Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development and manufacturing of biotherapeutics. Biopharmaceutical companies have enthusiastically adopted Pall ForteBio’s Octet systems due to their broad utility in protein quantitation and functional characterization combined with no need for labels, real-time monitoring, enhanced throughput, decreased sample preparation requirements, and low cost of operation. Concentration Measurement The Octet platform uses ForteBio’s proprietary Biolayer Interferometry (BLI) technology to measure concentration in 96-well and 384-well…

As the pharmaceutical industry continues to accelerate its focus on developing biological drugs derived using cell culture processes, the ability to accurately monitor osmolality throughout each phase of development, production, and finished product quality control (QC) becomes increasingly important. Osmolality is arguably one of the most important physical parameters to monitor in mammalian cell cultures because of its fundamental implications to the growth, viability, yield, and the close relationship between cells and media. Freezing point osmometers are considered the gold-standard…

Switching to single-use systems can have financial and performance benefits. However, one critical challenge for complete acceptance of single-use systems is assurance of bag integrity — and in turn, product sterility and operator safety. The main risk with single-use technology is associated with leaks that can be induced by transport and handling (1). The second greatest concern regarding the use of disposables is bag breakage and related loss of production materials (2). Limitations of Pressure-Decay Testing Pressure decay is the…

Host-cell protein (HCP) analysis is a big issue when it comes to early clinical testing, design of downstream processes, and quality control of biopharmaceuticals. The decision to use an off-the-shelf generic HCP assay or spend a considerable amount of money for development of a specific HCP assay is often not an easy one. In theory, generic HCP assays should be suitable for all HCP determinations of a specific cell line — independent of cell line modifications, fermentation conditions, and the…

Flexibility has been the key driving force behind the success and growth of Eurofins Lancaster Laboratories’ viral clearance program. “When we introduced four levels of service solutions for viral clearance studies, our clients responded well,” says Dr. Kate Bergmann, manager of viral safety and clearance. “They appreciate that we can tailor our program to meet their specific needs. They can use any of our service levels to address all their scientific, safety and scheduling challenges.” To provide additional capacity, the…

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 are critical in determining the success of a new drug candidate: manufacturing, safety, and delivery of the product to patients. Early attrition observed during preclinical and initial stages of clinical development fundamentally resides in problems with manufacturing, stability, or safety issues. A Potential Risk for Everyone: The Cost…

Figure 1:  For more than 65 years, Kerry’s Sheffield brand has earned its reputation for reliability and excellence in serving the biotech, pharmaceutical, and nutrition markets. We deliver innovative, animal-component– free supplements to help customers increase cell proliferation, extend cell viability, and increase target protein production. Every day we expand our capabilities to meet the changing needs of the biotech market by providing the industry’s most innovative and extensive biotechnologies, including complete supplement systems, hydrolyzed proteins, recombinant proteins, and yeast…

Picture the scene: You head to the boardroom for a meeting with a vendor who promises to optimize your company’s fluid-handling processes. “Sustainability,” he says, enshrined in the spotlight of an overhead projector, “is at the heart of today’s agenda.” You slump into your chair. Sustainability is key to your business, yet efforts to bottle this elusive ideal have so far cost more than they’ve saved. “How can a sustainable bioprocess container solution enhance my business?” you ask. “It’s about…

End oxygen limitations when growing Escherichia coli, Streptomyces, Pichia, Aspergillus, and other high-demand aerobes in shake flasks. Many bioprocesses rely on aerobic growth and protein expression, yet traditional orbital shakers do not provide adequate oxygen. Cultures become oxygen limited. The RAMbio incubator solves this problem by providing active headspace refreshment using low-frequency acoustic energy that aerates standard shake flasks. Why Use the RAMbio? The increased dissolved oxygen provided by the RAMbio may benefit aerobic microbial cultures by Increasing biomass, protein,…

Catalent is your strategic partner for biologic drug development success. We create smart, tailored solutions with our novel SMARTag™ antibody–drug conjugation (ADC) technology, our market-leading GPEx® cell line expression system, expanded biomanufacturing capabilities, and integrated development services to help you get better products to market faster. New SMARTag ADC Technology for Development of Optimized Antibody–Drug Conjugates — Superior Technology for Treatments in Development: Catalent has entered into an exclusive license and comarketing agreement with Redwood Bioscience to offer customers SMARTag…