Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with more than 20 years of experience in microbial systems. We offer proprietary technologies (ESETEC®, DENSETEC®) that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust and highly efficient processes and GMP-compliant manufacturing for clinical trials and commercial supply. We opened recently a new process-development unit to optimize the entire process-development chain, from gene to purified protein. Asecond extension at the Jena…

          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…

          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…

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…

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…

The following is an extract from a paper presented at the Orlando ISPE Annual Meeting on November 2010 by Dr. John Toynbee. Seal or gasket material protruding into the process flow within pipework carries a number of production issues, many of which have serious cost implications. Areas of seal intrusion or recess are caused by oversized or undertightened gaskets that create a trap at the clamp union. This creates a number of production problems: System drainage and cleaning are compromised…

The risk of viral contamination is a feature common to all biotechnology products produced by processes that use cell lines and raw materials of animal origin. Such contamination could have serious clinical consequences, and worldwide regulatory bodies expect that the viral safety of these products be ensured. Viral clearance studies are performed as one way of demonstrating viral safety. The studies are executed by intentionally adding or “spiking” large amounts of virus into the starting material for individual manufacturing steps…

Disposable cell culture bags are used in conjunction with rocker platforms in an array of cultivation applications (insect and mammalian cell lines, virus, protein expression). Rocking platforms provide the dynamic motion and oxygen transfer for cell culture environments. Disposable culture bags are designed to allow for a large air-liquid surface for oxygen transfer, easy access for sampling/filling, and a sterile environment. Venting issues have been reported in the field during rocking of disposable cell culture bags. Therefore, venting and cell…

Two decades of intensive development of novel expression systems for mammalian cells and microorganisms have led to a significant increase in fermentation titers in the biopharmaceutical production of proteins (more than 20 g/L in microbials and more than 4 g/L in mammalian cell culture). However, dynamic binding capacity of chromatography resins is often limited, and very large chromatography columns are needed to purify such large amounts of target proteins. New paths for cost-efficient purification are therefore needed, including downstream processing…

          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…