Mycoplasma contamination of cell culture (both of primary and continuous eukaryotic cell lines) is common and represents a significant issue of importance in the basic research, development, and production of biologicals. Contamination can alter virtually every physical and chemical property of cells (depending on the contaminating species and the cell type), potentially leading to unreliable results and perhaps unsafe biologicals, biopharmaceutical drugs, or viral vaccines. In fact, contamination may be present with no obvious change…

          Over the past decade the adoption of single-use technologies has moved beyond upstream processes to bulk and filling applications. One example of integrating single-use systems in a final fill operation is to simplify connections to mobile stainless steel transfer tanks. These tanks are designed to transfer product from formulation suites to storage areas and ultimately to filling suites. To allow sterile connection to and from these vessels, designers traditionally add three-way valve assemblies to fill…

          Efficient movement and storage of liquids is critical to modern biotechnology processes. The deployment of single-use containers for this task has become ubiquitous in recent years because they reduce risk while driving down costs in comparison with traditional stainless steel equipment ATMI’s integrity 2-d and 3-d Bioprocess vessel (BPV) products have been developed to meet the demand for cost-effective, scalable, single-use liquid storage containers that are compatible with ATMI’s market-leading range of single-use mixing and…

          As the pharmaceutical industry focuses on developing biological drugs derived using cell culture processes, the ability to optimize the growth, health, and potential yield of the cell line becomes increasingly important. Finding the optimal cell culture media is a daunting and time-consuming process due to the amount of potential media components and the unique requirements of the cell line being researched. Osmolality information is a crucial component to this research because of its close relationship…

          The standard cell line development pathway at many contract service organizations is based solely on selecting clones by growth and productivity with little or no analytical characterization of the expressed protein. The use of protein analytics to support selection of clones that match desired product quality is important for second-generation processes and will be of utmost importance for biosimilar development. CMC Biologics performs sophisticated protein characterization using state-of-the-art analytical equipment combined with our robust cell…

          Eshmuno™ is a new and unique family of ion-exchange resins that are designed specifically for highly productive downstream bioprocessing. The first member of the family, Eshmuno™ S, is a smart cation exchanger designed for fast and efficient purification of antibodies in direct capture and steps following protein A chromatography. Eshmuno™ Q is the newest family member. This smart anion-exchange resin coupled Merck KGaA’s renowned tentacle structure with the new hydrophilic polyvinyl ether base matrix. As…

          BioConnexx specializes in engineering, manufacturing, and distributing reusable and single-use fluid handling components and systems for the biotechnology and pharmaceutical fields. BioConnexx products are designed and manufactured to meet or exceed all standing guidelines and regulations with stringent material selection and carefully considered design. With years of intense and thorough research and engineering, BioConnexx has assembled a complete line of “off-the-shelf” and custom products manufactured under specific guidelines and engineering tolerances and tailored to meet…

          Bioengineering AG has been planning and constructing biotechnological plants for over 35 years. Holistic solutions have become the status quo: from inoculation to harvest, from feed line to CIP-system, and from automation to validation. The know-how acquired over years should not be limited to customers fermenting with Bioengineering equipment. Therefore all Bioengineering components are available as single parts. These custom-made components for a variety of special applications facilitate progress in culture technology.   Operational Safety…

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its comprehensive portfolio of services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Working with clients of all sizes, Covance recognizes that your development program is as unique as the product you bring to our facilities. With over 250 different biomolecules successfully supported annually, Covance Biopharmaceutical Services provide…

Today’s antibodies are sourced from a diverse set of mammalian hosts whose isotypes have different affinities for protein A and protein G. ForteBio’s new protein G biosensor provides an “out-of-the-box” solution for direct quantitation of the mammalian immunoglobulins that do not bind to protein A. Readings can be performed in buffer, chromatography eluents, conditioned medium, and cultured lysates using a convenient 96- or 384- well microplate format. Assay parameters can be adjusted to detect concentrations from 0.05 µg/ml to 2,000…