Special Reports

Tools to Support COVID-19 Patient Testing

To prepare adequate healthcare measures in the case of a pandemic, vast numbers of people must be tested in order to understand the dynamics and behavior of the infection cycle. The medical staff working under extreme circumstances need basic but reliable laboratory supplies to help contain the pandemic. Read this special report to discover two solutions for COVID-19 patient testing that comply with guidelines from the US Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO). The…

Accelerating the Development and Manufacture of Therapeutics Using the Octet Platform

The high costs of therapeutic discovery, development, and manufacture require improved process efficiencies and economics. Analytical tools that eliminate the need for reagent labeling and enable real-time data visualization save development time and improve efficiencies during process development. The Octet biolayer interferometry (BLI) platform and assays can be used throughout process development and manufacturing, including cell-line development, clone selection, and dynamic binding capacity (DBC) determination for affinity purification columns. The ability of the Octet BLI platform to monitor binding interactions…

New Antibody Formats on the Block:
More Complex Modalities Demand Innovation in Manufacturing and Purification

Some of the latest, most promising therapeutic developments in the biologics industry use antibody fragments — either separate functional subunits of antibodies or recombinant molecules that are composed of immunoglobulin domains. The most popular fragments are antigen-binding fragments (Fabs), variable single-chain fragments (scFvs), diabodies, and nanobodies. Such molecules raise several advantages over their parent molecules for upstream production but pose several challenges for downstream purification. To facilitate antibody-fragment capture, Tosoh Bioscience has developed Toyopearl AF-rProtein L-650F resin. Its ligand uses…

Design and Performance of a New Single-Use pH Sensor with Long Shelf Life and High Stability

Single-use biopharmaceutical manufacturing systems require gamma-sterilizable, highly stable, accurate, and simple-to-use single-use pH sensors with a long shelf life. Herein we report the design and performance of a single-use pH sensor technology optimized for single-use bag applications such as those found in bioreactor and mixing applications. This technology is the basis of Emerson’s Rosemount 550pH Single-Use Sensor. The sensor is compatible with gamma irradiation and can be attached to a single-use bioreactor bag via industry accepted ports. With the incorporation…

Clamp-On Flow Meters for Process Monitoring

Process monitoring entails systematic recording or measurement of an operation or process by means of technical aids. Repeated, regular execution is a central element of that activity. Statistical process control and management help to optimize and stabilize processes. They also ensure appropriate monitoring of threshold values. Ultrasound-based clamp-on flow meters are ideal measuring methods for that purpose because they enable data collection without requiring operators or equipment to intervene in a process. Noncontact flow sensors also combine high precision with…

The Five Heresies of Cell Culture: Debunking Conventional Wisdom

Cell culture and bioprocessing conventional wisdom remains a hurdle for the wider adoption of more precise tools. It has been more than 60 years since any real progress has been made towards creating a more accurate and reliable way of performing cell culture monitoring to better understand the effects of things like pH and oxygen at the pericellular level. At SBI, we’re developing optical sensing technologies that unlock the “black box” of cell culture to bring actionable insights to scientists…

Cell-Line Development: Accelerating Antibody Discovery By Monitoring Titer and Glycosylation with the Octet Platform

Cell line development involves the screening of thousands of clones in an effort to find the few optimal clones that are stable, grow as expected, and produce high yields of the bioproduct. The time it takes from engineering an optimal cell line to the production of the target biologic can be prohibitive and may differ from molecule to molecule. While expression-level analysis like titer screening is carried out early, other critical quality attributes (CQAs) such as glycan characterization are often…

Measuring Cell Density in HyPerforma S.U.B.s with ABER Futura neotf
Single-Use Sensors

Monitoring critical process parameters (CPPs) and key performance indicators in bioreactor control systems is crucial to ensure proper cell growth and protein production. Today, most of the major biopharmaceutical companies employ capacitance measurement, in R&D and through process development to manufacturing. Owing to the increased use of single-use bioreactors and building on Aber’s experience with single-use capacitance sensors, the latest Futura neotf single-use capacitance sensors have been specifically developed for integration into Thermo Fisher Scientific bioprocess containers (BPCs) for use…

Single-Use Systems for Storing and Shipping Frozen Drug Materials

Using presterilized, single-use freeze–thaw systems instead of traditional freeze–thaw platforms that include stainless-steel tanks and bottles can help biomanufacturers manage the quality of their drug substances. Single-use assemblies reduce the risk of cross-contamination, simplify dispensing, and decrease the number of manual interventions during freezing, thawing, handling, and shipping. However, implementing a freeze–thaw process requires careful testing of the physical and thermal properties of single-use systems and related aseptic connectors as well as assessment of drug-substance quality and stability. Such evaluation…

Predicting Viral Clearance in Downstream Process Development

As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require viral clearance validation studies for each biopharmaceutical prior to approval. These studies are typically conducted in biosafety level (BSL)-2 facilities and require large capital and human resources. The use of an accurate, economical, and quantifiable noninfectious viral surrogate would enable downstream purification scientists to study viral clearance throughout process development. This report explores the use of a BSL-1 compatible, noninfectious MVM particles to predict viral clearance results over…