Pharmaceutical

• Highlyadvanced biopharmaceutical plant uses CENTUM, VP Batch, Exaquantum and PRM.
• Total system integration for large-scale biotech production facility.

GlyTech have introduced Yokogawa's Electronic Lab Note of Oprex Informatics Manager.
The ELN enables has made it possible to share data and standardize work.

• Yokogawa provides CENTUM VP with Batch Recipe Management Package for new fine chemical plant.
• Yokogawa's CENTUM VP complies with the requirement of Good Automation Manufacturing Practices(GAMP).

• Uninterrupted Medical Oxygen Production with FAST/TOOLS Monitoring.
• Audits are performed periodically, requiring traceability and the keeping of historical records for all batch production activities.

• RotaMASS was chosen to work with weight measurements and/or differential pressure transmitters for extremely accurate measurements.
• The customer recognized the product's advantages: reliability, accuracy, guaranteed draining system, easily cleaned system, no moving parts, directly built into the pipelines, low pressure losses.

Senju Pharmaceutical selected Yokogawa's Oprex EMS to ensure manufacturing quality.
EMS helps improve operational efficiency while complying with GMP and other guidelines.

Kyowa Hakko Bio monitors vibration trends with Yokogawa's Sushi Sensors to prevent unexpected equipment failures.
By using eServ, sensor data and maintenance information are shared with everyone involved in manufacturing.

Bushu Pharmaceuticals, Ltd., a major contract manufacturing company, is working to eliminate human error to ensure the integrity of test results data, and to promote reliable inspections and paperless operations.

Establish thorough quality assurance with state-of-the-art facilities and technologies to foster the future of medical products.

At Shionogi, the facility maintenance management system eHOZEN, the pr edecessor of eServ, has been used for about 10 years. However, due to the aging of servers and systems, they have begun considering renewing the system with the latest one. When considering this, suggestions from several vendors were received assuming that the system package safely migrates data assets accumulated on the current server and meets the following requirements:

The introduction of eServ has resulted in a centralized system of facility information. The reason for the loss of production opportunities has become clear, and it has become possible for all members to follow up the progress of the measures.

Wide and Clear
Confocal Scanner Unit

• For remote monitoring (of temperature, pressure, and flow volume), installing the SMARTDAC+ GM in the plant and the SMARTDAC+ GX in the office provides for a scalable, pc-free on-site data monitoring solution.
• You can centralize management of large quantities of data by automatically transferring acquired data to a FTP server.

The discharge of improperly treated industrial chemicals and fuel gas can have a major impact on the environment, posing a serious threat to public health. Concurrent with the global growth of manufacturing operations to keep pace with market trends, many countries are taking measures to deal with environmental problems.

For the management of raw materials in the pharmaceutical and cosmetics industries, a manual titration method presents many difficulties. Yokogawa developed the NR800 FT-NIR Analyzer, and with this system, measurements are reliable and stable. It is much easier to control quality.

Cell stage categorized using FucciTime lapse imaging of Fucci-added Hela cells was conducted over 48 hrs at 1 hr intervals. Gating was performed based on the mean intensities of 488 nm and 561 nm for each cell. They were categorized into four stages, and the cell count for each was calculated.

Faster, Brighter, and More Versatile Confocal Scanner Unit

• Colony Formation
• Scratch Wound
• Cytotoxicity
• Neurite Outgrowth
• Co-culture Analysis
• Cell Tracking

Eliminating the wire using wireless transmitter is the perfect solution for rotating equipment. It establishes data collection between the transmitter and the gateway by reliable communication even though the dryer was rotating.

SMARTDAC+ GX series records the clean room temperature, humidity, atmospheric pressure, door openings and closings, etc.

This introduces a system that uses Ethernet communications to acquire measured values, target values, and control output values from a controller installed on site into a PLC at high speed (ten units' worth within one second).

In semiconductor manufacturing processes, a deficient clean room environment can lead to defects and wasted resources, making a strictly controlled clean room indispensable. Maintaining the environment in the clean room requires control of air filters, HVAC systems, room temperature, humidity, airborne particles, and other factors.

