Development of a high-performance and robust fed-batch process for recombinant Chinese Hamster Ovary (CHO) cell lines presents challenges in light of the diverse nutritional requirements observed with different clonally derived cell lines as well as the varied production phases. To address these challenges, we will discuss an innovative strategy of media, feed, and process development that has been developed at FUJIFILM Diosynth Biotechnologies (FDB). The efficiency and effectiveness of this strategy have been well demonstrated in multiple mAb-producing CHO cell…

Single-use bioreactors are applied in the biopharmaceutical industry for mammalian cell culture processes. The low gas-liquid mass transfer coefficient generally achieved in these systems does not allow for the compatable application of microbial processes in these bioreactor systems. The CELL-tainer® technology combines a vertical and horizontal movement in a rocking bioreactor concept, so that the turbulence and power input is intensified. In this system, mass transfer rates comparable to stirred tank reactors are achievable. Thus, volumetric oxygen transfer rates (kLa)…

Pseudomonas fluorescens, a Gram-negative bacterium, has been specifically developed as a protein production platform to enable rapid identification of strains capable of expressing high titers of soluble and active protein. Pfēnex Expression Technology (TM) employs a toolbox of engineered P. fluorescens host strains, including protease deficient mutants and chaperone/ foldase overexpressors combined with a set of expression vectors encoding a variety of transcription and translation regulators, as well as a collection of periplasmic secretion signals. High-throughput automated transformation, growth, and…

The maturation of many process industries is marked by transition from batch to continuous processing. Often this move to con-tinuous processing determines the winners in the industry. Will the bioprocess industry go the same way? The analogy is often drawn to the chemical industry where continuous processing is widely applied. Although available for many decades continuous bioprocessing is not yet a mainstay of the industry. Currently there is a ground swell of feeling within the bioprocess industry that the time…

Recombinant viruses (e.g. lentivirus and adeno-associated-virus) can be used as human gene therapy vectors. They are mainly produced in adherent cell cultures (e.g. HEK293T, A549, VERO) in Roller Bottles or multiple-tray-stacks using either transient transfection or infection strategies. Therefore, the Integrity® iCELLis® (ATMI LifeSciences) line of bioreactors offers a new production alternative with stronger process controls and ease of scale-up.   The iCELLis bioreactor is designed for adherent cell culture applications. Cells grow on microfibers carriers packed in a fixed-bed…

Introduction of a new Rapid Microbial Method (RMM) requires a full validation. The purpose of the validation is to prove that equivalent or better results are obtained using the new method when compared to the compendia. One assumes that the result obtained with the compendial method is absolute and is the “Gold Standard” by which to compare the new test. In reality, the compendial method exhibits a number of weaknesses that compromise the integrity of the validation. The standard requires…