Pharmaceutical Technology Editors

The Dynatrol G Series Level Switches are intended for special problem applications involving very light or fluffy products or for heavier bulks solids that pack or bridge easily. Designed for accuracy on high, intermediate, or low-point level detection, the switches are built to work in dusty environments, while specialized units can be used in temperatures exceeding 300°F.

The Type GJ switch is designed for pharmaceutical powders, powder materials for coating beads and tablets, fillers, and other substances that vary widely in bulk density or particle size. The Type GS and GSS switches are also intended for fine powders while working with beads as light as polystyrene, for example, as well.

Automation Products Inc., Dynatrol Division

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The Dynatrol G Series Level Switches are designed to accurately measure light or heavier bulk solids for problem applications. 

Accurate Level Switches

DuPont celebrated the opening of its DuPont Liveo Healthcare Solutions manufacturing facility on July 28, 2022. The new facility, located near Moncks Corner, SC, will expand the company’s capacity for biopharmaceutical tubing extrusion.

“The [site] will bring additional production capacity online over the next two years to serve strategic customers and expand our Liveo Healthcare Solutions customer base,” said Eugenio Toccalino, global business director, healthcare and specialty lubricants, DuPont, in a company press release. “We’re committed to investing in our healthcare business, and this biopharma processing manufacturing investment is a key milestone in our growth strategy that will help us offer a highly reliable and sustainable product supply.”

In addition to this expansion, the company also expects to add biopharma silicone tubing capacity in China in the second half of 2022.

DuPont’s new manufacturing site will expand its biopharmaceutical tubing manufacturing capabilities.

DuPont Opens Biopharma Tubing Manufacturing Site in South Carolina

Moderna announced that the United States government has agreed to purchase 66 million doses of the company’s COVID-19 vaccine booster candidate, mRNA-1273.222, for $1.74 billion on July 29, 2022. The bivalent candidate contains the Spikvax vaccine as well as the omicron BA.4/5 strain mRNA.

According to a company press release, $1.74 billion will be awarded to Moderna following the manufacture and delivery of 66 million doses of the vaccine. The agreement includes an option for the US to purchase up to an additional 234 million doses of the COVID-19 vaccine booster.

"We are pleased to extend our successful collaboration with the [US] government," said Stéphane Bancel, CEO, Moderna, in the press release. "Moderna's mRNA platform is enabling us to rapidly create mRNA-1273.222, a bivalent vaccine that specifically targets [omicron] subvariants BA.4 and BA.5, the most prevalent variants of concern in the [US] today. We remain fully committed to leveraging our innovative technology platform to offer tailored vaccines that help protect communities against COVID-19."

In addition to mRNA-1273.222, Moderna is also developing mRNA-1273.214. This contains the BA.1 omicron strain, which WHO noted may be of benefit to the public.

The United States has agreed to purchase 66 million doses of Moderna’s bivalent COVID-19 booster candidate for $1.74 billion.

The US Purchases 66 Million Doses of Moderna’s COVID-19 Vaccine for $1.74 Billion

AbbVie announced that the European Commission approved Rinvoq (upadacitinib) for treatment of active non-radiographic axial spondyloarthritis (axSpA) on July 29, 2022. It is approved for adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or magnetic resonance imaging, who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

AxSpA is a chronic, progressive, and disabling inflammatory rheumatic disease that causes joint inflammation. There are two subsets: radiographic (r-axSpA) and non-radiographic (nr-axSpA); according to an AbbVie press release, approximately 10-40 percent of patients eventually progress from nr-axSpA to r-axSpA over a 2-to-10-year period.

Upadacitinib is a selective janus kinase (JAK) inhibitor that is being evaluated for various immune-mediated inflammatory diseases. In human cellular assays, it preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.

"For years, healthcare providers and patients have had limited treatment options to manage axial spondyloarthritis, which can cause back pain, stiffness, and irreversible damage to the spine," said Thomas Hudson, chief scientific officer and senior vice-president of Research and Development, AbbVie, in the press release. "AbbVie is proud to offer [upadacitinib] as a first-in-class treatment option now approved in the European Union for adults living with nr-axSpA with objective signs of inflammation and inadequate response to NSAIDs. {Upadacitinib] is the first and only JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis, which includes nr-axSpA and ankylosing spondylitis."

The European Commission has approved Rinvoq (upadacitinib) for treatment of active non-radiographic axial spondyloarthritis.

European Commission Approves AbbVie Axial Spondyloarthritis Treatment

PTC Therapeutics, a global biopharmaceutical company, announced on July 20, 2022 that it had been granted a marketing authorization for Upstaza (eladocagene exuparvovec) by the European Commission for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency in patients aged 18 months and older. According to a company press release, Eladocagene exuparvovec is the first approved disease-modifying treatment for AADC deficiency as well as the first marketed gene therapy that is directly infused into the brain.

