Speeding cell and gene therapy commercialization
The clinical manufacturing process of cell and gene therapies predominantly uses viruses as the vehicle to deliver the genetic information into the patients’ cells. However, viral engineering processes are hampered by timelines that take months, cost millions of dollars and require significant infrastructure and downstream regulatory testing.
As an alternative, Kytopen’s Flowfect technology is a flexible, complete technology solution for non-viral cell engineering that integrates the discovery, development, and manufacturing of cell and gene therapeutics. According to the company, the platform speeds therapies from the clinic to commercial use by enabling cell engineering without compromising functionality or viability. Ultimately, the non-viral process yields billions of high-quality engineered cells in minutes while maintaining cell health and function.
“Our Flowfect technology utilizes a novel combination of electrical energy and continuous fluid flow to engineer cells,” Bethany Grant, head of research and development at Kytopen, said in a statement. “Our ability to engineer billions of cells in minutes with minimal disruption unlocks new opportunities to enable curative therapies in autologous or allogeneic therapeutic applications.”
A frictionless future
According to LiquiGlide, an MIT-based startup, “Innovation is stuck. To flow, we need invention.” With that goal in mind, the company has innovated a patented coating that it says eliminates friction between liquids and solids — reducing waste and lowering costs.
So far, the company has found uses for its new coating in a number of manufacturing industries including consumer products and medical devices. In a biopharma setting, LiquiGlide says the coating can lower yield loss by reducing friction between high viscosity, high-value pharma products and their containers.
“In addition, the need for overfilling these products in delivery systems is high due to their high viscosity,” the company says. “LiquiGlide’s technology can help substantially reduce yield loss and overfilling in manufacturing, processing, and filling, thus helping to make the supply chain much more efficient.”
Overcoming formulation challenges
Using highly concentrated protein solutions presents drug developers with specific difficulties in formulation and manufacturing. To help overcome these issues, MilliporeSigma has launched an excipient technology platform that reduces viscosity while maintaining protein stability.
Called the Viscosity Reduction Excipient Platform, the core of the solution uses a combination of one amino acid and one anionic component. The company says that a variety of excipient combinations are then available as part of the platform to address specific needs for protein-based therapeutics including “viscosity reduction beyond reduction with single excipients” and “improved balance of viscosity vs. stability.”
According to MilliporeSigma, the synergistic effects of the excipient combinations used in the platform deliver several advantages including: reducing the viscosity of highly concentrated protein therapeutics such as mAbs to enable subcutaneous formulation; increasing concentration of plasma protein-based therapeutics; improving the ability to handle high concentration formulations in downstream processing; enabling competitive differentiation via protected intellectual property and technology licensing.
Automating synthetic biology workflows
With the pressure on drug developers to quickly innovate needed therapies, CODEX DNA has created a benchtop solution that accelerates the design-build-test phases of the product development cycle.
As the world’s first and only hands-free and fully automated synthetic biology platform, the BioXP 3250 system is designed for DNA assembly, cloning and amplification. It also enables automated high-throughput synthesis of genes, clones, variant libraries and mRNA — and works overnight.
“Our users now have greater flexibility to generate full-length genes or long DNA constructs at unprecedented rates, reducing iteration cycle times,” the company says. “The BioXp system is designed to improve productivity, reduce turnaround time, increase throughput and scale, enhance quality, and enable complete workflow control for both synthetic DNA and mRNA formats.”
Expediting packaging with automation
As pharma manufacturers worldwide push to produce billions of COVID-19 vaccines at an unprecedented pace, upgrades to operations, such as adding continuous labeling capabilities, will help expedite high-volume vial production.
Now, HERMA US, subsidiary of HERMA GmbH, a Germany-based provider of labeling machinery and self-adhesive labels and materials, has introduced continuous labeling capabilities for its 132M HC wrap-around labeler that add speed without sacrificing accuracy.
The company says that continuous operation is made possible by two new modules — EasySplicer and EasyCutter — that can be retrofitted onto existing machines. The new add-ons allow label and backing paper reels to be changed or disposed of without production interruptions. Because high speed labelers typically have to be stopped every 10 minutes to change the reels, this upgrade will result in a significant reduction in downtime.
The EasyCutter vacuums also improve sustainability efforts by collecting empty backing paper and chopping it into shreds that are collected automatically and can be recycled.
