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Upstream Process Intensification for Virus Vaccine Manufacturing Case Study

Many viral manufacturing processes for animal health have been transferred from the time consuming and higher risk adherent culture systems to more scalable suspension cell cultures. Growing demand and the need for efficient and economic processes drive the continuous search for innovations. This talk describes studies conducted at MSD Animal Health to evaluate the XCell ATF® Technology for intensification of virus propagation on suspension cells.

Webinars

Chromatography system redesigned: Engineered for superior recovery, bioactivity and risk mitigation

Abstract The gene therapy era has brought with it a new set of chromatography yield and operational challenges. Over-molded tubing connections and near dead-leg free valve blocks reduce turbulence, preserving gradient integrity before the column and peak to peak resolution after the column. Quattroflow® pumps and flow path optimization can abate shear stress and increase bioactivity. For set-up, connect closed and sterile pre-assembled kits with 3 AseptiQuik® connections and install in less then 30 minutes with no tools and no wizard. A case study on the positive impact on process yield and output will be discussed.

Webinars

Introducing NaOH-stable AAV affinity resins: the first chapter of a growing catalog

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.

Webinars

Realization of PAT inline using variable pathlength spectroscopy - applications in downstream mAbs and viral vector purification

The first and only variable pathlength analysis technology has been integrated in-line with flow paths for PAT use in downstream unit operations. Rapid and accurate real-time results were acquired on the widest range of samples and concentrations (from less than 1 mg/mL to over 300 mg/mL), revealing previously unrecognized process characteristics.

Webinars

Right-first-time custom affinity resin development with unparalleled ligand library diversity

Traditional approaches to custom affinity resin development often start with a small number of scaffolds, explore limited ligand sequence space and struggle to reach the optimal combination of product specifications. Repligen has resolved these shortcomings by starting the process with >50 multifarious scaffolds and generating unprecedented final ligand library diversity. High binding capacity, selectable pH requirements and caustic stability have been achieved on the first iteration at an unparalleled success rate. Technical features of the development platform, success rate statistics, example performance metrics and economic drivers will be discussed.

Webinars

Rapid customization of non-metallic totes, carts and clean room workstations fit for purpose

Mass customization manufacturing methods have been applied to process equipment creating uniquely designed, nearly degradation-free totes, carts, bio-containers, and clean room furniture.  Products constructed from non-metallic materials provide an advantage through easy customization as well as by eliminating degradation seen on stainless steel units when using traditional cleaning products.   Customization benefits and opportunities will be discussed, as well as durability and material benefits of non-metallic plastic solutions.

Webinars

AAV case study: 3X titer with integrated clarification

Two case studies illustrate multi-fold upstream AAV titer increases for viral vector from HEK293 cells. In addition to productivity gains, XCell™ and TFDF^® technologies clarify conditioned media for manufacturing operational simplicity. Product yield and process economics in the context of the current viral vector supply demand gap will be discussed.

Webinars

Advanced chromatography system design increases yield and reduces deviations

The 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.

How It Works

Welcome to KF Comm 2

KF Comm 2 Software provides a modern, graphically driven interface for process monitoring and control. Create new experiments based on 13 programmed modes, customize batch reports and plug-and-play hardware components. Add an optional 21 CFR Part 11 feature package for regulated environments. Start a run in only 4 clicks Select from 13 pre-programmed modes Operate securely on Microsoft SQL® database for stability