In the plants of food and beverage manufacturers, there are times when monitoring and recording of production equipment is necessary inside clean rooms. This is an introduction to monitoring and recording in clean rooms using paperless recorders.

Performing control while changing the set point temperature moment by moment is called running a program pattern (or simply running a program). Sterilization and pasteurization require maintaining specific temperatures for specific durations. 

The paperless recorder DX series automatically calculate the Fo value from the heating temperature and are useful in managing the sterilization process by displaying and recording the value together with the heating temperature.

A critical requirement in biopharmaceutical development is the integration and automation of process equipment and analytical instruments used in the laboratory. Bioprocess labs with multiple lab-scale bioreactors often execute cultivation experiments in parallel for research or process development purposes.

As part of a collaboration between Securecell (Zurich, SW) and Yokogawa Life Science (Tokyo, Japan), this application note demonstrates the effective use of the Lucullus® Process Information Management System (Lucullus®) to assist in the control of three Advanced Control Bioreactor Systems (BR1000) to study glucose utilization of CHO cells for optimal monoclonal antibody productivity.

In the manufacturing process of Pharmaceutical, Chemical and Food & Beverage industries, the cleaning and sterilization of tanks and piping are done with various cleaning solutions, fresh or hot water and steam after manufacturing products. Clean-In-Place (CIP) is the system designed for automatic cleaning and disinfecting.

What if you could detect signs of abnormalities in bus ducts (bus bars) quickly during maintenance and inspection work and respond to them at just the right time? Yokogawa DTSX monitoring solution constantly monitors connections that tend to deteriorate over time and contributes by pinpointing abnormality locations and reducing workload of maintenance personnel, helping to ensure stability in plant operations.

By using the Multibatch function (an option added with SMARTDAC+), you can efficiently record data from multiple devices onto a single SMARTDAC+.

Using the custom display function that comes standard with DXAdvanced means that you can combine the recorders, displays, and switches used in various kinds of equipment.

Using the batch name + lot number system, past measured data can be recalled for reference by batch name.

• Universal inputs provide support for thermocouple, RTD, voltage, and a variety of other input signals.
• Lineup of models for up to 450 inputs.
  Allows multipoint monitoring and recording on a single unit.
• Easily enables network-based data management. 
  file transfers, Web monitoring, and alarm e-mail

By using the computation function of the SMARTDAC+ series Paperless recorder GX/GP, computation option computes the "F-value," or sterilizing value for the sterilization process, so that the computation results can be recorded in the form of data.

The sterilization temperature prior to the filling process is monitored in the field or office. The temperature data is recorded in an external storage medium.

Fluorescent ubiquitination-based cell cycle indicator (Fucci) is a set of fluorescent probes which enables the visualization of cell cycle progression in living cells.

Blending plays a key role in industries such as food, healthcare and chemicals etc. Temperature and vacuum measurements are very important in minimizing the moisture content to ensure the quality of the final product. Strictly maintaining them throughout the process ensures the final product yield.

One of the primary applications for high purity water is for boiler feed water. The measurement of pure water pH can be one of the quickest indicators of process contamination in the production or distribution of pure water. Effective chemical treatment of the feed water is vital in maintaining the useful operating life and minimizing maintenance costs of the boiler.

Industry:Power, Pharmaceutical, Common

With industrial and economic development comes increasingly large and advanced power plants and factories. Nevertheless, we find many cases where the original cables, cable tunnels, and other components of the power infrastructure have languished under continuous operation.

This technical white paper will discuss Yokogawa's CENTUM VP DCS (Distributed Control System) product, hereafter referred to as "CENTUM VP", and the extent of its compliance with Part 11 of Title 21 of the Code of Federal Regulations, (21 CFR Part 11), the Electronic Records / Electronic Signatures Rule.

Yokogawa collaborates with scientists in the medical and pharmacology fields to identify best practices for cell painting and high-content screening, thereby enhancing image analysis and reproducibility.

The worlds of process automation and production management have been converging for some time. What once used to be islands of automation and production management functionality connected through highly proprietary integration schemes that were costly to maintain have developed into integrated platforms that provide seamless data exchange between the world of automation and the plant floor, the functions of production and operations management, and integration with business level systems.

