Posters

Enhancing Efficiency and Economics in Process Development and Quality Control of Biotherapeutics

Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development, quality control and manufacturing of biotherapeutics. UV spectroscopy, ELISA and HPLC have been in use for decades for protein quantitation in physiological and process samples, and continue to be the workhorses despite their many limitations. Biopharmaceutical companies have enthusiastically adopted Pall ForteBio’s Octet® systems due to their high throughput capabilities, decreased sample preparation requirements, and low cost of operations. The Octet systems…

A Case Study: 3-step Process for Efficient mAb Purification

This study showcases a portfolio of commercially available biopharmaceutical chromatography resins designed for the efficient purification of monoclonal antibodies. A 3-step purification process has been implemented which showed effective removal of the main contaminants, low ligand leakage, and high yields over the entire process. Eshmuno® A affinity chromatography resin was evaluated as the first step in the process. The Protein A elution pool was further purified using cation exchange chromatography. Two cation exchange resins with different selectivities were compared. The…

Progress On A Fully Disposable Downstream Platform: A Simple, Risk-Free, Plug-in Solution To Solve The DSP Bottleneck

Natrix HD Membrane technology features a polymeric hydrogel formed within a flexible porous support matrix. The support matrix provides mechanical strength, while the hydrogel properties determine the separation chemistry of the product. An advantage of the Natrix chemistry is the ability to place virtually any functional group chemistry throughout the hydrogel polymer. Natrix HD membrane technology combines the superior binding capacity of conventional resinbased columns with the high throughput of membranes in a single-use format that eliminates costly packing, cleaning,…

Rapid Antigen Production in Pseudomonas fluorescens Utilizing a High-throughput, Parallel Processing Approach

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…

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…