July 2010

Integrityâ„¢ 2-D and 3-D Bioprocess Vessels

          Efficient movement and storage of liquids is critical to modern biotechnology processes. The deployment of single-use containers for this task has become ubiquitous in recent years because they reduce risk while driving down costs in comparison with traditional stainless steel equipment ATMI’s integrity 2-d and 3-d Bioprocess vessel (BPV) products have been developed to meet the demand for cost-effective, scalable, single-use liquid storage containers that are compatible with ATMI’s market-leading range of single-use mixing and…

Nonmetallic Fluid Handling Components and Systems

          BioConnexx specializes in engineering, manufacturing, and distributing reusable and single-use fluid handling components and systems for the biotechnology and pharmaceutical fields. BioConnexx products are designed and manufactured to meet or exceed all standing guidelines and regulations with stringent material selection and carefully considered design. With years of intense and thorough research and engineering, BioConnexx has assembled a complete line of “off-the-shelf†and custom products manufactured under specific guidelines and engineering tolerances and tailored to meet…

Biopharmaceutical Product Development

Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides, and other biotechnology-derived active materials and small molecules — helps to maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and drug product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists, and pharmaceutical scientists provide the…

How to Balance High-Titer Processes with Consistent Quality?

          The high cell culture process (XD®) is a continuous process in which both cells and product are retained in a stirred-tank bioreactor using suspension mammalian culture. This is accomplished using a retention system: Fresh medium is continuously supplied, and metabolic byproducts are withdrawn and discarded through the retention system. XD® provides a controlled environment that leads to consistent product quality in terms of bioactivity, glycosylation pattern, and other product characteristics. Moreover, XD® technology is independent…

Turn-Key Bioreactor Solutions

        top) and TruBio µC (bottom ()   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…

Products and Services Designed to Facilitate Cell Culture Media Development

In response to the biopharmaceutical market needs, the focus of Irvine Scientific today is to provide chemically defined and animal-derived component-free cell culture media for use in the production of recombinant proteins. Drug development companies that do not invest in the costly and complex work of media development can rely on the services of Irvine Scientific to obtain and optimize formulas for their production cell lines. As the leader in rapid turn-around time for providing specially formulated products to clients,…

Sustainability and Corporate Responsibility

As the adoption of single-use products continues to grow at a very fast pace in the biopharmaceutical industry, customers and suppliers are becoming increasingly aware of the potential impact of these products on the net environmental footprint of operations. At Millipore, a key goal is to design and manufacture products with the lowest carbon and water footprints possible and to ensure that these products are managed in the most environmentally friendly way. Millipore’s sustainability vision calls for the company’s operations…

Mobius® CellReady Single-Use 3-L Bioreactor

The Mobius Cellready 3-L bioreactor is a single-use, stirred-tank bioreactor ideal for bench-scale cell culture of mammalian cells. The Mobius Cellready bioreactor is preassembled and gamma-irradiated to reduce set-up and cleaning times compared with glass stirred- tank reactors. It can be used right out of the box, and after a simple set-up, turn-around can be achieved in as little as a few hours. The Mobius Cellready bioreactor has the benefit of single- use technology coupled with the familiarity of bench-top…

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-PROâ„¢ transfection kit. Using this…

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…