Figure 1: ()   The production of therapeutic proteins like monoclonal antibodies (MAbs) and bispecifics depends on mammalian expression due to the posttranslational modifications occurring in these molecules. At Boehringer-Ingelheims (BIs) BioXcellence unit, we use the BI-HEX™ mammalian expression platform for fast and cost-efficient development of high-titered manufacturing processes. The BI-HEX™ platform is composed of the following interlinked elements: BI’s proprietary vector system, the BI-HEX™ cell lines, which are derived from the CHO-DG44 cell line (1), a short…

      EMD Millipore has developed a family of single-use bioprocess containers designed for mammalian cell growth and recombinant protein production. The Mobius® CellReady product offering includes bench-scale (3-L), small-scale (50-L) and pilot-scale (200-L) bioreactors spanning early process development through clinical batch production. To enable the successful scale-up of a biomanufacturing process, a number of factors critical to efficient cell growth, viability, and protein production were considered and used to develop an optimized design. These include mixing efficiency, gas…

    Figure 1: ()   Antibody fragments (e.g., Fab, scFv, DAb, etc.) are set to become the next important class of protein-based biotherapeutics after monoclonal antibodies (MAbs). One of the advantages is that due to their structure and smaller size, antibody fragments possess unique properties (e.g., easier tissue penetration) that suit a range of diagnostic and therapeutic applications. The industry standard for purifying MAbs is a platform approach using affinity chromatography with protein A as the capture step. The…

      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 for each bioreactor type to maximize product yields.…

One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells. The Escherichia coli pAVEway™ expression system described here has been developed to ensure high product titers and efficient scale up to GMP manufacture while minimizing many common issues seen in other expression systems, such as “leaky” expression (expression of recombinant protein in the absence of inducer). How It Works The use of a number of powerful E. coli…

    Figure 1: ()   Continously new bioprocesses are evolving, and bioprocessors are searching for the easiest way to process samples in R&D. Currently, a huge trend toward disposable production systems is notable. For these purposes plastic bags, stirred tank reactors, and storage tanks established on the market. Unfortunately, these reactor types are not suitable to perform sophisticated bioprocess development. In bioprocess R&D, throughputs of 50 to 1,000 fermentations are needed. Therefore, m2p-labs developed intelligent new tools at microscale…

      We have previously reported rapid, consistent, and highly productive fed-batch processes from shake flasks to 5-L glass and 200-L single-use bioreactors using the ActiCHO Media System (1). This system has demonstrated to be highly reliable in many processes using different Chinese hamster ovary (CHO) cell clones. PAA Laboratories/GE Healthcare manufactures this medium in both liquid and powder formats and supplies it worldwide for large-scale applications. Here we present some data on industrial scale-up studies going directly from…

      Microbial contamination of cell cultures is a major process risk that leads to lost production batches with considerable economic impact for a biopharmaceutical manufacturer. Incidences of penetration of typical 0.2-µm sterilizing-grade membranes by mycoplasma species have led to higher-retention 0.1-µm–rated filters becoming commonplace for filtering mammalian cell culture media.   Increasing Retention without Slowing Down Processing   There are a number of 0.1-µm–rated filters available, and although many are effective at removing mycoplasma contamination, the tighter filtration…

    Figure 1: ()   The Pfēnex Expression Technology™ platform is a very powerful protein expression technology based on the microorganism, Pseudomonas fluorescens. The Pfenex platform can deliver a robust production strain with unprecedented speed and a success rate that transcends legacy production hosts. Traditional recombinant protein expression hosts such as E. coli, insect cells, and yeast tend to have high failure rates regarding their ability to produce high titers of soluble, full-length, active target protein. In addition, the…

      SciLog’s MabTec™ is an add-on bioreactor maintenance system that can gravimetrically manage, automate, and document your bioreactor feeding or perfusion strategy. The MabTec™ upgrades many manual processes to walk-away automation with minimal investment in terms of capital or time.   Summary   MabTec™ combines accuracy with convenience to provide an ideal solution for cell culture feeding strategies. Based on the results, MabTec™ demonstrated the ability to increase protein production while eliminating several hours of manual daily operation.…