NNE Pharmaplan has developed a new facility concept we call Bio on demand™. Facilities based on the Bio on demand™ concept can be established in one to two years. The result is a flexible facility that is fully operational, locally compliant, and with functioning quality systems. The Bio on demand™ concept involves a high degree of single-use technology to ensure cost-effective production and fast establishment. Facilities based on our Bio on demand™ concept can be delivered globally,…

      As the pharmaceutical industry focuses on developing biological drugs derived using cell culture processes, the ability to optimize the growth, health, and potential yield of the cell line becomes increasingly important. Finding the optimal cell culture media is a daunting and time-consuming process due to the amount of potential media components and the unique requirements of the cell line being researched. Osmolality information is a crucial component to this research because of its close relationship between cells…

Automated, nondestructive, rapid sterility and environmental monitoring () Rapid microbial testing methods continue to gain acceptance in pharmaceutical manufacturing, but experience shows that most companies still use traditional methods for their testing. The ability to deliver results in less time than traditional methods provides compelling benefits to manufacturers. Two key areas of microbial testing where these benefits can be realized include environmental monitoring and sterility testing. Microbial testing must be completed throughout the manufacture of pharmaceuticals, including the raw materials…

Challenging conventional process technologies with innovation and forward-looking solutions lead to the next generation of manufacturing processes. With its biotechnology, chemistry, and fine chemistry capability, DSM has an extensive toolbox for developing the most economic and sustainable solutions for customers. DSM’s biotechnology uses microorganisms, enzymes, and mammalian cells to produce novel ingredients and improve existing food ingredients, (bio)pharmaceuticals, plastics, and chemicals. Mammalian Cell Culture–Based Manufacturing A state-of-the-art facility, located in Groningen, The Netherlands, is dedicated to the development, scale-up, and…

    Figure 1: ()   For more than 65 years, Kerry’s Sheffield brand has earned its reputation for reliability and excellence in serving the biotech, pharmaceutical, and nutrition markets. We deliver innovative, animal-component–free supplements to assist customers increase cell proliferation, extend cell viability, and increase target protein production. Every day we expand our capabilities to meet the changing needs of the biotech market by providing the industry’s most innovative and extensive biotechnologies, including complete supplement systems, hydrolyzed proteins, recombinant…

      At ALLpaQ, we’ve enjoyed 12 busy months designing and supplying folding plastic bioprocess containers to the pharmaceutical and biotechnology industries. Thinking outside the proverbial bioprocess box, we’ve also responded to customer demand by growing our consultancy arm. This means we can design your organization’s whole containment needs from start to finish, saving you time and money along the way.   Our Knowledge Is Your Power   With 10 years’ experience developing the preeminent range of plastic large-volume…

        The purpose of this study was to demonstrate compatibility and performance of SoloHill’s Collagen-coated microcarriers in ATMI Lifesciences’ Integrity™ PadReactor™ system. The solid polystyrene core of the collagen microcarriers prevents absorption of serum or cell products into the core of the microcarrier, and the 1.03 specific gravity and 125- to 212-μm diameter allows them to be maintained in suspension with gentle low stirring speed. These solid microcarriers provide an excellent substrate for cell growth. They can…

      Clinical cellular therapy applications often times require a cell expansion or maturation step before use. Traditionally, cell expansion or cell culture is performed in “open” systems including multiwell culture dishes or tissue culture flasks. These “open” steps present risks and are not ideal for larger-scale manufacturing. The new EXP-Pak™ cell expansion container is a closed-system, gas permeable bag intended for expansion and culture of nonadherent cells. EXP-Pak™ bags are made from a unique polyolefin film that permits…

      Unlike traditional pharmaceuticals, cell therapy products (CTPs) require geographically dispersed networks of cell/tissue collection, manufacture, distribution, and clinical treatment facilities. Regardless of source (allogeneic, autologous) or formulation (e.g., fresh, frozen, scaffold), the vast majority of CTPs are clinically administered on a per-patient basis. A CTP will be clinically effective, and therefore commercially viable, only if it is robust enough to be delivered to the patient in an efficient, controlled, and reproducible manner. In the context of CTPs,…

      The large numbers of ex vivo expanded cells that are required in many clinical cell therapy protocols (>100 million per patient) make standard culture conditions problematic and expensive, resulting from the need for extensive personnel and facilities resources and the high potential of contamination. To meet such clinical demand, a robust, automated, and closed cell-expansion method is optimal. The Quantum Cell Expansion System (CES) is a functionally closed, automated, hollow-fiber bioreactor system designed to reproducibly grow both…