AADC is a rare, fatal genetic disorder that typically results in severe disability from the first months of life. Eladocagene exuparvovec is a one-time, recombinant adeno-associated virus serotype 2-based gene replacement therapy that contains the human DDC gene. It is designed to correct the underlying genetic defect of AADC by delivering a functioning DDC gene into the putamen, increasing the AADC enzyme and restoring dopamine production.

"Today's approval from the European Commission for Upstaza for the treatment of AADC deficiency is momentous for patients, for PTC, as well as for the larger gene therapy community," said Stuart W. Peltz, CEO, PTC Therapeutics, in the press release. "We are proud to bring this innovative therapy to the marketplace so that patients may benefit [and] are ready to deliver this long-awaited treatment to patients as soon as possible."

The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

PTC Granted Marketing Authorization by European Commission for AADC Deficiency Treatment

Shimadzu launched its new Nexera XS inert, a bioinert and biocompatible ultra-high performance liquid chromatograph (UHPLC), in July 2022. The system is designed to resolve the most common problems in biopharmaceutical analysis, such as the adsorption of target molecules to metal surfaces and mobile-phase corrosion caused by high salt content and extreme pH conditions.

The Nexera XS inert UHPLC resulted from cooperative research done with Yasushi Ishihama, a professor at the Graduate School of Pharmaceutical Sciences at Kyoto University in Japan under the Japan Science and Technology Agency’s Adaptable and Seamless Technology Transfer Program through Target-driven R&D (A-STEP) project from 2017 to 2020. The system features a metal-free sample flow path, which prevents unwanted interaction with biopolymers that are prone to adsorption onto exposed metal sites. Through this mechanism, the Nexera XS inert results in reduced sample loss and excellent peak shape for generating reproducible, high-sensitivity and high-quality reliable data, according to a July 19, 2022 company press release.

Furthermore, all wetted surfaces have been prepared from corrosion-resistant materials, which renders them stable against mobile-phase solvents that contain high concentrations of salts or acids. Nexera XS inert is particularly well-suited for analyzing biopharmaceutical molecules, such as antibodies, peptides, and nucleic acid drugs.

The new system offers the same analytical intelligence features as the other products in the Nexera series as well as the following features:

Unconstrained recovery and sensitivity: in the quantitative analysis of biomolecules, adsorption of the target compound to a metal surface can result in a dramatic decrease in sensitivity. The Nexera XS inert system comprises stainless-steel-casing-reinforced polyether ether ketone (PEEK) tubing, which is a high-performance engineered polymer with mechanical- and chemical-resistance properties. This ensures a system pressure tolerance of > 100 MPa while maintaining a bioinert flow path. The system also includes a ceramic injection needle, which offers metal-free injections and minimized carryover. By preventing adsorption to metal surfaces, the Nexera XS inert system thus achieves much higher sensitivity and better reproducibility than a general-purpose UHPLC system.

Assured reliability and reproducibility: high salt conditions in the mobile phase can result in the corrosion of stainless-steel parts in standard UHPLC systems, but, in the Nexera XS inert system, the wetted surfaces are prepared from highly rust-resistant materials, while still maintaining the high-efficiency flow-path (i.e., 105 MPa). Because of this design, the system remains unaffected by high salt content, ion pairing agents, or extreme pH conditions, ensuring long-term stability and reliable data acquisition.

Clear resolution without restrictions: the system’s ability to resist 105 MPa of pressure means it can use long separation columns packed with small-sized particles, which allows it to achieve ultra-high efficiency in a wide variety of applications. The newly developed PEEK-lined tubing comes with tool-free, finger-tightened fittings, allowing for reliable connections between columns, which enables the system to withstand a pressure of up to 105 MPa without creating any dead volume or risking damage by overtightening. All valves used in the Nexera XS inert system have been designed to inhibit metal adsorption for worry-free switching between multiple columns. This characteristic is useful for method development or for trap-and-elute analysis. An optional pHM-40 offers real-time measurement of the mobile-phase pH during the course of an experiment. This ensures accuracy and traceability, even when running a pH gradient, as used in ion exchange chromatography.

Consumables ideal for analyzing biopharmaceuticals: analyzing biomolecules, such as proteins, peptides and nucleic acids, requires columns with different separation modes. For some samples that are sensitive to metal ions, metal adsorption must be taken into consideration, and an optimal column would address this issue. The columns used in this new system (Shim-pack series of columns) is fitting for the analysis of a wide variety of biomolecules. In addition, adsorption of target analytes in the sample vial can greatly affect the analysis and requires special attention. Furthermore, a low-adsorption polypropylene vial (TORAST-H Bio Vial, Shimadzu) is also most fitting for peptide drug research, while low-adsorption glass vials (TORAST-H, Shimadzu) are suitable for general-purpose analysis.

Shimadzu’s new ultra-high performance liquid chromatography system is designed to solve common problems in biopharma analysis.