Safer automation with robots
Robotics have transformed many areas of pharma’s warehouse operations, adding speed and ease to packing and moving containers. But companies are often hampered by the high cost of installing fixed infrastructure for robotic operations.
To overcome this obstacle, Boston Dynamics has innovated Stretch — a small, box-moving robot with an omni-directional mobile base that allows it to navigate loading docks, maneuver in tight spaces and adapt to changing facility layouts.
The multi-purpose mobile robot can tackle a number of tasks where rapid box moving is required, first starting with truck unloading and later expanding into order building. Stretch is also equipped with a custom-designed lightweight arm and a smart-gripper with advanced sensing and controls that can handle a large variety of boxed and shrink wrapped cases.
Boston Dynamics is currently seeking customers to pilot test deployments of Stretch with truck unloading tasks ahead of its commercial deployment in 2022.
Traceability and serialization of pharma products is an ongoing requirement in the industry — and an ongoing challenge. Because small serialization codes are difficult to read, pharma manufacturers often have to print onto secondary packaging or lids. Now, Mettler Toledo PCE has innovated a solution for serialization and aggregation that delivers the full picture of what’s happening on the filling line.
Called the T60 Integrated 360 Series, the solution serializes directly to applied labels while verifying content and checking for defects. It then obtains a full 360-degree view of products on the conveyor for final insertion into secondary packaging. To achieve its 360-degree view, the solution uses a unique camera configuration and six image sensors.
The track and trace solution works for a variety of bottle sizes, can be integrated into existing packaging lines and provides an extra line of quality control and code verification capabilities.
To truly secure the supply chain, distribution routes not only need to be strengthened and maintained, but the drugs within those routes need to be protected as well.
With the aim of securing product integrity, Hoffmann Neopac has now introduced a tamper-free version of its Nozzle Tube solution. Developed for topical disinfectant solutions, eye ointments, creams, gels and some oral care products, the tubes come in a variety of sizes for different volumes. The tubes are also made with a proprietary blend of materials that provide advanced barrier properties that protect against moisture, oxygen and other potentially harmful factors.
In addition, the tamper-free nozzles now help protect against counterfeiting and other illicit activities to provide end-user safety and reassurance.
Capping multiple SKUs
When it comes to packaging complexity, handling multiple stock-keeping units (SKUs) remains an ongoing challenge to manufacturers. Now, TurboFil Packaging Machines has introduced the Acrobat Chuck Capper, a servo-driven chuck capper ideal for manufacturers producing a variety of caps and bottles.
Made with proprietary technology and parallel belts, the capper helps lower the cost of changeovers to different bottles. The Acrobat’s servo motor offers precise, repeatable torque control and counterclockwise thread seating for difficult threads. Its novel “chasing chuck” system also automatically locates the next bottle along the belt.
The system’s positive placement and cap-specific stainless steel serrated pneumatic chucks help assure gentle handling of different products. According to the company, the Acrobat can handle caps up to 3” in diameter including flat, port, hinged, child-resistant, continuous thread, twist top, metal lug, tilt top and tamper-evident varieties. At just 73” X 75”, the system is also compact to help optimize floorspace.
High-speed cartoning for pre-filled syringes
As the demand for pre-filled syringes, vials and other delicate pharma containers continues to climb, manufacturers are dealing with pressure to keep pace in all phases of manufacturing and packaging. With that goal in mind, IWK Packaging Systems has introduced a modular, high-speed top-load cartoning line called the IWK TL Series that the company says offers numerous advantages over conventional top-loading cartoning equipment.
According to the company, the IWK TL Series offers safe, reliable product handling that eliminates glass-to-glass contact through an intelligent transport system not typically found in top-load units. To account for variability in operations, manufacturers are able to employ an individually adaptable setup instead of using a fixed distance between carton holders.
The IWK TL Series is also modular with a monoblock design that allows for mixing and matching various stations per product-specific needs including product feeding carton erection and divider insertion units prior to transport to end-of-line closure, reject and discharge modules.
All told, the company says that the series provides reliable product handling with a novel transport system, station flexibility for shifting needs and quick changeover to minimize downtime at a time when there are “continued efforts to produce billions of COVID-19 vaccine doses.”
