February 2009 Supplement

Medium and Process Optimization for High Yield, High Density Suspension Cultures: From Low Throughput Spinner Flasks to High Throughput Millilitre Reactors

    The most important contributions to high-yield manufacturing processes for the production of recombinant proteins from cultivated mammalian cells have come from the identification of highly enriched and well-balanced media formulations, and fine tuning the process conditions that support high cell culture densities with high specific productivity. The industry standard yield for immunoglobulins or similar molecules derived from suspension-cultivated mammalian cells in bioreactors has risen during the past 20 years from the tens of mg/L to g/L. The more…

Non-Invasive Sensors as Enablers of “Smart” Disposables

    Disposable bioprocessing has come of age. Economic and regulatory conditions are driving the widespread adoption of disposable equipment at all stages of bioprocessing. This review considers the entire bioprocess chain and assesses the status of disposables. In particular, we focus on the current availability and need for additional sensors that will enable the disposable process to be integrated — in compliance — with the latest Process Analytical Technologies. Traditional bioprocessing is highly compartmentalized into upstream and downstream operations.…

Quality by Design: Current Regulatory Status and Future Challenges

    Drug manufacturers face the very real challenge of being both innovative and efficient — having to get products to market quickly — whilst at the same time facing existing hurdles that can limit both of these goals. To manufacture products innovatively and quickly, while at the same time reducing costs and ensuring quality, drug manufacturers must find ways to build quality into their processes. Doing so will aid in product approvals, cut down on poor design issues and…

Robustness of Parvovirus–Retentive Membranes and Implications for Virus Clearance Validation Requirements

    Generic validation is conceivable only through a thorough understanding of the parameters affecting the performance of a process step. In this paper, we provide a detailed example demonstrating the robustness of a virus filtration step. As a first step towards the establishment of a generic validation package for a monoclonal antibody, the robustness of clearance of PP7 across the ViroSart CPV filter was evaluated by changing several critical operational parameters using a simple one-off experimental design. Two different…

Single-Use Technologies and Other Key Drivers in Biomanufacturing

      The biomanufacturing industry has issues. From key drivers and hurdles, to the spectre of leachables legislation and the need for greater harmonization between suppliers, the biotech sector is experiencing a period of growing competition and increasing pressure. But, it is also a market with a future; the commercial success of more than 350 approved biologics has prompted the biotechnology industry to accelerate discoveries in further protein-based therapeutics, placing greater emphasis upon the importance of biomanufacturing. In addition,…

The Maturation of the Biomanufacturing Industry

    In my opening editorial, I referred to an industry in transition. This is being driven by challenges that are by no means unique to biotech: all other industry sectors are experiencing similar pressures. We are seeing the impact in terms of factory design, manufacturing technologies, validation and business processes; these are all themes that have been addressed in this supplement. The big innovation in terms of manufacturing systems has been the wholesale acceptance of disposable manufacturing technologies during…