August 2011

Performance Enhancing Synergy

          In an effort to mitigate potential risks associated with the introduction of adventitious agents from animal-derived media components, the biopharmaceutical industry has largely shifted to serum-free and/or chemically defined media in cell culture production systems. Successful serum-free media formulations have been developed using plant-derived protein hydrolysates in combination with recombinant supplements such as insulin, transferrin, and human serum albumin, produced in nonanimal systems. The performance benefit provided by any medium supplement is subject to its…

All-in-One Sterile Connect and Disconnect Option Expands Manufacturers’ Flexibility

As single-use systems (SUS) continue to be incorporated throughout bioprocess manufacturing, a wider range of solutions and flexibility is being requested of the connections currently used in single-use systems. Colder Products Company, the leader in single-use connection technology, has been listening to the trends in the marketplace and has responded by expanding its product offering to incorporate a wider range of connections options for the single-use market. AseptiQuik® DC is the first all-in-one sterile connection technology to offer both a…

Optical Oxygen and pH Sensors for Monitoring Biofermentation Processes

          Advances in sensor materials and optoelectronics have enabled new optical sensors for use in biotechnology, food and beverage processing, and more. These fiber optic chemical sensors work by trapping an oxygen-sensitive fluorophore or pH indicator dye in a sol-gel host matrix that is applied to an adhesive patch, the tip of a fiber, or a flat substrate such as a cuvette. The indicator materials change optical properties in response to analytes in their environment, and…

Microcarrier-Based Cell Culture in the XDR Single-Use Stirred-Tank Bioreactor

          Xcellerex’s XDRbioreactors are well suited for production processes that require the use of anchorage-dependent cell lines grown on microcarriers. The bioreactor agitation assembly is the driver for these factors. To assure robust bioreactor operation, the M40Eimpeller was designed to perform well above the minimal mixing constraint for uniform gas distribution and fluid homogeneity and well below the maximum shear constraint to assure a viable and productive cell population. Cell lines such as Vero, MDCK, and…

Zeta Plus™ VR Filters for Viral Reduction

          The FDA requires a minimum of two viral clearance steps operating by different mechanisms to provide assurance of viral clearance. To be considered robust, a viral clearance step must be validated to consistently remove model viruses with at least 2 logs of clearance. When filtration is used, the objective is to obtain effective viral clearance without causing protein (product) loss. 3M Purification Inc. Zeta Plus™ VR Series filters can be used upstream in cell culture…

Bioprocess Scale-Up Using Corning® HYPERStack™ Vessels

In the development of a new biological product, it is important to remember that a successful R&D development project needs to be converted from a bench-scale concept to a bioproduction platform. This process development stage requires identifying ways to increase cell numbers to meet annual dosage demands, as well as to minimize direct contact with the cell product by developing a closed system for all culture manipulations. identifying a bench-scale platform that can scale to CGMP production scale eases the…

ActiCHO Media System

    Fed-batch protein production processes have become more favored because of their simplicity under large-scale conditions. PAA laboratories′ ActiCHO media system is an industrial media package for the cultivation of Chinese Hamster Ovary (CHO) cells in large-scale applications. It contains all media needed from cell thaw until harvest in large scale, which are a stock culture and cell-expansion medium, a production medium, and two appropriate feed media. The formulation of each single medium is titrated carefully to complement the…

Development and GMP Manufacturing of Biopharmaceuticals

Richter-Helm BioTec is a dynamic and expanding biotechnology company located in Hamburg, Germany. Being one of the first biopharmaceutical enterprises in Europe, Richter-Helm has more than 20 years of experience in the development and GMP-compliant production of recombinant proteins, plasmid DNA, and microbial vaccines. With more than 120 employees Richter-Helm offers customized state-of-the-art solutions for all steps in biopharmaceutical projects through contract development and manufacturing services in GMP facilities for microbial production (fermentation scale up to 1,500 L). Beside our…

Single-Use Systems from Start to Finish

          Single-use systems have become all the rage in the biotechnology industry, driven largely by the need to reduce cleaning requirements and associated time, validation, and cost factors with stainless vessels. A well-developed single-use system will ensure lower risk of contamination in manufacturing while eliminating the cleaning process and cleaning validation.   Providing Solutions   Advanced Scientifics provides specific solutions to process needs in fluid transfer and handling, offering flexibility in the design and componentry of…

Comprehensive Global Capabilities and Extensive Scientific Expertise

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 >250 different biomolecules successfully supported annually, Covance Biotechnology Services provide you…