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The article informs that LCGC, the leading resource for separation scientists, has bestowed Ronald E. Majors and Zachary S. Breitbach as the winners of the 11th annual LCGC Lifetime Achievement and Emerging Leader in Chromatography Awards, respectively.

The article overviews the impacts on intensification of chromatography platforms in biopharmaceutical manufacturing firms. Particular focus is given into the aspects, benefits and the popularity on the use for COMPAC2T platform (Merck KGaA), a process for intensifying the purification train and chromatography. It also notes on the process analytical tools needed for implementation of product quality indicators.

Aggregated singletons for automated purification (ASAP) is a purification workf low that provides singleton sample purification, registration, and delivery to the materials management department as 30 mM dimethyl sulfoxide solutions for biological screening. The singleton samples submitted are aggregated in a mini-array of 10-12 samples and then are analyzed using an automated purification process. The steps in the process include pre-quality control (QC), preparative chromatography, solvent evaporation, reformat dilution and duplication, final QC, and final registration. The turnaround time from samples received to delivery to materials management is two or three business days. The final QC data are uploaded to a database and are available to chemists via electronic laboratory notebook software. The final purity, weight recovery, and registration information is available in a research database and an e-mail notification of completion is sent to the chemist. ASAP enables a high purification success rate, increases the likelihood of running mini-arrays that generate 5-10 analogs in a final step rather than one or two with the same 2-3 day turnaround time, and provides expert-level service and technology. [ABSTRACT FROM AUTHOR]

The article discusses the key process economic drivers and the impact of scale and titer on downstream processing economic trade-offs. As titers increase to 10-15g/L, it is expected that this will have a profound effect on reducing COG/g, as long as the purification costs do not negate the cell culture gains. Increasing the titer to satisfy larger market demand increases the protein load on chromatography steps resulting in an increase in the number of cycles or additional investment.

The article discusses the significance of incorporation of quality and economy for biopharmaceutical chromatographic purification processes. It is stated that the application of the concept of quality by design into downstream purification processes can expedite first-in-human clinical trials, product licensure and technology transfer. The downstream purification heuristics offers a strategy for economical development and licensure of high products.

Improved feedstream titres are driving a demand for increased downstream processing productivity as manufacturers seek to lower the costs of monoclonal antibodies (MAbs). The unique selectivity of protein A has enabled platform technologies for MAb purification. Platform technologies and chromatography resin improvements can help manufacturers achieve rapid and economical process development and scale-up. A multiprong approach can enable downstream process scientists to enhance productivity. [ABSTRACT FROM AUTHOR]

The article focuses on the significance of on-line high-performance liquid chromatography (HPLC) in measuring product purity in the column eluent stream in near-real time. On-line HPLC monitors the eluent from process-scale columns. It allows process decision based on critical quality rather than on a surrogate measurement. Its data enable the automation and control of a purification column operation. It is also used as a process analytical technology ensuring the accommodation of variability.

The article describes the multicolumn countercurrent solvent gradient purification (MCSGP) process, which has been built using commercial chromatographic equipment. MCSGP is a continuous chromatographic process for monoclonal antibodies without using Protein A. Its application for purifying a monoclonal antibody (MAb) from a clarified cell culture supernatant shows that the process can result in purities and yields like those of purification using Protein A.

The article focuses on the significance of improved downstream process design for the production of human monoclonal antibody. The new downstream purification processes could be attributed to low cost, long lasting and high binding cation exchange resins. The processes can be less validated and more operational through column chromatography replacement. Non-Protein A purification process offers cation exchange capture column followed by anion exchange flow-through membrane chromatography.

The article discusses the methodology for using amide hydrogen-deuterium exchange with chromatographic materials as a means to identify buffer and resin conditions that are destabilizing to specific proteins. It is found that amide hydrogen-deuterium exchange is a powerful tool for fast resin screening during purification process development.

Focuses on the introduction of large numbers of columns and packing materials designed for preparative liquid chromatography during the Pittcon conference in the U.S. Basics of preparative chromatography; Exploration of the use of column in preparative high performance liquid chromatography; Goal of a preparactive purification.

The article highlights the research on the effectiveness of XSelect Columns and Focused Gradients in isolating and purifying ranitidine in the U.S. The research shows that ranitidine has better retention under high percentage of Hydrogen (pH) mobile phase conditions using ammonium hydroxide. Moreover, the method can directly transfer chromatographic separations between the analytical and preparative column dimensions.

The article examines the benefits of utilizing flash or high performance liquid chromatography (HPLC) for compound purification. It discusses several factors to consider before starting a liquid chromatography purification of a target compound which includes difficulty of the separation, amount of compound needed and available instrumentation. It concludes that the purifications do not require high efficiency and added that flash is a viable alternative to HPLC for compound purification.

The article discusses a study on the flash purification of δ-tocopherol and high performance liquid chromatography (HPLC) analysis for sample purity. It defines HPLC as a method using small particle media, while flash purification as a technique using larger particle media. It discovers that chromatographic separations can be transferred between HPLC and flash purification and both methods save time and money.

The article focuses on the investigation of the routine switching between high and low pH on a single XBridge high performance liquid chromatography (HPLC) column. The ability to switch between pH extremes on a single HPLC column can reduce the time for separation of pharmaceutical compounds. After several cycles of exposure to high and low pH, no deterioration was seen which makes XBridge an ideal choice for the routine screening, method development and purification of pharmaceutical compounds.

The article features the Flash Chromatography, a popular method that separates organic compounds through purification. The technique is used to scale up normal phase chemistries from thin layer chromatography. It also extends a wide range of applications, which includes purification of small compounds, peptides, and purification of natural products.

Demonstrates the application of the cLC System from Gilson Inc. as a single chromatography system capable of automating the purification of compounds for reverse and normal phase preparations. Ability of the system to accommodate various detection modes; Automation of on-line evaluation of collected fractions through integration of analytical components into the system; Possibility of handling five columns.