Posters

Microbial Cultivation In Different Scales in the CELL-tainer® Rocking Single-use Bioreactor

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)…

A Systematic Strategy of Cell Culture Media and Feed Development

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…

Next Generation Depth Filters for the Clarification of Flocculated Mammalian Cell Culture

Increasingly high cell density, high product titer cell cultures, containing mammalian cells are placing a larger burden on traditional downstream clarification and purification operations due to higher product and impurity levels. EMD Millipore has addressed these challenges by developing a proprietary single-use technology to improve primary and secondary direct depth filtration of flocculated high cell density mammalian cell cultures. The use of graded depth filters, combined with pre-treatment technologies, have achieved higher primary throughput capacities and lower flushing volumes as…

Liquid-Liquid Porometry of Viresolve® Pro Membrane

A liquid-liquid porometry (LLP) test was developed to characterize the pore size distribution of Viresolve® Pro membrane. Data generated by this test supports the understanding of the size-based virus removal mechanism of the filter. The LLP test also is used at-line during membrane casting. Process control based on LLP results improves membrane consistency.

Semi-automated, Single-use TFF Systems With an ‘Open Architecture’ Design Maximize Flexibility and Allow Supply Chain Security

Cross flow filtration used in bioprocesses is typically either microfiltration to clarify process streams or ultrafiltration to concentrate and diafilter the biopharmaceutical molecule. Single-use cross flow operations provide a number of advantages over traditional stainless steel systems. These include: • Flexibility during process development • Reduced capital investment • Avoidance of cross contamination and faster product change overs • Elimination of steaming and cleaning utilities Parker domnick hunter’s innovative SciFlex® TFF system utilizes propriety technology allowing the sterile processing of…

Sartobind® pico and Sartobind® nano on Akta® – Optimizing Conditions for Liquid Chromatography Systems

Sartobind pico and Sartobind nano are the laboratory-scale mem-bers of the Sartobind membrane adsorber family. Accordingly, their small size and high throughput make them perfect for use on automated chromatography systems such as the popular Akta series offered by GE Healthcare Life Sciences.While both the pico and nano capsules are designed for high flow rates, the array of valves, pumps, monitors and the flow restrictor found in a typical flow path for gel chromatography can cause unacceptable pressures at the…

Continuous Bioprocessing: A CMO’s Perspective

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…

Scalable Method for Packing Chromatography Columns

Currently the bio-pharmaceutical industry is heading towards cost cutting, time saving and single use manufacturing approach. This has opened up a whole new market for disposable technologies. Pre-packed disposable chromatography columns are a best fit for preclinical and clinical stage Monoclonal Antibody (mAb) production and vaccine manufacturing processes which require quick turnaround times and aggressive validation respectively. This work describes development of pre-packed and ready to use chromatography columns to meet this need in the industry. A robust packing method…

Viral Vector Production in the Integrity® iCELLis® Disposable Fixed-bed Bioreactor from Bench-scale to Industrial Scale

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…

Is the Gold Standard Tarnished? Weaknesses in the Standard Method Compromise Your RMM Validation

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…