BPI White Papers

The Path to Genderless Connectors: How Genderless Connectors Lead to More Flexibility, Faster Changeovers and Reduced Costs

Genderless sterile connectors — with their ability to interconnect with each other without male/female limitations — can enhance the flexibility of single-use systems in a wide range of bioprocessing applications. Genderless connectors reduce system complexity, which in turn lowers requirements for inventory management, simplifies operator training and reduces misconnections in the manufacturing suite. In fact, it’s possible this new connector design will drive industry change similar to the transition from stainless, reusable systems to single-use. How can something as small…

New Device for Biomass Monitoring in Shake Flask Culture

We developed a novel system for online biomass measurement in shake flasks based on near 360° scattered light detection. The optosensoric components were combined with the established PreSens SFR Shake Flask Reader technology, so biomass, pO2 and pH can be monitored non-invasively through the flask bottom. First application of the prototype SFR vario on Escherichia coli K12 and Kluyveromyces marxianus culture resulted in highly reproducible online biomass data, with relative errors matching those of standard offline OD measurements.

CaPure-HA™: Purification of MAb Fragments

Making use of chromatography resins with better selectivity, resolution and capacity is one approach to solving the problem not only of aggregate removal, but also that of MAb fragment and other digest products, in a column chromatography purification step. The data presented here demonstrate the capabilities of CaPure-HA to separate Fab and Fc fragments from undigested MAb in a papain digest of an IgG1 monoclonal antibody.

Cadence™ Single-Pass TFF Coupled with Chromatography Steps Enables Continuous Bioprocessing While Reducing Processing Times and Volumes

Continuous bioprocessing initiatives have accelerated in recent years. The transition from batch to continuous bioprocessing offers numerous advantages, including process time savings and lower capital costs due to smaller equipment, tanks, and tubing sizes. Additionally, hold tanks may no longer be needed between unit operations, which can be especially valuable for facilities with limited manufacturing floor space. Furthermore, reduced system hold-up volumes improve product recoveries and also contribute to the smaller system footprint of continuous bioprocessing systems. One unit of…

Volume Reduction and Process Optimization with Cadence™ Inline Concentrator

Pall’s Cadence™ single-pass tangential flow filtration (SPTFF) technology provides a simple solution for continuous concentration and optimization of Downstream Processing (DSP) steps. It eliminates the conventional TFF recirculation loop and allows product to be concentrated in a single pump pass. The single-pass operation eliminates any mixing or foaming issues and exposes the product to low shear; thus, it is optimal for the processing of fragile and shear-sensitive molecules as well. The single-pass feed flow rates are lower compared to conventional…

Exploring Protein Stability by nanoDSF

nanoDSF determines thermal and chemical protein stability with ultra-high resolution and with unmatched reproducibility. The detection of the intrinsic tryptophan fluorescence enables measurements at close-to-native conditions in any buffer, even in the presence of detergents. nanoDSF is applied in antibody engineering, membrane protein research, formulation and quality control.

CaPure-HA™: DoE Optimization of Elution Conditions

Design of Experiments (DoE), also called experimental design, is a statistical approach to process development that has gained wide acceptance in the biopharmaceutical industry. DoE is used to reduce development costs by speeding up the design process and to optimize the parameters of a particular step in the manufacturing process. The data presented here demonstrate the optimization of the CaPure-HA elution using a DoE approach.

Pressure Interruptions (Stop/Start) During Virus Filtration: Assuring Safety Using Robust Process Technology and An Appropriate Risk Mitigation Strategy

Following publications discussing the impact of pressure interruptions on the retention levels of virus filters, an increased focus is being placed on filter users’ own risk mitigation strategies. Users are increasingly requesting technical guidance and support with viral validation from filtration experts, as part of their overall product support package. This guidance document provides a high level of assurance to filter users by demonstrating how combining robust virus clearance technology with the use of standard operating procedures can assure a…

Sterile Vent Filtration on Ozonated Water Tanks

With many pharmaceutical processes requiring large volumes of water, it is critical that any pharmaceutical-grade water used is protected from particulate or microorganism contamination, in order to ensure that process operations do not become inadvertently contaminated. Several approaches can be used to ensure that water remains free from contamination, including the storage of purified water or WFI (Water For Injection) at a minimum temperature of 80°C to discourage microbial growth in the storage system. Another approach is to add ozone,…