BPI White Papers

The Importance of a One-Stop-Shop-6 Questions to Ask Your Fluid Management Component Supplier

A one-stop-shop fluid management component supplier assures quality, streamlines processes, and limits costs. To be certain you receive the preeminent and safest single-use component, take time to evaluate your fluid-management supplier or a supplier under consideration by asking the 6 important questions we pose in this whitepaper. Your supplier’s answers will help determine if the company is a steadfast partner and one-stop-shop committed to helping you pass FDA validation. You also will learn your supplier’s willingness to provide: the best…

A versatile high capacity, single-use chromatography tool with superior salt tolerance, process robustness and impurity removal

Strong anion exchange (Q) chromatography has become an industry standard in the polish purification steps of mAb production. It is a proven technology to remove DNA, viruses, endotoxins and acidic host cell proteins from process feed streams in flowthrough mode. As the industry pursues an increasing interest in downstream single-use technologies and flexible biomanufacturing due to advancements in cell culture technology and the emergence of cost-sensitive biosimilars, conventional purification technologies present limitations. Despite their high binding capacity, traditional resin-based chromatography…

Hydrophobic Interaction Chromatography: Effects of Mixed Electrolytes on Protein Separations

For HIC separations, parameters other than resin surface modifications can be employed to enhance performance. This application note addresses the electrolyte composition of the mobile phase as one parameter responsible for protein adsorption and desorption. The results presented illustrate the benefits regarding capacity and selectivity in HIC of often neglected salts and their mixtures.

Separation of Monoclonal Antibody (mAb) Monomer from its Half-body using Size Exclusion Chromatography

Recent research has shown an interest in mAb half-bodies as therapeutic vectors as they can be further targeted for conjugation, enzyme labeling, or antibody immobilization. The TSKgel SuperSW mAb HR is able to achieve high resolution between the mAb monomer, the mAb half-body, and fragments due to its unique pore-controlled technology optimized for mAb analysis, as well as its smaller 4 μm particle size.

Applying Disruptive Technologies in Mammalian Cell Line Development

Recombinant monoclonal antibodies (MAbs) maintain their ranking as the best-selling class of biologic drugs. The introduction of high titer bioprocessing for the majority of these MAb products has focused efforts towards maintaining desired quality attributes and reducing time to market. Furthermore, patents covering several blockbuster MAbs and the expression technologies, which facilitate their high-level expression, are due to expire over the next decade. A wave of second generation or “follow-on” biopharmaceuticals/bioprocesses will therefore be vying for market share and regulatory approval. Consequently, should biopharmaceutical manufacturing companies rely on traditional “platform” methods of cell line development (CLD), which are well known but yield extensive variation and unpredictable stability of expression, or invest in emerging technologies, which offer the potential of greater reproducibility and speed? Enabling technologies in this area include host cell engineering, engineered expression vectors, and rapid transient gene expression. Given the well-known mantra “the product is the process”, implementation of these disruptive technologies will require a thorough understanding of how changes at the CLD-phase affect key production process characteristics such as high cell-specific productivity, correct product processing and rapid cell proliferation. Traditionally, CLD optimisation is carried out using a lengthy trial-and-error approach where cells are treated as a “black box” and characteristics are iteratively improved. Further advancement in CLD is therefore likely to benefit from the tools of systems biology. These tools will ensure that future CLD manipulations will be informed by an understanding of the genetic, regulatory, and metabolic networks that determine key process characteristics during a production process.

Monoclonal Antibody Purification with a High Capacity Protein A Resin

“Protein A resins constitute a substantial cost in state-of-the-art mAb purification processes. Factors such as operating cycles, capacity, and mAb titer can have an impact on total costs associated with mAb purification. The purification of a monoclonal antibody from crude feed stock using TOYOPEARL® AF-rProtein A HC-650F, a high capacity protein A resin from Tosoh Bioscience, show that this particular high capacity protein A resin delivers highly pure antibodies at yields approaching 90%.”  

Introducing Nuvia HR-S Chromatography Media

Nuvia HR-S media is a new strong cation exchanger that has been optimized for particle size and chemistry that provides exceptional resolution and high recovery. Nuvia HR-S media demonstrates fast mass transfer kinetics, excellent flow characteristics, and robust chemical stability against common caustic cleaning protocols. Its excellent scalability gives process developers the confidence that results obtained on the bench will be reproducible for large-scale downstream manufacturing. Nuvia HR-S media is the preferred solution for intermediate and final polish applications where…

An environmental life cycle assessment comparison of single-use and conventional bioprocessing technology

Single-use technologies offer an attractive option for biopharmaceutical manufacturing, but their environmental impact needs be considered. This paper documents the findings of a Life Cycle Assessment (LCA) study comparing single-use and conventional bioprocessing technology for the production of monoclonal antibodies (MAbs). The study examines the life cycle environmental impacts at 100 L, 500 L, and 2000 L. The results presented focus on the 2000 L production scale. This assessment was reviewed by a third-party review panel. The results demonstrate that…