The world of process automation is governed by procedures. While we like to refer to the process industries as being largely "continuous", this could not be further from the truth. Process manufacturing is constantly in flux.

From engineering to installation, commissioning, operations, and maintenance, FOUNDATION fieldbus offer significant cost reductions of 30 percent or more versus conventional analog systems. Many of these cost reductions come from the advanced functions that fieldbus offers versus analog technology.

This document describes the operation and data flow of the Yokogawa Print Wave software using the DX-P Reporter. It will provide a detailed explanation of the Advanced Alarm Reporter functions. The functions described in this paper were first released in Print Wave version 5.5.

Discovering your Baseline with OT Security Risk Assessment

The first stage in creating next-generation production control system that achieves innovative plant operation is providing "Visualized operation". "Visualized operation" for the customer means that he can reliably access and visualize plant data regardless of plant location and time.

Lonza's Riverside plant manufactures bulk active ingredients for the pharmaceutical industry. A new, fully automated multipurpose reactor train was installed in early 1996. The train includes ten 500 to 1500 gallon vessels used for reaction, distillation, phase separation, and crystallization; two centrifuges for isolating finished products; and two dryers. 

Manufacturers that are digitalizing lab information management can improve quality and streamline operations. Read the complete article inside.

Yokogawa Insilico Biotechnology released its Insilico Digital Twin Factory, which can help drugmakers increase productivity and bring down manufacturing costs and time to market by potentially replacing up to 50% of the experiments needed during the process development, characterization and scale-up of biopharmaceuticals.

Yokogawa Electric began offering the environmental monitoring system "OpreX Environmental Monitoring System" (hereinafter, OpreX EMS) for the pharmaceutical and medical device industries in October 2020. OpreX EMS, which was launched simultaneously domestically and overseas, is based on customers' needs, such as regulatory compliance, diversification of operational risks, and high usability. When asking the person in charge about the development history and features of the product, it was found that it is a new solution that meets the company's business vision.

The critical steps in achieving advanced process control include building an accurate digital twin of a bioreactor, validating it, and establishing communication between the bioreactor and its digital twin. Several of these steps are already mature and Yokogawa is making rapid progress toward realizing ‘smart’ bioreactors for smart manufacturing.

Exploring the technologies needed to achieve automatic control of cell culture processes.

Unlocking the Keys to a Sustainable Pharma Supply Chain

Yokogawa Insilico Biotechnology released its Insilico Digital Twin Factory, which can help drugmakers increase productivity and bring down manufacturing costs and time to market by potentially replacing up to 50% of the experiments needed during the process development, characterization and scale-up of biopharmaceuticals.

Assets and operations will have human-like learning and adaptive capabilities, allowing responses without operator interaction to situations within a secure, bounded domain.

The use of optical fiber for temperature sensing is expanding beyond safety applications. 

The wireless standard LoRaWAN enables wireless communications and digital transformation over long distances, supplementing in-plant wireless networks such as ISA100.

Cloud-based wireless sensing enables safety, reliability, and profits through widespread asset monitoring.

Process automation systems are increasingly connected to IT systems and the outside world, introducing cybersecurity concerns, which can be addressed using techniques such as software-defined networking and monitoring services.

Asset management plays a key role in operational safety, and it is critical to capture and transmit these data in a secure, digitized way to ensure that they are up to date, accurate and easily accessible.

Robots have long been used in discrete manufacturing and machine automation applications, and their use is now spreading to address process industry applications.

Historians provide the data storage, secure connectivity and built-in tools required for implementation of digital transformation initiatives.

The Yokogawa business vision states that the company endeavors to achieve Net-zero emissions, ensure the Well-being of all, and make a transition to a Circular Economy by 2050. 

Connecting MES and DCS in your pharma or biotech factory: Werum PAS-X MES and Yokogawa CENTUM VP

YOKOGAWA will contribute to technology evolution particularly in measurement and analytical tools to help build a world where researchers will increasingly focus on insightful interpretation of data, and advancing Life Science to benefit humanity.