A flowmeter that fits any pipe
Finding an ideal installation point for flow measurement devices can be a challenge in process plants, partly because of the requirements for long length of inlet run and undisturbed flows. Now, Endress+Hauser has introduced the Prosonic Flow P 500 measuring system with its unique FlowDC function to overcome this challenge.
According to the company, the device, which needs minimal straight inlet runs, can be installed directly onto the outside of the pipe, eliminating operation disruptions. Thanks to this approach, the system works in nearly any location, making it a flexible and adaptable option to a wide variety of existing pipes.
The Prosonic Flow P 500 is suitable for a range of applications including water, acids, solvents, chemicals and more. It can also handle a variety of critical tasks including quantity and volume measurement, leak detection and process monitoring.
In addition, the flowmeter comes with several high-tech features including HistoROM, which provides data storage and security; digital signal processing, which allows the meter to simultaneously record multiple measured values for process control, such as volume flow, flow velocity, and sound velocity; and Heartbeat Technology that enables permanent self-diagnostics with the highest diagnostic coverage.
The strict environmental regulation surrounding solvents make them a costly and risky ingredient for manufacturers to use. As more drugmakers look for ways to reduce their use of solvents, Evonik has innovated a “Chemistry in Water” solution that offers a sustainable alternative.
According to the company, “‘Chemistry in Water’ or ‘micellar chemistry’ uses surfactants which form microscopic spheres in water, called micelles. These function as nanoreactors and enable organic reactions, which are generally run in organic solvents, to be performed in water.”
Evonik says it collaborated with Professor Bruce Lipshutz, an organic chemist at University of California, Santa Barbara, to develop the technology and then integrated it into its CDMO portfolio. Evonik is now marketing the technology and says it could be used for wider adoption in a number of industrial processes.
“Apart from reducing the need for organic solvents in organic reactions, micellar chemistry also has the potential to generate higher yields and increase selectivity under mild conditions. Significant reduction of catalyst loading, energy consumption and waste production has been achieved using this approach for many reaction processes,” the company says.
Standardizing content management
Legacy and other document management systems require companies to invest months defining requirements and customizing configurations. Even then, employees often find workarounds when it comes to sharing quality documents, which can increase compliance risks.
Recently, Veeva Systems announced the availability of the Veeva Quality Content Reference Model to advance quality transformation efforts and drive further standardization in quality management. For the first time, the company says that documented best practices from hundreds of successful implementations of Veeva Vault QualityDocs will be available to accelerate systems deployment, and drive consistent and compliant GxP content practices across the enterprise.
In pharma, there are currently no widely accepted standards for managing quality content. Now, Veeva’s reference model will streamline the process by providing a standard document hierarchy, taxonomy, and metadata for organizing and delivering quality content. It can also be used to streamline collaboration with contract partners.
The reference model is also free, and any company can apply the content management best practices to harmonize processes and improve collaboration with partners across the product life cycle.
Hands-free remote work
As COVID-19 protocols continue to create the need for remote workers in manufacturing, easy communication solutions are needed for frontline workers. With this goal in mind, Imint Image Intelligence AB has combined its video software know-how with RealWear’s industrial-grade assisted reality connected devices to create an enhanced head-mounted device.
According to the companies, RealWear’s upgraded HMT-1 device now offers “the industry’s clearest, most stable video performance to frontline workers who need hands-free access for visual communications.”
With its voice-enabled technology, the device offers frontline workers clear, real-time access to documents, workflows, visual data and remote experts. In particular, the device incorporates Imint’s Vidhance Video Stabilization and Vidhance Dynamic Blur Reduction, which compensate for camera shake and deliver stable video feeds, even in low-lit conditions.
All told, the enhanced video software gives remote technicians better visuals on what frontline workers are seeing — all while maintaining a safe distance.
Enhancing robotics know-how
Manufacturing companies are finding more ways to leverage the power of robotics for dangerous or monotonous tasks in facilities. Now, with the help of ArtiMinds Robotics, Merck has set up a prototyping and training platform for collaborative robotics at its site in Darmstadt, Germany. In addition to helping the Big Pharma company deepen its understanding of robotics expertise, the new training will evaluate the feasibility of the system in safety engineering.
“In addition to being used as a training platform, the system is also used for an early testing of robot applications. To build the robot’s working environment, we use rapid prototyping technologies such as 3D printing,” explains Benedikt Ulmke, senior project manager, Digital Engineering. “Our goal is to be able to quickly assess, with little effort, whether a workflow is suitable for collaborative robots and whether we can make our production processes more efficient by using them.”
