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Enabling Continuous Processing Using a Step-by-Step Approach

Mario Philips is Vice President and General Manager of Single-Use Technologies at Pall Life Sciences. In February, he spoke with BPI publisher Brian Caine and editor in chief Anne Montgomery about Pall’s commitment to enabling continuous processing and its development of single-use technologies. In that discussion, he addressed some major process bottlenecks and Pall’s solution to them, including centrifuge replacements by continuous acoustic wave separation, continuous chromatography with multicolumn chromatography technology platform, and a simplified version of tangential-flow filtration. Read…

A Look At Perfusion: The Upstream Continuous Process

Although implementation of continuous manufacturing for biopharmaceuticals is in the early stages, continuous cell culture technology has been around for close to thirty years. Perfusion was initially developed in the late 1980s as a means for increasing protein titers (1). However, high costs driven by media consumption limited widespread commercial adoption. In the same time frame, advances in cell line engineering, media composition, and bioreactor design led to 10-fold increases in titers for batch and fed-batch modes, eliminating the first…

Flexible Automation for Continuous Unit Operations

Continuous processing has the potential to provide significant cost and time savings for biopharmaceutical manufacturing, but that potential can be realized only if appropriate automation solutions are available for continuous flow between disparate upstream and downstream operations. Pall Life Sciences’ Allegro MVP system, a fully automated bioprocessing system designed for use in upstream and downstream single-use processing, enables flexible automation and thus facilitates continuous biopharmaceutical manufacturing. This article presents the results obtained using the Allegro MVP system in combination with…

A comparative study of MiniTEM™ versus DLS Zetasizer Nano and NTA NanoSight NS300 performance when analyzing < 50 nm particles

Characterization and analysis of subvisible particles of biological origin can be challenging or give insufficient information. In this study Adeno associated virus (AAV) particles contaminated by host cell proteasomes are analysed with direct versus indirect methods performed in a standard laboratory setting to reveal the difference in performance and quality of the information obtained. The focus is on the ability to detect the AAV particles of interest and distinguish them from the contaminating proteasomes. The compact, tabletop MiniTEM system enables…

Modification of Glycans in Bioprocessing

This webcast features: Ryan Boniface, R&D Scientist, Thermo Fisher Scientific Protein quality is a topic of increasing importance as quality elements can have a significant impact on clinical behavior of a molecule. This talk will explore approaches to modify glycan patterns contribute to predicting, achieving and maintaining preferred glycosylation profiles. Glycosylation is a key product quality attribute for many biotherapeutic proteins expressed in CHO cells. N-linked glycans may display macro- and micro-heterogeneity; the degree of this variation can depend on…

Bioprocess Insights Webinars

The biopharmaceutical industry has developed into a multi-billion dollar market in just 30 years. Making decisions and setting up strategies in a rapidly changing environment can be challenging. The difference between a good and a great decision can have extensive implications for the future of a company. In this environment, knowledge and experience are what make the difference. Good insights about, for example, technical advancements, process economy implications, and sustainability aspects can help improve the individual decisions and strengthen the…

Ten Tips for Single-Use Biopharmaceutical and Pharmaceutical Tubing Selection

Tubing for Single-Use bioprocess and pharmaceutical applications has particular requirements. Among them are the ability to withstand various sterilization processes, the delivery of favorable test results regarding extractable substances, and the absence of animal-derived ingredients. Flexibility, permeability, performance in pumps, and welding and sealing capabilities are also common considerations. Additionally, these critical industries should be aware of the environment in which the tubing is manufactured, association standards that must be met and costs. One of the most important concerns involves…

Solving Viscosity in Automated Particle Imaging

Micro-Flow Imaging™ (MFI) easily detects particle size and morphology on a wide range of particle contaminants. And when you add the Bot 1 Autosampler to your MFI 5000 Series system, you’ve got the automated go-to method of choice for particle analysis today. Together, this combination lets you quickly screen for any changes in levels of particle contaminants like protein aggregates and silicone oil in your biopharmaceutical formulation. Highly concentrated protein solutions can be a little trickier to analyze with other…

Objective characterization of liposomal drug delivery platforms: Using cryoTEM and designated image analysis software

Quality-critical attributes particular to liposome drug products include physicochemical properties such as particle size distribution and morphology, e.g. their overall shape. Such properties will influence the biological activity and bio-distribution of liposomal-based drug and gene delivery platforms. Analytical techniques that provide objective and reliable information on liposome particle characteristics can thus help to improve product development processes and shorten the time to securing their final quality. Cryo-transmission electron microscopy (cryoTEM) combined with image analysis using proprietary Vironova Analyzing Software (VAS)…

Understanding Single-Pass Tangential Flow Filtration and the New Era of Bioprocessing

Learn how single-pass tangential flow filtration (SPTFF) technology is revolutionizing current and future bioprocessing platforms with its implementations in biotech, vaccine and plasma industries. Adopting SPTFF at process development (PD), pilot, clinical and commercial manufacturing scales has major advantages over conventional approaches. Key benefits include flexible manufacturing, reduced processing volumes, high product recoveries and increased yield, as well as major savings in capital expenditures. SPTFF also enables disposable and/or single-use technology utilization.