Showcases the OpreX Intelligent Manufacturing Hub, an AI-enabled platform that enhances manufacturing with seamless data integration, intelligent reporting, optimized workflows, and advanced visualization for smarter decision-making and efficiency.

By equipping SMARTDAC+ with the advanced security features option "/AS", it meets the strict requirements of the U.S. FDA 21 CFR Part 11 and supports DI in compliance with PIC/S and ALCOA+ by WHO, MHRA and FDA.

Our approach is to leverage state-of-the-art technologies for real-time monitoring and predictive control that allow virtual environments where "digital twin" processes can provide distinct advantages.

As a gateway to further expand Yokogawa's messaging as a One-stop Solution Business, Yokogawa has partnered up with INCIT, to introduce the S.I.R.I. framework. 

By adopting the environmental monitoring system, we were able to create an environment in the cell storage facility that allows for quality control, maintaining a high level of safety.

Yokogawa leverages our extensive knowledge and experience in IT, operation and control technology to build an advanced improvement cycle that is useful to all management levels, and eventually aims to achieve Pharma 4.0 together with our customers.

Physiologically relevant 3D cell models are being adopted for disease modeling, drug discovery and preclinical research due to their functional and architectural similarity to their tissue/sample of origin, especially for oncology research. Multifunctional profiling and assays using 3D cell models such as tumoroids tend to be manual and tedious. Further, high-content imaging of biomarkers in 3D cell models can be difficult.
In this two-part webinar present to you streamlined technologies which can bring consistent timesaving, ease-of-use, and high-quality data to your 3D cell-based workflows:

(A)  The Pu·MA System is a microfluidics-based benchtop automated device for performing “hands-off” 3D cell-based assays. In this webinar, application scientist Dr. Katya Nikolov will present data from optimized assays using tumoroids followed by Yokogawa’s high-content imaging systems for biomarker detection.

(B) Yokogawa’s high-content imaging systems such as CellVoyager CQ1 provide superior confocal imaging using the Nipkow Spinning Disk Confocal Technology. Here, application scientist, Dan Collins will present details of the high-content imaging capabilities, easy to use and intuitive image acquisition software, especially for increasing productivity and a streamlined workflow.

Learn How:

• The open platform, Pu·MA System can be used to automate your 3D cell-based assays
• To perform automated IF staining for biomarkers using tumoroid models without perturbing your precious samples
• Image acquisition from 3D cell models using Yokogawa’s high-content imaging platforms
• Image analysis from cells, complex spheroids, colonies, or tissues using the CellPathfinder high content analysis software

In this webinar, Professor Jonny Sexton discusses a pipeline, developed in the Sexton lab, for the quantitative high-throughput image-based screening of SARS-CoV-2 infection to identify potential antiviral mechanisms and allow selection of appropriate drug combinations to treat COVID-19. This webinar presents evidence that morphological profiling can robustly identify new potential therapeutics against SARS-CoV-2 infection as well as drugs that potentially worsen COVID-19 outcomes.

Physiologically relevant 3D cell models are essential for drug discovery and preclinical research due to their functional and architectural similarity to solid tumors. One of the challenges faced by researchers is that many of the assays using these precious samples tend to be manual and tedious.

Using proprietary microfluidics technology, Protein Fluidics has created the Pu·MA System for automated complex 3D cell-based assays. In this webinar, application scientist Dr. Katya Nikolov will present her work on combining this novel automation technology with Yokogawa’s high-content imaging systems for biomarker detection in 3D cell models. Nikolov will demonstrate the utility of an automated immunofluorescence staining workflow followed by confocal imaging within the Pu·MA System flowchips. This automated workflow enables quantitative assessment of biomarkers which provides valuable data for further understanding disease mechanisms, preclinical drug efficacy studies, and in personalized medicine.

