BPI White Papers

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…

Six Essential Workflow Steps for Paperless, Automated, End-to-End Environmental Monitoring

The consequences of microbiological contamination range from FDA warning letters through product quarantines and recalls all the way to plant shutdowns. This makes quality control, specifically microbiological and environmental monitoring (EM) a mission-critical priority for pharmaceutical and biotechnology drug manufacturing operations.
Are you currently struggling with integrating a home-grown, paper-based or semi-automated EM system to your LIMS only to find out that it’s error-prone and resource hungry? Are your current LIMS or IT systems over extended when it comes to customizing automated, paperless, mobile data capture and workflow management for EM? Are you searching for a proven, best-practices approach to automate EM and LIMS workflows and reporting in a cGMP environment without hindering new product development and production?

This whitepaper provides an overview of the essential workflow steps for implementing a paperless, automated, end-to-end environmental monitoring solution to increase productivity, reduce compliance risk and generate a healthy return on investment.

Anticipating Success: Meeting the Inherent Challenges of Complex Drug Substances

Realizing the full potential of a novel injectable drug compound is no small task. In the months and years that lead from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can slow development to a halt, often at key stages. A careful, systematic approach to identifying where and why these roadblocks can occur is fundamental to staying on course. Just as important is a robust, repeatable process design focused on retaining…

Designing Quality into the Product: Early Developability Assessment in Biopharmaceutical Development

The ultimate objective in the development of any new therapeutic candidate is the validation of its mechanism of action and therapeutic efficacy in a clinical setting. Three important areas of product development critical to determining the success of a new drug candidate are: manufacturing, safety, and delivery of the product to patients. Early attrition observed during preclinical stages can often extend development timelines or require additional process optimization, therefore costing the developer more time and money. It is desirable to…