Fill/Finish

Strategies for Implementing a BPC in Commercial Biologics Manufacturing

Biopharmaceutical manufacturers use a range of bioprocess containers (BPCs) during the production and storage of biopharmaceuticals. Plastic bags, bottles, flasks, and carboys are all types commonly used in bioprocessing (1). A suitable BPC must be able to maintain aseptic integrity and be constructed of materials that will not harm product efficacy and/or purity. The trend of “single-use” or “disposable” BPC technologies in the biopharmaceutical industry enables greater flexibility and better use of production facilities that are increasingly designed for multiple…

Large-Scale Freezing of Biologics

Production of biologics is expensive. To optimize capacity use, bulk protein solution produced in manufacturing campaigns is often converted into drug product based on market demand, so it may be stored for relatively long periods. To decouple production of bulk solution from that of a final drug product, the bulk is often stored frozen. Transport of frozen bulk between sites offers several practical advantages over bulk transport in the liquid state (2–8 °C). Maintaining 2–8 °C requires accurate systems control…

Large-Scale Freezing of Biologics

Production of biologics is an expensive process, and to optimize capacity use, bulk protein solution is often produced in manufacturing campaigns. It is converted into drug product based on market demand and therefore may have to be stored for relatively long periods. To decouple the bulk solution production from that of the final drug product, bulk is often stored frozen. Transport of frozen bulk product between sites offers several practical advantages over its transport in the liquid state (2–8 °C).…

Applying Intelligent Flow Microscopy to Biotechnology

Ongoing requirements for additional insight and CGMP-compliant measurement have led to interest in new technologies that can be applied to the analysis of many different types of particle-containing fluids. Micro-Flow imaging (MFI) is a robust, versatile, and intelligent vision technology that is increasingly used for evaluating populations of microparticles encountered during bioformulation development (1). It is also being accepted in fill–finish processes and many other biotechnology applications. Features of MFI technology that have contributed to its rising popularity include the…