Posters

The Importance of Thresholding in Imaging Analysis of Protein Aggregates

Dynamic imaging particle analysis (DIPA) shows much greater sensitivity to transparent particles, such as protein aggregates, than light obscuration can. While not yet fully accepted in industry compendia, DIPA is being used increasingly in the formulation process for characterization of sub-visible particulates in biologics. DIPA measures particle size and shape by first creating a binary image based upon a defined threshold from the background value for each pixel in the image. The resulting binary image is used for all particle…

Platform Purification of a Domain Antibody

Monoclonal antibodies (MAbs) are very successful for treatment of several different cancers and tumors. However, the low tissue penetration has led to the development of smaller sized biopharmaceuticals (Ab fragments) such as Fabs, single chain Fv (scFv) and domain antibodies (Dabs). These molecules lack the Fc part of the antibody making a platform purification approach using Protein A impossible. However, with the introduction of the Protein L based affinity chromatography media (Capto™ L) new possibilities are introduced for capture of…

Aggregate Removal from Monoclonal Antibody with Nuvia™ HR-S Media

Nuvia HR-S media is a new cation exchanger designed for high resolution of closely related product impurities such as aggregates. It delivers excellent resolution, with a final aggregate content of <0.3%, and high recovery of >80% from a heterogeneous feed of monoclonal antibody aggregates and monomer. Aggregate content and recovery in the eluate were shown to be functions of the target conductivity measured at the end of collection.

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…