Pharmaceutical Technology Editors

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.

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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’s NexGen Press line of tablet presses | Image Credit: © GEA Pharma & Healthcare

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.

Next-Generation Tablet Press

Syngene International, a contract research, development, and manufacturing organization (CRDMO), now offers a new protein production platform aimed at rapid protein synthesis. The platform uses a cell line and transposon-based technology that Syngene licensed from ExcellGene, a Switzerland-based service provider specializing in mammalian cell line development. 

Editor’s note: this article was published in the Aug. 1, 2024 issue of 

The new protein synthesis platform, combined with Syngene’s clone selection and development processes, offers significant improvement in efficiency and precision. The platform offers faster preclinical and clinical development and shorter timelines to product launches, shortening time to market. Advantages include up to 10 weeks reduction in time versus traditional cell line development methods; better predictability and protein yields, with high-titer levels of up to 10 g/L achieved; support for a variety of modalities, including monoclonal antibodies, biosimilars, bispecific antibodies, antibody drug conjugates, and other recombinant proteins. In addition, the platform’s versatility facilitates integration with perfusion and fed-batch manufacturing processes.

Syngene’s protein production platform uses a cell line and transposon-based technology licensed from Switzerland-based ExcellGene.

New Protein Production Platform

Thermo’s DNAPac RP HPLC columns | Image Credit: 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 (pictured here) 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.

These columns offer fast run times, optimal separation efficiency, and reliable results.

Separation and Purification Columns

The ROSS Model HSM-405SC-25 Inline High Shear Mixer with solids/liquid injection manifold (SLIM) Technology is designed for production floors that require flexibility. The stainless-steel portable skid features a built-in workbench that helps save time and money. It allows the mixer to be used anywhere in a plant, eliminating the need for separate mixers for each vessel or product.

As an external mixer, the Inline SLIM can be piped to the recirculation loop of virtually any size vessel. Featuring sanitary tri-clamp connections, this 3A-compliant machine can be cleaned in place or quickly disassembled for deep cleaning and sanitation. Using the tabletop workbench, operators can open bags and load powders into the hopper that sits on top of the mixer, ensuring a consistent feed and minimizing aeration.

The SLIM is a unique rotor/stator device capable of injecting powders directly into a fast-moving liquid stream without the use of an eductor or pump. Engineered for high-speed and high-volume mixing requirements, this device can wet out powders and create a fine immediate dispersion, greatly reducing the occurrence of floating powders, lumps, and agglomerates.

The ROSS Model HSM-405SC-25 Inline High Shear Mixer features a built-in workbench and is designed for production floors that require flexibility.