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.
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…
Pall’s Cadenceâ„¢ 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…
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.
Single-use technology have become indispensable in biopharmaceutical manufacturing. Rentschler is one of the first contract manufacturers worldwide to establish a complete single-use facility for the upstream and downstream processes.
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.
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…
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,…
When developing efficient, high quality biomanufacturing processes, it is imperative that the expression system (‘host cell line’ and ‘vector’) and the process to isolate and identify the best clonal cell line (‘clonal cell line development process’) are of the highest quality. At FUJIFILM Diosynth Biotechnologies a team of scientists has invested more than 20 FTE years undertaking innovation work which has culminated in the development of a new host cell line and vector, along with an optimised clonal cell line…
Unlike chemically synthesized drugs, protein therapeutics are a dynamic heterogeneous mix of active compounds. Due to their complexity, analytical techniques like isoelectric focusing have become indispensable tools in evaluating biologic preparations. The resulting surge in charge isoform analysis has led to major advances in instrumentation, such as Imaged Capillary Electrophoresis (iCEâ„¢)2 . However, to obtain the full benefit from improved instrumentation requires the coinciding development of robust assays. The goal of this note is to promote the successful application of…