POROSâ„¢ XQ is a next-generation strong anion- exchange resin with a fully quaternized amine surface chemistry. It was designed to retain all the beneficial performance attributes of POROS HQ resin, such as resolution capability, flow properties, and physical stability, with the added benefits of higher capacity and salt tolerance. Those were realized by optimizing the pore structure, which drives better access of biomolecules to the surface charge, and by optimizing the amount of surface charge (the ligand density) as measured…
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CaPure-HAâ„¢: DoE Optimization of Elution Conditions
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. With its inherent ability to take into account multiple variables at once, a designed experiment is also used to minimize process variation leading to a more robust manufacturing process. Read…
MAb Aggregate Removal Through Ion-Exchange Chromatography: In Bind/Elute and Flow-Through Mode with TOYOPEARL NH2-750F
A polishing step for the purification of a monoclonal antibody (MAb) using TOYOPEARL NH2-750F was developed. In general, anion-exchange resins can be used in bind and elute (B/E) mode as well as in flow- through (FT) mode. Both options were evaluated. To increase the amount of aggregates of the test sample, a MAb was aggregated by acidic incubation and subsequently diluted to 1Â g/L in loading buffer. Read the full text of this application note in the PDF (Login required).
Avid Bioservices Adds a New State-of-the-Art Biomanufacturing Facility
In July 2015, Avid Bioservices debuted its new state-of-the-art biomanufacturing facility in Tustin, CA. Designed to be one of the first US late phase 3 and commercial production facilities for the exclusive operation of single- use equipment to produce biologics, the 40,000-ft2 build-out of an industrial 110,000-ft2 warehouse provides the perfect setting to install state-of-the-art modular cleanroom bioproduction suites. This new facility incorporates the relatively recent concept of converting an existing building in to a new bioproduction facility, known as…
ThawSTARâ„¢ Automated Cell-Thawing System: Breakthrough Adaptive Sensing Technology for Reproducible, Standardized Cell Thawing
Advances in cryopreservation techniques have been crucial for the substantial progress achieved in many fields, including cell biology research, drug discovery, bio-banking, and assisted reproduction. While cryopreservation techniques have markedly improved, downstream cell thawing techniques have thus far been neglected, even though proper thawing of cryopreserved materials is essential for optimal cell viability. The success of high-promise fields such as cellular therapy and regenerative medicine require reproducible and standardized handling of the therapeutic cells, which includes thawing both during manufacturing…
Producing Value with Boehringer Ingelheim BioXcellenceâ„¢
Boehringer Ingelheim BioXcellenceâ„¢ is your dedicated biopharmaceutical contract manufacturer. As a leading biopharmaceutical contract manufacturer with more than 35 years of experience, it has brought more than 20 biopharmaceutical products to market. Boehringer Ingelheim BioXcellenceâ„¢ offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its facilities in Biberach (Germany), Vienna (Austria), Fremont (USA), and Shanghai (China). Boehringer Ingelheim BioXcellenceâ„¢ can secure product…
Cobra Biologics Expertise, Experience, and Excellence
Expertise Cobra Biologics is a rapidly expanding international contract manufacturing organization (CMO) of biologics and pharmaceuticals for clinical and commercial supply. Cobra has three good manufacturing practice (GMP) approved facilities, each with expertise tailored to serving our customers across the world. We offer a broad range of integrated and stand- alone contract services, stretching from cell line and process development through to fill and finish for the supply of investigational medicinal products and commercial production. Read the full text of…
Application of SoloVPE to UV Concentration Measurement
FUJIFILM Diosynth Biotechnologies is implementing the newest evolution of UV-vis spectroscopy. The simple- to-use SoloVPE system provides accurate concentration measurements in under a minute, whereas comparable UV methods may take over an hour. This difference translates into less time spent on cumbersome in-process testing and more time spent confidently making product. It can measure concentration without the need for dilution, which eliminates pipetting and mixing errors associated with sample preparation. Read the full text of this application note in the…
The Effect of Rocking Rate and Angle on T-Cell Cultures Grown in Xuriâ„¢ Cell Expansion Systems
Ensuring optimal and maximal T-cell production is critical for adoptive immunotherapy and its continued success. The Xuri Cell Expansion System is an important component of the clinical manufacturing process. So we sought to investigate the effect of rocking rate and angle on the expansion of T cells. We used a combination of experimental data and predictive modeling and found that the rocking rate significantly influences the expansion potential of T cells with minimal contribution from the rocking angle. The results…
The Path to Commercial Cell Therapy Manufacturing: Developing a Strategic Roadmap
The road from conception to commercialization of a cell therapy is long, complex, and resource-intensive. To be successful, a cell therapy product must be manufactured to high quality standards using a robust, cost-effective process in a manner that will scale to meet demands and be sustainable over the commercial life of the product. Read the full text of this application note in the PDF (Login required).