New Manufacturing Technologies Streamline Laboratory Operations

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-05-02-2017, Volume 12, Issue 5

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

Innovative new technologies are paving the way for more efficient bio/pharmaceutical manufacturing and development. Over the past several months, manufacturers have released a variety of new product offerings for single-use applications, conjugation, measurement, and cloud-based monitoring. The following is a sampling of some recently released technologies for bio/pharmaceutical manufacturing.

New single-use and conjugation technologies for biopharmaceuticals

The Magnetic Conjugation Kit from Innova Biosciences is the newest addition to the company’s range of particle conjugation technologies (1). The new kit allows researchers to covalently conjugate antibodies and proteins to 0.5-µm magnetic particles without the need for extensive optimization of the conjugation reaction, thereby saving antibody or protein. The kit is suitable for use in immunoprecipitation experiments, because covalent attachment provides a more stable alternative to non-covalent antibody attachments using traditional protein A or protein G resin. The treated iron oxide magnetic particles offer a balance between high surface area and separation for efficient binding-achieving high sensitivity with less material and minimizing the risk of non-specific binding.

The single-use gamma-sterilizable SumoFlo flowmeters for biopharmaceutical applications from Malema Sensors is capable of measuring flow rates from 50 g/min up to 100 kg/min with an accuracy of ± 1%  (2). Fabricated from polyether ether ketone, flowmeters are certified to meet USP Class VI, USP 661, and USP 788. The flowmeters are specifically designed to provide single-use flow measurement solutions for biopharmaceutical manufacturing applications including tangential and depth filtration, buffer dilution, cell culture solutions, chromatography, pure water or ultrahigh purity chemicals, and hygienic fluids with varying density or viscosity. Calibration parameters for each sensor are stored on a radiation-hardened memory chip allowing a sensor to be interchanged with any SumoFlo electronics transmitter without affecting measurement accuracy. This interchangeability allows for flexibility and minimal down-time when removing a sensor from service and installing a replacement.

The Quantum Pump from Watson Marlow Fluid Technology Group is a peristaltic pump with patented ReNu single-use (SU) cartridge technology (3). Quantum enables higher downstream process yields throughout the pressure range, delivering virtually pulse-free linear flow and low shear. Flow linearity is achieved across the 43.5 psi (3 bar) single-use processing pressure range up to 5.3 gallons per minute with trace pulsation of only ±1.74 psi (±0.12 bar). An integrated 4000:1 speed control ratio allows users to sustain constant transmembrane pressure in micro and ultrafiltration. The user interface is located at the front of the pump, enabling visual confirmation of operating state and easy access to pump controls even when skid mounted. The ReNu SU cartridge technology enables the pump’s aseptic fluid paths to be positioned accurately. The cartridge slides into position, allowing for a change of fluid path. Quantum’s ReNu SU cartridge offers validation and extractable data in line with BioPhorum Operations Group (BPOG), Bio-Process Systems Alliance, United States Pharmacopoeia, and International Organization for Standardization guidelines. Suitable for gamma irradiation up to 50 kilogray, ReNu SU is manufactured in an ISO Class 7 cleanroom, with all contact material tested for biocompatibility and BPOG-derived extractable studies.

Cloud-based technology for remote pump monitoring 

The new advanced networking drives for Masterflex peristaltic pumps from Cole-Parmer provide options for networking protocols without the need to install gateways or adapters (4). These communication protocols cover a broad range of connectivity and communication with advanced automation control systems. The drives are suitable for industrial networking, bioprocessing, plant automation, or water/wastewater applications. The drive options include native Ethernet/industrial protocol and Profibus bidirectional communication with Bluetooth low energy connectivity and a downloadable iOS-based mobile app to permit local pump monitoring and control. A cloud-based remote pump monitoring capability is available to provide operational status and alerts.

Touch screen balance and moisture analyzer allow for customization

The Cole-Parmer Symmetry touch-screen includes a large, color-resistive touchscreen display that allows workers to easily view weighted results and menu options. The home screen is customizable to individual needs (5). Infrared radiation proximity touchless sensors offer programmable touch-free balance control. Weighing units plus two user-defined units cover most measurement needs. Data can be imported and exported via USB flash drive, and USB, RS-232, or Ethernet offer secure connection. Wi-Fi is available on select models. Free database software is also included with each balance. The expanded line of touch-screen balances includes the Symmetry Touch-Screen B-Series, Symmetry Touch-Screen Advanced P-Series, Symmetry Touch-Screen ultra-micro UMA-T Series and micro balances MA-T Series, and the Symmetry Touch-Screen MB-T Series moisture balances.

Adam Equipment has expanded its line of PMB moisture analyzers. The new PMB 163 offers a capacity of 160 g and readability of 0.01% /0.001 g (6). The PMB 163 joins the PMB 53, which has a capacity of 50 g and provides results at 0.01%/0.001 g, and the PMB 202, which offers a capacity of 200 g and provides results at 0.05%/0.01 g. Moisture analyzers allow scientists, researchers and technicians to rapidly dry samples. The PMB's automatic test-setting function enables recall for frequent testing of items without additional user programming. USB and RS-232 interfaces provide connectivity, while a second USB port allows storage of test programs and data on a flash drive. PMB moisture analyzers are self-contained, needing neither additional software nor a network connection for readings. Users can collect data on a production floor or anywhere power is available. A 400-watt halogen bulb heats samples in 1 °C selectable increments. Three heating options allow test methods and temperatures to be customized for different materials. The PMB offers metal housing, automatic external calibration, capacity tracker, and a levelling bubble. A pan lifter is included to remove samples.

References

1. Innova Biosciences “Innova Biosciences introduces Magnetic Conjugation Kit” Press Release, Feb. 21, 2017.
2. Malema Sensors “Single-use, Gamma-sterilizable Flowmeters for Bio-pharmaceutical Applications” Press Release, March 9, 2017.
3. Watson Marlow Fluid Technology Group “Quantum redefines peristaltic pump performance for single-use downstream processing” Press Release, March 21, 2017.
4. Cole-Parmer “Masterflex® L/S® High-Performance Pump Head from Cole-Parmer Is Redesigned for Enhanced Performance” Press Release, March 23, 2017.
5. Cole-Parmer “New Cole-Parmer Symmetry Touch-Screen Balances Offer
6. Advanced Features, Accuracy and Affordability” Press Release, March 31, 2017.
7. Adam Equipment “Adam Equipment Expands Line of PMB Moisture Analyzers” Press Release, March 2, 2017.