BPI White Papers

Purification of Fab and scFv using High Binding Capacity TOYOPEARL® AF-rProtein L-650F Resin

Protein L based affinity chromatography is used for the capture of antibodies and antibody fragments that do not bind to protein A. Unlike protein A and G, which bind to the Fc region of immunoglobulins (IgGs), protein L binds through interactions with the variable region of an antibody’s kappa light chain. TOYOPEARL AF-rProtein L-650F is an affinity chromatography resin that combines a rigid polymer matrix with a recombinant protein L ligand, which is derived from the B4 domain of native…

Three’s Company: Formulation Prep and Stability Screening With Grunt, Lunatic and Uncle

The stability of biologics can be highly dependent on formulation pH. The pH can be screened by buffer exchanging proteins into a variety of buffer salts and running follow-up analytics to determine stability. Current practices for buffer exchange all have limitations. Dialysis requires a large excess of buffer and time. Centrifugal filters and desalting columns are faster, but require more hands-on time. Additionally, all three methods require dilution or concentration steps to reach target protein concentrations. Automating buffer exchange eliminates…

Buffer Selection in Biologics Manufacturing

They’re far less exciting than the life-changing treatments they help create, but buffers play a critical role in upstream and downstream biomanufacturing processes. ANGUS takes you backstage with “Buffers in Biologics Manufacturing” – an in-depth article co-authored by Dr. Dave Green, Vice President of R&D, ANGUS, that explores the important variables to consider when selecting the right buffer (and buffer supplier). And, when it comes to biomanufacturing, we know a thing or two about buffers. Why? Because we invented them.…

Continuous Capture Chromatography, A simple, Robust Approach to Move From Batch to Continuous Capture

Increasing demands for the production of biopharmaceuticals, such as monoclonal antibodies (mAbs), vaccines and recombinant proteins, require new, innovative purification approaches with higher efficiency and productivity while maintaining or reducing costs. One of these approaches is continuous capture chromatography. Continuous capture chromatography, also known as CaptureSMB was developed by ChromaCon AG. CaptureSMB is a 2-column periodic counter current chromatography (2-PCC) process where the first column is fully loaded and breaks through to the second column. The first column is eluted…

Gram Scale Transient Antibody Production and Stable Cell Line Generation Using Flow Electroporation™ Technology

In recent years researchers have turned to transient gene expression (TGE) as an alternative to CHO stable cell line production for early stage antibody development. Despite advances in transfection methods and culture optimization, the majority of CHO-based TGE systems produce insufficient antibody titers (low mg/L level) for full use within the biotherapeutic development pipelines. MaxCyte’s delivery platform for cell engineering is based on Flow Electroporation™ technology and provides a universal means of fully scalable, highly efficient CHO-based TGE for the…

Single-Use Technology: The Next 5 Challenges to Conquer

Now that single-use technology plays a part in nearly all bio-production processes, what is next? Several challenges remain that are still serious enough to delay or even stop the use of single-use technology, which in turn can extend the time to market and increase the cost of lifesaving biopharmaceutical products. Of the existing difficulties, which five are the most critical? This paper considers five existing challenges in the implementation of single-use technology including scale, automation, product compatibility and compliance, speed…

Globalization of Single-Use and an Introduction to the Mobius® MyWay Portfolio

Single-use systems have enjoyed a meteoric rise in recent years and are fast becoming the go-to option for all but the biggest batches in the biopharma industry. But how do you get the most out of these exciting systems? Here, experts track the rapid evolution of single use systems, their impact on the industry and biomanufacturing, and how they will transform future manufacturing operations. Single-use is now becoming well established into an “age of optimization.” More than 90% of biopharma…

Single-Use Powder Containment for Biopharmaceutical Manufacturing

For many years, media and buffer ingredients used in powder form were transferred from stock containers using open scoops, weighed and mixed in buckets or open-top bags, and then carried in and dumped from those buckets or open-top bags directly into production vessels—based on the premise that sterility wasn’t required at that early stage of manufacturing. While much of this process was often carried out in a separate room from the production line to contain airborne contaminants, final transfer to…

Quantum ReNu SU Technology® Validation Guide and Performance Testing Summary

As the use of disposable systems within biopharmaceutical manufacturing has moved from niche preclinical applications to large scale commercial processes. This has led to the requirement for novel technologies that improve processing throughput and allow manufacturers to increase their output. To this end, WMFTG has developed a new pumping technology to enable end-users to meet their downstream processing needs for unit operations such as chromatography and tangential flow filtration (TFF). Quantum allows end-users to use novel peristaltic technology for their…

Achieving Continuous Downstream Bioprocessing Through Multi-Column Chromatography (MCC)

In recent years, improving downstream manufacturing has become an emerging challenge to the biopharmaceutical industry. Initially, the bottleneck in biopharmaceutical manufacturing existed in the output of bioreactors. Due to advances in cell line development and upstream process (i.e., perfusion), the output of bioreactors has increased at a much faster pace than downstream processing capacity. Therapeutic biologics, including monoclonal antibodies (mAbs), represent the fastest growing segment of the pharmaceutical market. By 2019, the biological market is expected to exceed 20% of…