For easy implementation, ArtiMinds RPS replaces textual programing with a graphical, intuitive user interface of the robotic programming software. According to the companies, the extensive template library also “covers a wide range of tasks, such as pick and place and camera-based detections but also demanding applications like force-sensitive joining of components.”
With the goal of encouraging curiosity during industrial training, Merck hopes the system will help engineering trainees understand how to best implement the robotics system.
A CO2 incubator for cleanrooms
With the dramatic increase in demand for advanced therapies, there has been a sharp rise in the need for incubators equipped for use in controlled cleanroom environments. To meet that need, Thermo Fisher Scientific has launched its first-ever GMP and cleanroom-compatible CO2 incubator to support cell therapy developers.
Called the Heracell Vios CR CO2 Incubator, the new technology provides optimal cell growth for even the most sensitive high-value cell cultures. The incubator’s fully enclosed casing and electronics minimizes particle emissions in sync with critical particulate control in Grade A/B cleanrooms.
“Operating on the patented Thermo Scientific THRIVE active airflow technology, which delivers homogenous cell growth conditions and rapid parameter recovery in less than 10 minutes, the system prioritizes cell culture protection,” the company says.
It also comes with a range of cleanroom-compliant accessory options, including stacking adapters and roller bases to facilitate easy insertion into established laboratory processes.
An animal-free alternative to BET testing
For decades, horseshoe crabs have been integral to the safe production of vaccines and injectables. In particular, injectable drugs must be tested for bacterial endotoxins using a Bacterial Endotoxins Test (BET) — also known as the Limulus Amebocyte Lysate (LAL) test. But the process, which involves the bleeding of live horseshoe crabs, is an unsustainable practice.
Now, to provide the industry with an alternative method, the Associates of Cape Cod, a Seikagaku Group Company, has launched a new, sustainable recombinant LAL reagent, PyroSmart NextGen for BET.
According to the company, lab analysts can maintain the same test method, sample preparation, and plate reader instrumentation used for traditional BET tests because the PyroSmart NextGen reagent is a recombinant cascade reagent (rCR) and follows the same enzymatic cascade pathway as traditional naturally sourced reagents. The new reagent is a direct replacement for naturally sourced reagents and eliminates the need to purchase new specialized instrumentation as required by first generation recombinant reagents.
As an added bonus, the PyroSmart NextGen can be used for a wide variety of endotoxin tests, ranging from standard water testing to samples requiring high sensitivity, such as intrathecal products and those requiring high dilutions to overcome interference.
Working in a lab comes with a number of safety challenges, including burns and electrical shock hazards that can occur when heating or stirring samples. To help keep workers safe, Cole-Parmer has released its Stuart Undergrad hot plates and stirrers with a number of practical safety features.
When the temperature rises above 50 degrees Celsius on the new unit, a “hot” warning light flashes and stays lit until it reaches a safe temperature. According to the company, the model, which is available in digital and analog, is also “designed to direct spills away from the control panel and equipped with microprocessor-controlled dual thermocouples for accurate temperature control and protection from overheating.”
In addition, the unit includes the company’s BioCote technology, which is formulated from silver ion additives to provide built-in antimicrobial protection, so the range can support a more hygienic laboratory environment.
“By reducing levels of odor and stain causing microbes such as bacteria, mold and fungi, BioCote technology is proven to offer antimicrobial protection for the expected lifetime of the product,” the company says.
Improving particle characterization
In drug development, orthogonal particle characterization methods are regulatory requirements, especially for protein-based biologics. Although light obscuration (LO) instruments have traditionally been used to provide size and count data, the technique is not enough to ensure product quality and stability.
Now, Yokogawa Fluid Imaging Technologies’ new LO instrument bridges the gap between compliance and formulation with a single solution. Called the FlowCam LO, the instrument combines Flow Imaging Microscopy (FIM) with LO to generate data for compliance standards while allowing verification with high-resolution images.
“Over the past ten years FIM has become one of the essential tools used in the biopharmaceutical industry due to its ability to accurately identify and classify subvisible particles in liquid media,” the company said in a statement. “With automated high-resolution imaging, particle identification and morphology are confidently and readily determined and displayed in real-time, speeding up formulation development.”