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On the cutting edge
October 2018
by Mel J. Yeates  |  Email the author
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Analysis from Olympus and automation from Lonza. X-ray instrumentation from Rigaku and chromatography media for process protein purification from Bio-Rad. Plus next-generation process technologies from MilliporeSigma. That is what awaits you this month in our October roundup of tools you use in pharma and biotech.
 
Olympus introduces NoviSight 3D cell analysis software
WALTHAM, Mass.—Olympus Corp. announced in September the U.S.-only launch of a new 3D cell analysis technology with the ability to accurately analyze 3D cell cultures down to the nuclei, improving the reliability and accuracy of the entire drug discovery process.
 
Using 3D cultured cell tissue known as spheroids and organoids, researchers can analyze the effects and toxicity of new drugs in a bioenvironment similar to that of a living human body. Olympus combined its 3D imaging technology with powerful algorithms and a new method to analyze the whole cell model in 3D. The result is Olympus’ new NoviSight software with True 3D cell analysis technology.
 
Used with Olympus’ confocal laser scanning microscopes, such as the FLUOVIEW FV3000 system, NoviSight 3D cell analysis software provides images of the cell cluster down to the nuclei. According to the company, the software’s True 3D technology uses multiple microplate images to provide accurate morphology data and the ability to quantitatively analyze the effect of medications, including growth suppression and cell survival rates. A range of parameters can be easily and precisely measured, enabling researchers to count the number of cells that have suppressed growth, proliferated or been annihilated. NoviSight 3D cell analysis software also makes it easy to compare the effects of different medications at various concentrations.
 
Pushing the boundaries in automation—first glimpses at PDA 2018
WALKERSVILLE, Md.—Lonza announced recently the introducion of its next-generation endotoxin automation solution, PyroTec Pro Robotic Solution, at the Parenteral Drug Association (PDA) Global Conference on Pharmaceutical Microbiology in mid-October in Bethesda, Md.
 
Attendees of the PDA saw Lonza’s PyroTec Pro Robotic Solution for endotoxin testing and talked directly to Lonza experts about the innovations in the new WinKQCL Software. A few of the highlighted features include: generating robotic scripts and adapting to changing sample dilution requirements; controlling the procedure from start to finish; and importing sample test work lists from a sample management system and exporting the results back out to the same system, preventing transcription errors and saving time over manually entering data.
 
During the PDA Endotoxins Workshop that followed the conference, Lonza presented a new poster demonstrating how automated endotoxin testing can reduce the potential for human error substantially, enhancing the accuracy, reliability and traceability of results. The presentation also showed how laboratories can maximize their return on investment through the time and cost savings provided by automated endotoxin testing technology.
 
Entitled “The Automation of Endotoxin Testing: Streamlining Your QC Testing with Automated Endotoxin Testing and Process Optimization,” the poster was presented by Robert Porzio, product manager at Lonza, who explained how Lonza’s WinKQCL Endotoxin Automation Software Module could revolutionize the way endotoxin testing is being performed, allowing for an overall enhancement of lab efficiency and productivity.
 
Rigaku showcases their latest at JASIS
TOKYO—X-ray scientific, analytical and industrial instrumentation manufacturer Rigaku Corp. recently presented its lines of X-ray analytical products at the 2018 Japan Analytical & Scientific Instruments Show (JASIS), held Sept. 5–9 at the Makuhari Messe International Exhibition Hall in Chiba City, Japan. Among the instruments was the new sixth-generation Rigaku MiniFlex benchtop XRD, a general purpose X-ray diffractometer that can perform qualitative and quantitative analysis of polycrystalline materials.
 
The Rigaku NANOPIX mini is reportedly the first benchtop small angle X-ray scattering (SAXS) system dedicated to the characterization of nanoparticles in both research and production environments. This compact instrument is said to offer enhanced angular resolution through its line-focus X-ray source and superior combination of high figure-of-merit optics. Nanoparticle size, size distribution and particle shape are the key pieces of information obtained from SAXS.
 
Also featured at the exhibition was the next-generation Rigaku SmartLab intelligent multipurpose X-ray diffractometer with SAXS and in-plane capabilities, featuring the brand new PhotonMax high-flux 9 kW rotating anode X-ray source coupled with a Rigaku HyPix-3000 high-energy-resolution 2D multidimensional semiconductor detector that supports 0D, 1D and 2D measurement modes.
 
