Pharmaceutical Technology Editors

Roche recently announced the launch of its first digital polymerase chain reaction (PCR) system, the Digital LightCycler System (DLS). The DLS is designed to detect disease and accurately quantify trace amounts of specific DNA and RNA targets that are not typically detectable by conventional PCR methods.

According to an Aug. 23, 2022 press release, the DLS will allow clinical research to divide DNA and RNA from a clinical sample into up to 100,000 microscopic individual reactions. This provides opportunities for high precision analysis, including identifying ultra-rare targets or accurately quantifying how much of the target DNA/RNA there is at a molecular level.

"Understanding the hidden characteristics of serious diseases is fundamental for ensuring that the most effective treatment is selected for each patient," said Thomas Schinecker, CEO, Roche Diagnostics, in the press release. “The Digital LightCycler System will support clinical researchers and laboratories in identifying rare and emerging disease mutations. This can be instrumental in early diagnosis and therapy decisions."

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Roche’s Digital LightCycler System is designed to aid in diagnostics for cancer, genetic disease, and infection.

Roche Launches Digital PCR System

The ROSS Vertical Blender is designed for reliable, gentle mixing of friable solids, abrasive materials, and shear-sensitive products. It consists of a low-speed auger that orbits the periphery of a conical vessel while gently lifting material upward. This agitation is intended to allow product from top portions of the batch to cascade to the bottom while blending with the material being drawn upwards by the auger. 

The Vertical Blender is angled steeply to allow for efficient blending of batches as small as 10% of maximum working capacity while also enabling the quick discharge of the finished blend. It does not require bearing or packing glands in the product zone and is designed to promote 100% discharge. In addition to solid blends, the product can mix wet applications, such as flowable slurries and pastes. The machine can be jacketed for heating or cooling with water, oil, or steam.

The ROSS Vertical Blender enables mixing of friable solids.

Versatile Low Shear Blending and Drying

Shimadzu’s Nexera XS inert is a bioinert and biocompatible ultra-high performance liquid chromatography that is designed to prevent the adsorption of target molecules to metal surfaces and mobile-phase corrosion caused by high salt content and extreme pH conditions. 

The system utilizes a metalfree sample flow path, which prevents unwanted interaction with biopolymers that are prone to adsorption onto exposed metal sites, resulting in reduced sample loss and excellent peak shape in data results. Additionally, all wetted surfaces of the system use corrosionresistant materials, which are designed to promote stability against mobile-phase solvents that contain high concentrations of salts or acids. This makes it well-suited for analyzing biopharmaceutical molecules, such as antibodies, peptides, and nucleic acid drugs. 

The system uses a stainless-steel-casing-reinforced polyether ether ketone tubing to promote mechanical and chemical resistance. It is designed for a pressure tolerance of >100 MPa while maintaining a bioinert flow path. An optional pHM-40 offers realtime measurement of the mobile-phase pH during an experiment.

Shimadzu’s Nexera XS inert is designed to prevent both adsorption of target molecules to metal surfaces and mobile-phase corrosion.

Adsorption-Free UHPLC

Cellefill, from Flexicon Liquid Filling, part of Watson-Marlow Fluid Technology Solutions, is a turnkey, vial fill/finish system that is designed to promote flexibility via an integrated barrier solution. It comes in three models with different barrier technologies that are designed to suit various filing requirements and class cleanrooms, each of which features peristaltic pump performance, an integrated barrier, and environmental monitoring. 

The technology uses Flexicon’s FPC60 aseptic vial filling machine and barrier technologies from Franz Ziel GmbH to enable end-to-end aseptic manufacturing of advanced therapy medicinal products. It also has aseptic single-use systems, pre-sterilized ready-to-use product containers, and a no-touch transfer debagging system.

Cellefill is a vial fill/finish system that designed to promote flexibility via an integrated barrier solutions.

Barrier Integrated Vial Fill/Finish System

Qosina’s AseptiQuik STC Series combines the company’s G, S, or C sterile connector with a Steam-Thru connection to enable flexibility between hybrid stainless steel and single-use processing equipment. This enables a genderless design that simplifies system integration at the aseptic connector end. 

The STC series is recommended for gamma and autoclave sterilization methods. The product is composed of polycarbonate and silicone materials and is offered in both standard and hightemperature variations. Additionally, it can be mounted directly to stainless steel processing equipment via a sanitary termination. 

Qosina’s AseptiQuik STC Series enables flexibility between hybrid stainless steel and single-use processing equipment.

Genderless Sterile Connectors

Lonza announced on August 22, 2022 that it has expanded the range of particle engineering services offered by its Monteggio, Switzerland site through the introduction of X-ray powder diffraction (XRPD). This analytical technique is designed to provide additional information about the polymorph and solid-state properties of active pharmaceutical ingredients (APIs).

The XRPD instrument began operations in Q2 2022. The new capability expands Lonza’s micronization portfolio and will allow the company to control the particle size of APIs and enhance their processing, bioavailability, and dissolution rates. According to a company press release, the Monteggio team will be investigating the solid state of crystalline materials and generate critical data across drug discovery, development, and manufacturing.

“The implementation of XRPD provides additional analytical information, highlighting differences in the solid state of materials before and after micronization, and determining whether additional processing is needed,” said Salvatore Mercuri, associate director new product introduction and MSAT, Lonza Monteggio, in the press release. “The XRPD improves our ability to detect solid state changes induced by the micronization process early in development and allows the problem to be properly addressed before the process is defined. This will ensure that our processes continue to obtain stable products suitable for further processing and formulation.”

Lonza has introduced X-ray powder diffraction capability at its Monteggio, Switzerland site.