July 2010

Your Partner for High-Quality Protein Hydrolysates

FrieslandCampina Domo, a division of the Ingredients Business Group of Royal FrieslandCampina BV, is one of the operating companies formed as a result of the merger between Friesland Foods and Campina in January 2009 to form Royal FrieslandCampina. Royal FrieslandCampina is a leading global multinational company, with 22,000 employees and revenues of over 9 billion Euros. Formerly Known As DMV International The operating company FrieslandCampina Domo incorporates parts of the companies formerly known as DMV International Nutritionals and Friesland Foods…

Biological Manufacturing

RecipharmCobra Biologics is the specialist biologics division of the Recipharm AB group, one of the leading contract development and manufacturing organisations in Europe. We provide a comprehensive range of services, from early-stage development to the supply of GMP material for Phase I, II, and III clinical trials. We are with you every step of the way. The Market Is Growing — So Are We We have provided contract development and manufacturing services to customers worldwide for more than a decade,…

Demonstrating Millipore Express® SHR Filters Mycoplasma Clearance Capability

          Mycoplasma is known to be a common source of bioprocessing contamination and one of the most difficult contaminants to detect. The effect of a mycoplasma contamination can be catastrophic, resulting in loss of a batch, loss of future production, down-time for investigation and corrective actions, and the potential risk of therapeutic supply shortages to immunocompromised patients. To demonstrate Millipore Express SHR filters’ mycoplasma clearance capability over extended filtration times, two separate Acholeplasma laidlawii retention studies…

Maximize Protein Expression in CHO Suspension Cells

          Transient transfection in mammalian cell lines provides an avenue for researchers to bridge the development bottleneck and shorten the time to usable protein. The method also maintains post translational modifications crucial for biotherapeutic function. Chinese hamster ovary (CHO) suspension cells are especially suited for high-yield production of recombinant proteins, despite being refractory to commonly used transfection methods (e.g., 25-KDa linear PEI). Mirus Bio has developed a more effective alternative, the TransIT-PRO™ transfection kit. Using this…

SAFC Centers of Excellence for Liquid and Powder Manufacturing

Biopharmaceutical manufacturers are under increasing pressure to improve efficiency while maintaining consistent quality and supply of raw materials. SAFC has supplied the top 20 global biopharmaceutical companies for 30 years with custom-made solutions to complex challenges in the manufacture of monoclonal antibodies, recombinant proteins and vaccines. SAFC simplifies the complex task of supplying critical raw materials for your process with worldwide distribution channels and warehousing to ensure inventory where and when you need it. Packaging, testing, and labeling are customized…

Development and GMP Manufacturing of Biopharmaceuticals

With Richter-Helm BioLogics and Richter-Helm BioTec, over 20 years of experience in development and manufacturing of biopharmaceuticals and the innovative strength of high-performance teams are coupled with the solid foundation of the owner companies Gedeon Richter Plc. (Hungary) and HELM AG (Germany). Preclinical to Commercial Supply Richter-Helm BioLogics offers services for development and manufacturing of biopharmaceutical products from customers in the pharmaceutical and biotechnology industries. Richter-Helm BioLogics develops and produces recombinant proteins, plasmid DNA, and vaccines in microbial systems. Richter-Helm…

Cell Harvesting of Biotechnological Processes By Depth Filtration

          In the pharmaceutical industry, there is a strong desire to introduce new drugs on the market as fast as possible (time-to-market) due to time-limited patent protection for new pharmaceutical products. The thinking behind this desire is simple: the sooner a new product can be introduced to the market, the sooner patients can benefit, and the better are the manufacturer’s prospects of financial returns. This consideration, however, should not allow compromises to enter into the manufacturing…

CelliGen® BLU Single-Use, 5-L and 14-L Bioreactor

          Whether you are culturing animal cells in an R&D laboratory or in a pilot production facility, your ability to precisely control all process parameters is critical. Culture yield depends on it, and should your process go into production, FDA requirements mandate it. Therefore the performance of your bioreactor’s controller is as important as a good vessel design, as an optimized medium formulation, or selection of the right cell line. This article focuses on the process…

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…

New Therapeutics Through Fermentation Technology

          Applications of microbial fermentation technology in new therapeutics are expanding. SAFC offers unique cGMP fermentation-based manufacturing capabilities through its Jerusalem facility, including highly potent APIs and biologics. SAFC scientific teams provide a complete range of services, including process evaluation and development, optimization and scale up, technology transfer, manufacturing, analytical testing and regulatory filing to help customers bring new drugs to market faster. SAFC is finding new applications for its expertise in fermentation technology, including the…