Pharmaceutical Technology Editors

ROSS FDA-50 Fixed Tank Dual Shaft Mixer |© Charles Ross & Son Company

The ROSS FDA-50 Fixed Tank Dual Shaft Mixer is a custom-design agitated pressure reactor built to handle a wide range of formulations and viscosities. It is ideal for processes that require meticulous control over mixing, temperature, and pressure and comes in a compact, portable module. The design comprises a stainless-steel type 316 dished bottom vessel and removable dished cover that can accommodate internal pressures of up to 100 psi. The mixer/reactor is equipped with two agitators and has a high-speed disperser with two 6” sawtooth blades (one fixed at the bottom and one adjustable along the shaft), driven by a 5 HP explosion-proof motor that moves up to 1760 rpm. This speed creates a vortex into which dry ingredients can be delivered for fast wetting. The disperser is belt-driven and has a removeable drive motor, belt, and guard. In addition, the two-wing anchor agitator is direct-driven by a 5 HP explosion-proof removable gearmotor that moves up to 45 rpm. The agitator is designed with a heavy-duty triangular cross-section and has removeable Teflon sidewall scrapers. The anchor feeds product toward the high-speed disperser blades, ensuring that batch contents do not stagnant in any one area. The mixer shafts use dry-running single mechanical seals that are compatible with various solvents. In addition, all product wetted surfaces are polished to a 320-grit finish. This mixer/reactor also houses a 2” flush tank discharge ball valve that leads to a sanitary outlet connection. It also contains an assortment of sanitary inlet ports on the cover. The mobile mixer remains stable on four splayed stainless-steel legs with foot pads and non-marking urethane casters, two of which lock and two of which are rigid. The casters make it easy to move the unit around.

Articles

The ROSS FDA-50 Fixed Tank Dual Shaft Mixer is built to handle a wide range of formulations and viscosities and is ideal for processes that require meticulous control over mixing, temperature, and pressure.

Fixed Tank Dual Shaft Mixer/Pressure Reactor

MilliporeSigma Mobius ADC Reactor| © MilliporeSigma

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, introduced the Mobius ADC Reactor, a single-use reactor designed specifically for the manufacture of antibody drug conjugates (ADCs). The reactor is the first of its kind for ADC production, according to the company. The Mobius ADC Reactor is designed to meet the unique requirements for linking the necessary components for ADCs and aims to enable these critical therapies to be produced faster and more safely with faster turnaround times and fewer cross-contamination risks. Performance improvements using the single-use reactor include elimination of potent liquid waste and a 70% increase in efficiency. The reactor’s single-use assemblies are made of Ultimus Film technology, which provides enhanced bag strength, improved durability, and leak resistance.

The Mobius ADC Reactor is the first single-use reactor designed specifically for the manufacture of antibody drug conjugates.

Single-use ADC Reactor

CPC MicroCNX ULT Series aseptic microconnector | © CPC

The MicroCNX ULT Series from Colder Products Company (CPC) is the first aseptic micro-connector that can be fitted directly into freeze cassettes used in cell and gene therapy (CGT) processing. It can be frozen to -190 °C. It is compatible with the most common types of tubing, including polyvinyl chloride (PVC), used in developing advanced therapies. The connectors are compact enough to fit into a freeze cassette and can be frozen with vaporized liquid nitrogen. They are designed to provide a simple, efficient method of sterile connection of tubing used for small CGT assemblies. They also eliminate the need for adding extra tubing into the process, thus helping to reduce the amount of product hold-up or product loss. The MicroCNX ULT series termination and flow path are constructed from polyphenylsulfone, a high-performance polymer that is chemically compatible with the harsh chemicals, such as dimethyl sulfoxide, used in cryopreservation processes. This new series adds to CPC’s 1/8” MicroCNX Series Connectors, an alternative to tube welding in creating closed sterile connections at small volumes. Similar to earlier MicroCNX products, the MicroCNX ULT series features a 1/8” flow path and offers options for 1/8”, 3/32”, and 1/16” hose barb terminations to support a variety of tubing sizes and materials, such as PVC, silicone, and thermoplastic elastomer.

CPC’s MicroCNX ULT Series represents the first aseptic microconnector that can be fitted directly into freeze cassettes for GCT production.

Aseptic Micro-Connector

Sartorius Vivaflow SU cassette | © Sartorius

Sartorius’ Vivaflow SU tangential flow filtration (TFF) is designed to be more user-friendly and to allow for more flexibility in laboratory workflows. The new cassette offers more efficient and sustainable ultrafiltration and diafiltration processes for feed volumes in the range of 100 mL–1000 mL. Vivaflow SU is an all-in-one cassette, which reduces cost and complexity and streamlines workflows for molecule isolation. Each cassette is ready to use and has a standard laboratory pump for simple set-up, which avoids the need for expensive systems and expensive process optimization. It also allows for faster and more reliable concentration and rebuffering of any molecule. The cassette eliminates the need for cleaning and reduces contamination risk while minimizing waste. Sustainability features include a new housing that uses 30.5% less plastic. It also incorporates several eco-friendly design improvements, such as locally sourced raw materials, customized tubing kits for each cassette configuration, a digital user manual, and reduced non-recyclable packaging; all of which are meant to contribute to a lower research footprint. Vivaflow SU is the-next-generation TFF cassette that replaces the previous Vivaflow 50 model. It is applicable for research scientists who require a fast and reliable means for concentrating and rebuffering large feed volumes in molecule isolation workflows.

The new cassette offers more efficient and sustainable ultrafiltration and diafiltration processes for feed volumes of 100 mL–1000 mL.

Tangential Flow Filtration Cassette

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.

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.