August 2011

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…

Chromatographic Purification in Downstream Processing

          In many biopharmaceutical companies, chromatographic purification in downstream processing is a key focus for optimization studies. The objective is to streamline the process, which may be achieved by the elimination of intermediate unit operations. The main question, therefore, is how to optimize the adjustment of individual chromatographic process steps. Currently there is a broad range of next-generation sorbents and membranes available for process chromatography. These new chromatography media are characterized by significantly improved performance compared…

CMO Selection Criteria

Selecting a CMOis critical to biotech biologic drug development. A key factor for selecting a CMOis experience. How do you measure experience? It can be measured in many ways, metrics include Number of GMP processes developed by the CMO Number of projects involving your strain Number of projects involving your product type GMP production success rate Number of GMP lots produced. Eurogentec’s Biologics Division is specialized in the manufacturing of biopharmaceuticals from microbial sources such as bacteria, yeast, and biosafety…

Automated Aseptic QC Sampling

Biopharmaceutical companies are increasingly interested in single-use innovations to improve performance and alleviate up- and downstream bottleneck constrictions. High-priority considerations for improvement include decreasing the number of process steps, reducing the risk of cross-contamination, and achieving a higher sterility assurance level. One bottleneck today is a need to collect QC samples at various steps during biopharmaceutical commercial-scale cGMP manufacturing, which typically is a labour-intensive manual activity that holds a potential risk of contaminating product or personnel. Alfa Wassermann Separation Technologies…

Rhobust® Technology

Product recovery is a lengthy and costly procedure consisting of centrifugation and depth filtration steps to remove the cells (clarification), followed by multiple cycles of packed-bed chromatography that bind and separate the target molecule from cell culture medium components (capture). The Rhobust® Technology is a second generation expanded-bed adsorption (EBA) technology that provides an elegant solution to using multiple process steps by combining clarification and product capture into one single step in the first downstream process unit operation. The Rhobust®…