Posters

Expansion of T-cells using the Xuri Cell Expansion System W25 and WAVE Bioreactor 2/10 System

Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated therapies is to target specificity with a consequent reduction in off-therapeutic effects. Immunotherapeutic products can be classified broadly into (1) active immunotherapy (therapeutic vaccines), (2) adoptive cellular immunotherapy (transfer of immune cells, genetically modified T-cells or precursor cells) or (3) passive immunotherapy (antibody or receptor ligand administration). Recent scientific advances have led to clinical trials of both active and…

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,…

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…

Cookie Cutter Proteolysis: Achieving Reproducible, Efficient Digestions for Proteomic Workflows

Cookie Cutter Proteolysis: Achieving Reproducible, Efficient Digestions for Proteomic Workflows   Protein sample preparation workflows for mass spectrometric analysis that involve proteolysis are often labor-intensive, time consuming and user dependent. These workflows often involve digestion, solid phase extraction, drying, and re-suspension prior to reversed phase separation into the mass spectrometer. The introduction of variability at many of these steps hinders discovery initiatives as well as the ability to convert these discoveries into viable assays.   Recently, an automated protein digestion…