This video, which has 3,000+ views, explains cell culture best practices and their role in improving reproducibility and reliability when culturing cells.

This video, which has 92,000+ views, utilizes a narrative coupled with animation to explain the principles of Raman Spectroscopy.

This video on Protein Purification provides insight into the process and tools that scientists and engineers use to explore proteins.

This video, which has 165,000+ views, provides an informative overview of the principles at work in four types of flowmeters; Mechanical, Magnetic, Vortex and Ultrasonic.

This video, which has 2,300+ views in its first 24 hours online, explains Ethernet/IP. It explains both what it is, and perhaps just as importantly, what it is not.

At METTLER TOLEDO we uphold the tradition of Swiss craftsmanship in the production of our pH sensors and other analytical instruments, and now combine it with digital technology. See in this video how we produce our Intelligent Sensor Management (ISM) pH sensors at our manufacturing facility in Urdorf, Switzerland. ISM sensors use on-board microprocessors to provide many valuable benefits that are not possible with standard analog sensors. Robust digital signal, advanced predictive diagnostics and Plug and Measure measurement points startup are all features of ISM. Digital ISM technology combined with our many decades' experience in producing hand-blown glass pH sensors results in reliable, high-performance probes for applications across the process industries. See in the video how competence, precision and quality all play their role in just some of the many stages involved in producing sensors.
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Original Publication Date: 06/19/2017

This short animated video briefly explains what pH is and how a pH sensor works. pH is a numerical representation of the hydrogen ion concentration of a liquid. The pH scale runs from 1 to 14, where 7 is neutral, below 7 is acidic (the liquid contains an excess of hydronium ions) and above 7 is alkaline (the liquid contains an excess of hydroxyl ions). Wine, with a pH of 3-4, is therefore acidic; while soapy water, with a pH of 10, is alkaline. pH sensors have a number of elements that are required for them to measure the pH of a solution. The most important part of a pH sensor is the end which is in contact with the liquid. The glass tip is a type of membrane on which a gel layer forms when the sensor is in an aqueous solution. A similar gel layer also forms on the inside of the membrane glass, since the electrode is filled with an aqueous electrolyte solution (a buffer). The hydrogen ions in and around the gel layer can either diffuse into or out of this layer, depending on the pH value and therefore the hydrogen ion concentration of the liquid. This causes a potential to build up on the outside of the glass. The sensor's inner buffer has a constant pH value; therefore, the potential on the inner surface of the membrane remains the same during the measurement. The pH electrode potential, and hence the pH, is therefore the difference between the inner and outer charge of the membrane. Also vital to the function of a pH sensor is the reference electrode. This provides a defined stable reference potential for the pH sensor potential to be measured against. To be able to do this, the reference electrode needs to be made of a glass which is not sensitive to the H+ ions in the solution. It must also be open to the sample environment into which it is dipped. To achieve this, an opening or junction is made in the shaft of the reference electrode through which the inner solution or reference electrolyte is in contact with the sample.
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Original Publication Date: 08/04/2017

Measuring Principle Pressure – absolute/gauge pressure, differential pressure, hydrostatic pressure. With the measuring principle pressure process pressure, differential pressure, level and flow can be determined
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Original Publication Date: 08/04/2014

The BioFlo® 320, next-generation bioprocess control station, is designed as a universal platform capable of meeting the ever changing needs of all segments of the biotech and pharmaceutical sciences. Suitable for microbial fermentation to mammalian cell culture, scale up to scale down, or batch to fed-batch process, the BioFlo 320 has the right combination of features to get the job done, all within an ultra-compact footprint.
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Original Publication Date: 06/30/2015

The Purification process begins as the transfer tank of clarified lysate from the Recovery process is connected to the inlet pump on the Chromatography skid. The first Chromatography step in our GFP purification process is Anion-Exchange. At this point in the process, the pH of the clarified lysate is about eight-point-zero, which means that the protein is negatively charged. Because it is negatively charged, GFP will bind to the positively charged anion exchange resin. The pump draws the lysate from the vessel...past the first conductivity sensor and pressure sensor...and through the zero-point-four-five micron pre-filter. The pre-filter removes any residual cell debris or other particulates that may have contaminated the solution. If the pre-filter begins to clog, the pressure sensor at the inlet side of the filter will register a rising pressure...and the controller will signal the need for a filter change. After pre-filtering and before the column, the lysate passes through a flow meter... and an air sensor. Then, as the lysate passes over the resin beads, the negatively charged protein attaches to the positively charged beads. The solution leaving the column passes a UV optical density sensor, a conductivity sensor and a pH sensor. The optical density sensor's low readings confirm that the GFP is not in the solution, so the outlet valve sends the solution to waste.
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Original Publication Date: 8/5/2014

This video, which has 157,000+ views, explains the dissolution of a solute in a solution.

This video explains the principles and practices associated with aeration and agitation in bioprocessing applications.

This video, which has 2.4+ million views, delivers an informative view of what constitutes a cell.

This video, which has 320,000+ views, explains the process of anaerobic respiration.

This video, which has 15,000+ views, provides a summary of quantitative and qualitative validation cleaning techniques for FDA regulated applications. It includes a Q&A session that provides further insights.

