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PTSM: Pharmaceutical Technology Sourcing and Management
A sampling of new laboratory equipment showcases streamlined operations.
A survey, conducted by Agilent Technologies, indicated that downtime reduction and complexities of instrument testing requirements, among other things, are key concerns for lab operations managers. In an increasingly competitive market, equipment suppliers are working to address many of these concerns by releasing an assortment of new products intended to compete with pre-existing technologies. The following is a sampling of these new laboratory equipment options.
The Amersham Typhoon NIR Plus Biomolecular Imager from GE Healthcare Life Sciences includes a three-laser flexible configuration (1). The imager provides two essential near infrared (NIR) channels, as well as a third visible laser channel for triplex protein detection, to facility normalization and the reduction of blot-to-blot variation. The imager is suitable for multiuser environments. It features sensitive detection, high image resolution, and a linear dynamic range with multi-fluorescent, and stained samples. The imager can scan up to nine microtiter plates simultaneously, and is also suitable for high throughput screening.
The NIR Plus’s open-format data files enable direct analysis with commonly used image analysis software. The imager accommodates a range of diverse samples with high (10 µm) resolution, a dynamic range of greater than five orders of magnitude, and high sensitivity of as low as 3 pg, including tissue sections, plant leaves, and cell colonies in addition to traditional gels, membranes, multi-well plates, and dishes.
The new Thermo Scientific ISQ EC Single Quadrupole mass spectrometer (MS) integrates with an existing ion chromatography (IC) or high-performance liquid chromatography (HPLC) system and provides small-molecule sensitivity and mass confirmation (2). The Chromeleon Chromatography Data Software platform has embedded ISQ EC MS instrument control, which enables users to minimize time spent on new MS user training. The instrument also enables users to analyze a range of simple and complex sample matrices.
The new range of Thermo Scientific MAbPac RP 1-mm columns are designed for high-performance, reversed-phase chromatography characterization of monoclonal antibodies, fragments, variants, antibody drug conjugates, and proteins. With a 1-mm inner diameter, the new columns provide sensitive analyses of very small sample volumes at low flow rates for direct injection into the LC-MS. The columns include a polymeric resin with an optimized pore size and thermal and pH stability.
Agilent’s new InfinityLab LC purification solution provides a complete portfolio of analytical-scale to preparative-scale purification systems (3). Comprised of 11 modules plus accessories and software, the new solution enables laboratories to tailor purification systems to meet their needs. The 1260 Infinity II Prime LC has an extended pressure range (up to 800 bar), in addition to quaternary mixing and specifically designed columns. The automated instrument reduces the need for manual interaction, which increases efficiency. The Intelligent System Emulation Technology (ISET), initially only available with 1290 Infinity II LC systems, ensures method transfers from many Agilent and third-party legacy instruments. The company’s new 1260 Infinity II SFC system offers improved performance in supercritical fluid chromatography as well as a high separation speed.
The pilot fermenter from Bosch for the cultivation of APIs on laboratory and pilot scale can process batch sizes ranging from 8-50 liters (4). Reactor sizes for 100 and 200 liters are available for pilot and small industrial batches. The system can be equipped with one of several interchangeable mixing elements, designed for different cell types and process controls. The mixer regulates the inflow of liquids or gases needed for cell cultivation. Sensitive cells require the use of gentler technologies like the air lift module, while more robust cells can be stirred mechanically. Process media is fed automatically.
The pilot fermenter is equipped with a gentle rotary pump and a second reactor vessel supporting batch and fed-batch processes, as well as perfusion and continuous processing. In addition, the system is built as a package unit, and the integrated wall allows the clear separation of technical section from operational area. The fermenter is designed for easy cleaning and sterilization. Its integrated periphery includes a steam generator, exhaust air cooler, and a heating/cooling device for the bioreactor. Depending on the task-specific requirements, up to four interchangeable process sensors are available. This concept enables quick installation at available spaces with limited media availability and quick changeover.
The valveless fluid transfer pumps from Fluid Metering Inc (FMI) integrates CeramPump pumping technology with the long-life performance of a brushless DC motor and driver electronics (5). FMI’s CeramPump valveless piston fluid control technology utilizes one moving part, a rotating and reciprocating ceramic piston to accomplish all fluid control functions within the pump. The pumps also include sapphire-hard, dimensionally stable ceramic internal components.
The Reliance 980PG Pharmaceutical Grade Washer from STERIS is a pharmaceutical grade washing system (6). The rotation of the system’s spray arms can be monitored, ensuring coverage of all the items in the load is complete. The new Reliance 980PG system complies with the ASME BPE standard, which relates to the requirements applicable to system design for bioprocessing, pharmaceutical, and personal care product industries. The electronic data security options allow users to the system to manage vital electronic data and comply with FDA 21 Code of Federal Regulations Part 11 and European Annex 11 requirements.
1. GE Healthcare Life Sciences, “Flexible Amersham Typhoon NIR Plus Biomolecular Imager for Near-Infrared Multiplex Detection,” Press Release, May 16, 2017.
2. Thermo Fisher Scientific, “New Single Quadrupole Mass Spectrometer and Specialized Columns Designed to Deliver Reproducible and Robust Separations, Increased Analytical Accuracy,” Press Release, June 19, 2017.
3. Agilent Technologies, “Agilent Technologies Unveils New Analytical and Purification Solutions at HPLC 2017,” Press Release, June 19, 2017.
4. Bosch, “Bosch Launches a Pilot Fermenter for Manufacturing APIs,” Press Release, June 8, 2017.
5. Fluid Metering Inc, “New Valveless, Fluid Transfer Pump for Analytical Instrumentation,” Press Release, June 22, 2017.
6. STERIS Corporation, “STERIS Corporation Launches the Reliance 980PG Pharmaceutical Grade Washer,” Press Release, June 1, 2017.