GlycoExpress® (GEX®) technology is a well-established human expression platform for the screening and production of biotherapeutics. By contrast with other human cell lines (e.g., HEK293 and Per.C6) GlycoExpress® expression platform consists of a toolbox of glycoengineered cell lines optimized for producing biotherapeutics with desired glycan structures to improve their clinical performance. Glycotope’s GEX® technology provides an established expression platform proven for different biopharmaceuticals: Antibodies of different isotypes (e.g., IgG, IgM, IgA) Defucosylated antibodies Bispecific antibodies/fragments (e.g., NK cell/T-cell recruiters) Difficult-to-express…

Single-use powder containment is vital in today’s safety-focused manufacturing environment. Preventing product from cross-contamination and reducing airborne particulates is a major concern. Understanding how modern bag designs can increase safety and speed is essential for the industry. We looked at the ease of filling along with dispensing times and product loss. ILC Dover’s EZ BioPac® system shows a 71% decrease in filling times when measured against an industry-standard 2D bag. Because of the nonstatic film, we saw an almost 20%…

For more than 75 years, Kerry has earned its reputation for reliability and excellence in serving the biotechnology, pharmaceutical, and nutrition markets. We deliver innovative solutions to assist customers increase cell proliferation, extend cell viability, and increase target protein production in biotechnological production systems. Every day we expand our capabilities to meet the changing needs of the biotech market. Kerry’s products have evolved with market trends in cell culture over the past fifty years to fulfill our customers’ requirements. Those…

MaxCyte’s delivery platform is a universal, high-performance transfection technology that significantly reduces risk and shortens biotherapeutic development timelines by enabling researchers to Perform early-stage development in the biomanufacturing host cell to ensure identification of high quality, biorelevant candidates Expand the use of transient transfection for faster candidate identification Make rapid and more informed go/no-go decisions through in-depth candidate characterization using transiently produced materials, thus reducing investments associated with stable cell line generation Expedite the transition to biomanufacturing through improved stable…

What factors impact peptone variability? Variability can be linked to at least two critical elements: the biological raw materials and the production site. Raw materials can vary by species of animal or plant sourced, type of components (specific animal tissues as opposed to standardized materials), and geographical origins. Feeding practices also can cause variability. Within a single manufacturer, interbatch variability can be linked to the condition and age of a production site, its level of automation and sophistication, optimized production…

Bovine serum albumin (BSA) is a critical component of many biotechnology and biochemistry systems. BSA is used in a variety of applications, including diagnostics, veterinary medical products, vaccine manufacturing, mammalian cell growth for biopharmaceutical production, and topical and ex vivo medical device applications. The impact of BSA on the performance of these systems is often overlooked and is identified as a possible root cause of variability only after extensive testing and elimination of other system components. There are many different…

Pichia pastoris (Komagataella phaffii) is recognized as a highly competitive expression system for fast and economic production of recombinant proteins. Pichia offers many advantages. It is an established (FDA and EMA approved), safe (generally recognized as safe, GRAS), and highly competitive expression host with strong and effective secretory capacities often resulting in double-digit grams-per-liter product levels in culture supernatant. It combines advantageous properties of prokaryotes and mammalian cells. On one hand, Pichia cultures grow fast and can reach high cell…

Standardizing equipment in biopharmaceutical production streamlines operations, saving end users time and money. An area ripe for standardization is the use of genderless connections, those in which the connector halves are identical in design. Historically, single-use connections have involved male and female halves, but using two different parts can create several inefficiencies and complications, including Increased ordering complexity Greater risk of specifying the wrong system or connection, resulting in downtime and last-minute adjustments Longer lead times Increased stocking requirements. Login…

It’s been over 30 years since the identification and commercialization of protein A. Since its inception, protein A has served as the pinnacle purification platform for the immunoglobulin G (IgG) subclass of antibodies, both monoclonal and polyclonal forms. The introduction of protein A paved the way for researchers and large pharmaceutical manufacturers to develop and commercialize IgG-based therapeutics at both small and large scales, provided by its relative ease of use and well-characterized chromatographic attributes. Unfortunately, the gold standard affinity…

Germany-based em-tec GmbH has been developing and manufacturing products and components for the medical and bioprocessing industry for decades. With many years of experience, em-tec has become known as a strong partner for consulting, development, and production focusing on noninvasive flow measurement systems using the ultrasound transit time principle. The long-established and medically certified bidirectional clamp-on flow measurement system for liquids has been adapted for the special needs of the good manufacturing practice (GMP)–oriented bioprocessing industry. The Flow Measurement System for…