Pharmaceutical Technology Editors

Thermo Scientific’s DNAPac RP HPLC columns | Image courtesy of Thermo Fisher Scientific.

The Thermo Scientific SurePac Bio 550 SEC MDi columns enable fast separations of adeno-associated virus (AAV) monomers and aggregates. The columns are designed with 3 µm monodisperse particles and inert (MDi) column hardware aimed at providing superior AAV monomer retention and higher resolution of aggregates in cell and gene therapies. These columns offer fast run times, optimal separation efficiency, and reliable results with the goal of accelerating time-to-market for novel therapeutics. In addition, Thermo’s DNAPac RP HPLC columns are offered in semi-preparative formats to enable scalability in the development of DNA/RNA oligonucleotides. The DNAPac RP semi-preparative columns are designed so that laboratories can navigate the expanding field of oligonucleotide therapies and precision medicine. The DNAPac RP semi-preparative column utilizes unique chemistry for enhanced performance across wide ranges of pH, temperature, and mobile-phase compositions, offering precise separations and sample purification.

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Thermo Scientific’s columns offer fast run times, optimal separation efficiency, and reliable results.

Separation and Purification Columns for Enhanced Retention

Freudenberg Medical’s Y-connector assemblies | Image courtesy of Freudenberg Medical.

Freudenberg Medical has added custom single-use assemblies to its product portfolio. The new offerings consist of, but are not limited to, single-use Y-connector manifolds, tubing assemblies, and bottle cap assemblies with multiple inlets/outlets. Bottlecap assemblies with Y-connector tubing are commonly used in labs and in current good manufacturing practice (CGMP) bioprocesses during critical fluid transfer applications. The single-use assemblies are cleanroom manufactured. The Y-connector overmolds offer unobstructed flow within a critical fluid path and can prevent leaks from occurring. Leaks are commonly seen with standard fluid couplings, fittings, and connectors. The expanded portfolio complements the company’s existing PharmaFocus Premium product line, which contains high purity, platinum-cured silicone tubing and sanitary ends for single-use systems. The company’s tubing, molded components, and systems are used in bioprocessing, biotechnology, lab processes, GMP manufacturing, and small batch processes as well as for the production of cell and gene therapies, messenger RNA, biosimilars, and regenerative proteins.

Freudenberg Medical’s new offerings include single-use Y-connector manifolds, tubing assemblies, and bottlecap assemblies, among others.

Custom Single-Use Assemblies

The ROSS CDA-300 Dual Shaft Mixer | Image courtesy of Charles Ross & Son Company.

The ROSS CDA-300 Dual Shaft Mixer includes two agitators: one is a two-wing anchor agitator that is driven by a 20 horsepower (HP) totally enclosed fan cooled (TEFC) high efficiency, inverter duty motor; the second agitator is a high-speed disperser that is powered by a 60 HP TEFC high efficiency, inverter duty motor. The mixer is designed with a disperser that has an open disc blade, capable of traveling roughly 5000 feet per minute to induce vigorous turbulent flow. This vigorous flow creates a vortex into which dry ingredients can be added for fast wetting. The change can on the CDA-300 features an air/oil hydraulic lift that allows the use of multiple mix cans constructed of stainless steel type 304. The mix cans include heating/cooling jackets on the sidewalls and bottom for temperature control. Easy discharge is enabled by a three-inch manually operated stainless-steel flush bottom ball valve with tri-clamp connection. The mixer can be easily moved around the production floor on casters. The mixer is designed for vacuum operation to produce air-free products with highly repeatable density, viscosity, composition, and dispersion quality. The NEMA 12 control panel includes a seven-inch color touch screen for user-friendly operation, while providing independent agitator speed controls, load display, cycle timer, and other functions as well as ensuring safety with limit switches that prevent operation in the absence of the mix can or when the agitators are not in the mixing position.

Charles Ross & Son Company has introduced the ROSS CDA-300 Dual Shaft Mixer, consisting of two agitators and a disperse with an open disc blade. 

Dual Shaft Mixer for High-Performance Applications

Asahi Kasei Medical’s virus removal filters | Image courtesy of Asahi Kasei Group

Asahi Kasei Medical’s Planova virus removal filters are used in the manufacturing processes of biopharmaceuticals and plasma derivatives. The filters are also used in biosafety testing services and biopharmaceutical contract development and manufacturing operations. Planova comprises cellulose hollow-fiber membrane filters that were developed to specifically remove viruses from biotherapeutic products. The line was launched in 1989 and was followed by Planova BioEX hydrophilic polyvinylidene fluoride hollow-fiber membrane filters in 2009. Both product lines have been adopted worldwide. The latest offering is Planova S20N, a next-generation line of cellulose hollow-fiber membrane filters, which was launched in 2022. This latest addition features robust virus removal capability and simplified operation.

Asahi Kasei Medical now offers its Planova virus removal filters for use in biopharma manufacturing and plasma derivatives manufacturing.

Virus Removal Filters

ROSS FDA-3500 dual shaft mixer | Image Credit: Charles Ross & Son Company

The ROSS line of Dual Shaft Mixers are robust, versatile systems with enough power to batch dispersions, suspensions, and emulsions with viscosities up to several hundred thousand centipoise. The custom-built ROSS FDA-3500 has a maximum working capacity of 3500 gallons, a two-zone stainless-steel dimpled jacket for heating/cooling, a 4-inch pneumatic discharge valve, and an explosion-proof load cell system rated for up to 20,000 lbs.

This multi-agitator system is equipped with independently controlled drives and is designed to efficiently produce good turnover and impart shear to a viscous batch. Powered by a 300 HP TEFC inverter duty motor, the high-speed disperser runs at tip speeds up to 5000 ft. per minute, inducing high shear forces. Meanwhile, the 60 HP Three-Wing Helical Anchor Agitator feeds product towards the disperser blade and ensures that the mixture is constantly in motion. Teflon scrapers on the anchor wipe materials from the vessel wall, enhancing heat transfer from the jacket.

The ROSS FDA-3500 dual shaft mixer is equipped with independently controlled drives and is designed to efficiently produce good turnover and impart shear to a viscous batch.

Dual Shaft Mixers with Multi-Agitator System

GEA Pharma & Healthcare has introduced NexGen Press 45, the latest member of its NexGen Press line of tablet presses. The larger NexGen Press 45 builds on the previous NexGen Press 30 version and offers the same benefits as the smaller generation, including flexibility to adapt to any containment level (up to occupational exposure band 5 [OEB5]), which is attributed to the FAST CHANGEOVER Exchangeable Compression Module (FCO ECM). The new press can also be equipped with the same option packs as the previous version, enabling agile production and making it a system that can be tailored to accommodate a wide range of tableting applications (e.g., multi-unit pellet system, bilayer, poorly flowing products, high yield, microtablets, etc.). Additionally, the system can accommodate different cleaning strategies (wash offline or inline). A further advantage of the NexGen Press range is that every machine is equipped with six compression modes and each benefits from GEA’s unique Air Compensator technology, which effectively reduces common compression issues.

The NexGen Press 45 is the latest member of GEA Pharma & Healthcare’s NexGen Press line of tablet presses.