2011

Turn-Key Bioreactor Solutions

          In order to reduce scale-up costs and facility capital expenses, biotechnology companies are adopting single-use systems. To fully enable the single-use paradigm, automation software, hardware, and single-use sensors must be optimized; moreover, both validation documents and materials certifications must be readily available for cGMP implementations. Finesse provides turn-key, configure-to-order measurement and automation solutions for many single-use bioreactor types: “stirred-tank,” “paddle,” or “rocker” systems. The Finesse turn-key system is optimized for each bioreactor type to maximize…

Rapid Cell Line Development with Integrated Protein Analysis

          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…

An Update on the Advantages of Fibra-Cel® Disks for Cell Culture

          With a renewed acceptance of perfusion processesin cell in culture, both in the laboratory and for production applications (1), New Brunswick packed-bed bioreactors using Fibra-Cel® disks are seeing an upsurge in interest. This article examines Fibra-Cel technology and its many advantages, from increased yields of secreted proteins to labor savings in applications ranging from rabies vaccine production to production of the first licensed gene therapy drug.   What Is Fibra-Cel?   Fibra-Cel from New Brunswick…

A Faster, Flexible Alternative to Conventional Outsourcing for Biologics

          For many developers of new biologics, outsourcing clinical or commercial manufacturing with a contract manufacturing organization (CMO) makes good sense. Dozens of capable CMOs offer ready capacity to companies who can’t afford the time, capital or risk involved in building their own biomanufacturing capacity. Of course, the convenience of instant access to a CMO’s infrastructure comes at a steep price: Many CMOs use proprietary cell lines, media, and other technology that will limit a drug…

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…