This webinar will explore:

• The Pu·MA System and novel technology for automated 3D cell-based assays
• How to perform automated immunofluorescence staining for biomarkers with a “hands-off” assay workflow
• How to visualize biomarkers after the assay with high-content imaging within the flowchip

This webinar highlights Yokogawa’s High Content Solutions, the benchtop confocal CellVoyager CQ1, and CellVoyager CV8000. Utilizing Yokogawa’s dual-wide microlens spinning disk confocal technology, these automated HCA systems provide remarkable image quality while increasing your output. This frees up time to complete other research activities. Also, recent additions to the CSU-W1 confocal upgrade is discussed. The SoRa, a super-resolution solution, and the Uniformizer, an image flattening device. Both of which can be added to the lightpath of your CSU-W1-enhanced microscope.

Agenda:
Introduction to Yokogawa
SoRa for CSU-W1 super-resolution with confocal
Two high content instruments from Yokogawa: The CQ1 and the CV8000

Presenter:
Dan J. Collins, Applications Scientist, Yokogawa Life Science

In the last few decades, the pharmaceutical industry has transformed people’s lives. However, the development of new drugs is becoming increasingly difficult and a paradigm shift in the drug discovery workflow is required to reduce attrition and transform conventional drug screening assays into translatable analytical techniques for the analysis of drugs in complex environments, both in-vitro and ex-vivo. The ability to visualize unlabelled compounds inside the cell at physiological dosages can offer valuable insight into the compound behavior both on and off-target.

SiLC-MS is a semi-automated methodology that allows the collection of intracellular contents using a modified CQ1 imaging system developed by Yokowaga. The instrument is equipped with a confocal microscope that allows bright field imaging as well as fluorescence imaging with 4 lasers (405, 488, 561, and 640 nm). Sampling is performed using the tips developed by Professor Masujima (1-4).

In this study, we show the applicability of the SiLC-MS technology to drug discovery, as it is crucial to identify compound and its metabolites when incubated in a mammalian cell at a therapeutic dose. We report on the validation studies performed using the SiLC-MS platform, in these validation studies we assess the ability to distinguish different cell types based on their metabolomic fingerprint, furthermore, we have also evaluated if this assay was sensitive enough to detect drugs intracellularly.

Presenter: Carla Newman, Scientific Leader (Celluar Imaging and Dynamics), GSK

Generating translatable high-content imaging data from physiologically-relevant cell models, including 2D and 3D structures, is extremely valuable for drug discovery and pre-clinical research. In this webinar, James Evans, CEO of PhenoVista Biosciences presents case studies on how Yokogawa’s Benchtop CQ1 Confocal System can improve throughput and standardize processes for complex 3D cell-based phenotypic assays.

Key learning objectives:

• Strategies for designing and implementing high-content screening assays
• Approaches for deciding between 2D and 3D model systems

3D imaging experts from Yokogawa and Insphero have come together to provide helpful tips and tricks on acquiring the best 3D spheroid and organoid imaging. This webinar focuses on sample preparation, imaging, and analysis for both fixed and live cells in High Content Screening assays. The experts also discuss automated tools that can help researchers understand the large volume of data in these High Content Imaging Analysis Systems.

Visualizing the complex spatiotemporal dynamics of human stem cells as they proliferate and make cell fate decisions is key to improving our understanding of how to robustly engineer differentiated tissues for therapeutic applications.

In this webinar, Dr. Rafael Carazo Salas will describe multicolor, multiday high-content microscopy pipelines that his group has recently developed to visualize the dynamical cell fate changes of human Pluripotent Stem Cells (hPSCs).

Key Topics:

• Visualizing how human Pluripotent Stem Cells (hPSCs) proliferate and undergo early differentiation in vitro, by high content microscopy
• Learning about experimental and computational pipelines that enable monitoring single-cell fate dynamics
• Learning about novel “live” reporters of hPSC cell fate

Speaker
Rafael Carazo Salas, PhD
Professor, School of Cellular and Molecular Medicine
University of Bristol

Image-based phenotypic screening relies on the extraction of multivariate information from cells cultured in a large number of screened conditions. In this webinar, we explored the application of complex and biologically relevant model systems for drug screening, such as small intestinal organoids.

Key topics include:

• Learn how to upscale, streamline, and automate intestinal organoid handling
• Learn how to image in complex three-dimensional (3D) model systems and how to approach large imaging datasets
• Understand the basics of multivariate analysis on image-inferred features