technical basis of the development platform and example data will be discussed.

Technologies Webinars

Case study: Increasing AAV recovery with new chromatography system technologies

The growing complexity of new modalities is raising the expectations of single-use chromatography technology. The traditional systems still in use however present dozens of built-in challenges all along the flow path. Decades of drive, development, and attention to every detail allowed us to turn these challenges into higher recovery, maintained bioactivity and mitigated risk. This talk takes you from a system in the back of a sprinter van into the facilities of the future. Unique technologies of the systems platform that support higher the increased process efficiency will be discussed in detail. Case studies on the application of these technologies to increasing AAV recovery and analyzing graadient control will also be addressed.

How It Works Technologies

From the ground up: Optimized fluid management through vertical integration

Fluid management often necessitates custom configuration of multiple components to address the operational and facility requirements of a bioprocess. These design and production challenges have been addressed through development of a vertically integrated supply chain and consultative services. Flow paths that include containers, clamps, manifolds, over-molded and hose-barb connections, tubing and valves can be rapidly designed based on a problem statement and manufactured within a single, highly managed supply chain with risk mitigation. In addition, legacy stainless steel process equipment such as totes and carts can now be cost-effectively and rapidly manufactured using polypropylene. A case study that integrates single-use flow paths, 30 automated valves and ergonomic tubing management into a filtration cart constructed from polypropylene with 24 filters will be discussed.

How It Works Technologies

Rapid and simple AAV capture and polish DOE with new digital tools

Fast process development and time to market is crucial for the success of biopharmaceuticals, but often remains a time consuming task due to absence of screening technologies or purification strategies in particular for new biologic modalities in Gene Therapy. This outline describes the advanced and fully automated purification development and optimization for an AAV vector with OPUS® RoboColumns® and Tecan’s Fluent™ robotic workstation.

How It Works Technologies

Process challenges that inspired a new generation of chromatography system technology

Newly designed Artesyn Chromatography Systems from Repligen execute processes with improved yield, reproducibility, and operational simplicity. Over-molded tubing connections eliminate the use of hose barbs and zip ties, which are prone to leaking. Synergistic multi-valve manifolds create a streamlined liquid path without small crevices that typically cause carry-over between buffers. Batch change-overs can be made in under 30 minutes with no tools. The positive impact on process yield and facility output will be discussed.