Elemental analysis by energy dispersive X-ray fluorescence (EDXRF) offers non-destructive measurement of sodium through uranium. EDXRF analyzers include the Rigaku NEX DE premium high-performance benchtop direct excitation EDXRF elemental analyzer, developed for heavy industrial applications and engineered to maximize flexibility and ease of use.
 
The new Rigaku ResQ CQL 1064 nm handheld Raman analyzer also debuted at the conference. It is the newest addition to the portfolio of handheld spectroscopic analyzers from Rigaku, and is designed for chemical threat identification. The unit’s improved ergonomics, analytical performance and sample presentation reportedly enable easier performance of chemical analysis of powders, liquids, gels and mixtures.
 
Bio-Rad launches CHT Ceramic Hydroxyapatite XT Media and Nuvia HP-Q Resin
HERCULES, Calif.—Bio-Rad Laboratories launched in late August two chromatography media for process protein purification: CHT Ceramic Hydroxyapatite XT Media and Nuvia HP-Q Resin. CHT Ceramic Hydroxyapatite XT (CHT XT) Mixed-Mode Media was formulated in response to customers’ need for a robust and stable resin that can maintain the superior performance of CHT resins.
 
CHT XT offers high resolution and efficient single-step clearance of aggregates and other impurities such as HCP, dsDNA, endotoxins and leached Protein A. It can be used in applications, such as purification of enzymes, monoclonal and polyclonal antibodies of various classes, antibody fragments and bispecific antibodies; efficient isolation and purification of viruses and virus-like particles (VLPs); and separation of supercoiled DNA from linear duplexes, as well as single-stranded from double-stranded DNA.
 
The key benefits of CHT XT Media include: unique selectivity (binds by cation exchange and affinity interactions, unlike any unimodal resin); reusability (improves economy of the process purification workflow); single-step clearance of aggregates and other impurities; and broad chemical compatibility with a wide range of chemicals.
 
Nuvia HP-Q Anion Exchange Resin was introduced to fill customers’ need for a high-performance resin compatible with high-throughput (HTP) large biomolecule purification. It can be used for downstream purification of large molecules such as high molecular weight (HMW) plasma proteins IgA and IgM, viruses, VLPs and PEGylated proteins.
 
Key benefits of Nuvia HP-Q Resin include: time efficiency and HTP compatibility—high flow rate compatibility (300 cm/hr) and fast mass transfer kinetics ensure purifications can be performed in less time; cost efficiency—lifetime of more than 100 cycles without loss of dynamic binding capacity (DBC) allows repeated use; mechanical stability—resin column holds up under the flow rates required for manufacturing-scale purification; and excellent DBC (>50 mg/ml) with optimized pore structure, spacer length and ligand density to improve productivity.
 
MilliporeSigma launches next-gen process technologies
BURLINGTON, Mass.—MilliporeSigma has launched three new products to help biomanufacturers navigate the evolving biopharma landscape with increased speed, greater flexibility and enhanced quality. These next-generation process intensification technologies were unveiled at the 2018 BioProcess International Conference & Exhibition in Boston. The company estimates that next-generation processing will reduce production costs by 25 percent or more, and free up manufacturing capacity by as much as 65 percent.
 
The technologies in question are the Eshmuno CP-FT resin, a reportedly first-of-its kind CEX chromatography resin for the flow-through removal of aggregates from mAb therapeutics, and two modified amino acids to simplify feeding and reduce total volume in cell culture: Phospho-L-Tyrosine Disodium Salt EMPROVE EXPERT, and L-Cysteine S-Sulfate Sodium Sesquihydrate EMPROVE EXPERT.
 
The Eshmuno CP-FT CEX chromatography resin uses flow-through frontal chromatography to remove aggregates from mAb therapeutics, which can induce an immunogenic response in patients. By enabling loading capacities 10 times higher than traditional bind/elute CEX chromatography, Eshmuno CP-FT resin reduces costs and improves productivity. It requires less resin and less buffer volume, while offering a shorter processing time.
 
Phospho-L-Tyrosine Disodium Salt EMPROVE EXPERT and L-Cysteine S-Sulfate Sodium Sesquihydrate EMPROVE EXPERT enable high concentrations of tyrosine and cysteine in cell culture feeds. They can be integrated into the main bioprocessing feed, simplifying fed-batch process with optimized productivity and reduced risk. The only such products that meet industry quality and GMP (per IPEC) standards, according to the company, these amino acids derivatives are stable and soluble at neutral pH and room temperature.
 
Code: E101829

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