This video, which has 684,000+ views, discusses the basics of steam hammer and its effects.

This video, which has 498,000+ views, discusses the basics of fluid cavitation and its effects.

This video, which has 99,000+ views, explains the structural components and functionalities of a pressure relief valve.

Genzyme is committed to discovering and delivering transformative therapies for patients with rare and special unmet medical needs. With specialized facilities located around the world, Genzyme has particular expertise in manufacturing complex biological medicines. In 2013, with three bioreactors already in commercial production, a fourth bioreactor train at the 2000L-scale Fabrazyme manufacturing facility in Framingham, MA was commissioned. This resulted in a 33% increase in capacity and shortened turnaround to meet bulk intermediate product release timelines. A Review-By-Exception (RBE) program was implemented to reduce manual reviews of batch records by Manufacturing and QA personnel. This reduction was achieved by integrating the Manufacturing Execution System (MES) and DeltaV Distributed Control System (DCS) with the PI System. The automatic transfer of data from the PI Server to MES allowed the batch records to be configured for Review-By-Exception and greatly reduced the number of manual data entries required in the batch records. As a result, the only entries that now require review are manual data entries for critical parameters and flagged event log entries. Since 2014, there have been 38,000+ batch records completed and over 32,000 of these have been automatically reviewed by the system. Since system-reviewed records do not require manual reviews by Manufacturing and QA personnel, this has resulted in savings of over 11,000 man-hours. Secondary benefits realized include time savings in batch record execution, improvements in right-first-time performance of batch record reviews, reduction in non-value added paperwork and associated documentation errors, and reduction in deviations."

This presentation details how Shire has implemented a Global PI system that balances the needs of existing local PI deployments with the strategic needs of accessing data across multiple plants at an Enterprise level. We will share Shire’s long term vision of integrating ERP, MES, and DCS systems alongside the development of standard AF and EF templates to provide a “one stop shop” for consuming applications via Business Integrator.

Founded 30 years ago, Shire is a leading biopharmaceutical company with a focus on rare diseases and other specialty conditions with operational headquarters in Lexington, Massachusetts and Zug, Switzerland. In the pharmaceutical development space, data not only defines products – it is the product. This presentation will give an overview of Shire Pilot Plant Operations, applications of VM architecture, and the use of the PI System as a data integrity tool for increasing researcher productivity. It will also explore a case study from Shire where a number of OSIsoft PI System applications, including Asset Framework, Event Frames, PI Coresight, PI WebParts and Notifications, have been implemented to improve knowledge management in a perfusion cell culture process development environment. Challenges addressed include managing diverse data sources, islands of equipment and instruments, user adaptation to change, and consolidation of multiple network architectures into one secure network for R&D.

The promise of wearables and sensor data for clinical trials includes collecting data that demonstrates new drugs are safe and efficacious and making the trials more efficient, less intrusive and less expensive. The use of devices in clinical trials requires logistics, scientific, biostatistics, health economics and technology expertise. The data generated from wearables must be transferred securely from the wearable sensor while protecting patient privacy. In addition, the data are substantial in terms of frequency and volume and approach “big data” designation. Tools like PI Vision are critical here as the volume of this data requires new approaches to analytics and presentation to users. The science, logistics, data management, visualization and analytics of wearables are still maturing for clinical trials. This presentation will break down the elements of wearables inclusion in clinical trials and the associated storage and visualization via OSIsoft tools.

A key deliverable for the Biologics Development and Biologics Manufacturing Sciences & Technology organizations at Bristol-Myers Squibb is to generate and document process knowledge that will inform the in-process control strategy for existing and/or eventual biologics manufacturing processes. Three years ago, an investment was initiated to improve the process of (1) capturing data and then (2) transforming that data into process knowledge, particularly focused around the laboratory-scale production bioreactor unit operation, so that both organizations are able to deliver on the growing biologics pipeline more quickly, more efficiently, and more consistently. The purpose of this talk is to showcase the result of this investment, the Biologics Analytics Tool, which is a Spotfire visualization serving upstream scientists that seamlessly aggregates and visualizes bioreactor-related data from the PI System with data from an Electronic Laboratory Notebook system and a Laboratory Information Management System. In particular, the talk will focus on how PI Web API and the PI Integrator for Business Analytics were key enabling components that were leveraged to structure the data and then subsequently create the Biologics Analytics Tool.

Currently, Eli Lilly does not have access to real-time data from the contract manufacturers (CM) in their Device Manufacturing group. They rely on the CM to provide reports and/or ad-hoc data. Utilizing Asset Analytics, Event Frames and OSIsoft Cloud Services, Eli Lilly executed a Proof-of-Concept (PoC) to implement a PI System at a Contract Manufacturing site. PI Cloud Connect allowed Lilly to remotely monitor assets on a discrete manufacturing line. This PoC proved to enable an array of benefits, including standardized “Production Monitoring” calculations, categorization of various downtimes, automation of manual reports generated by the CM, compliance (batch reporting) and comparison of machine performance across multiple contract manufacturers, such as machines producing the same parts. Eli Lilly is now working through development and rollout strategies to implement this approach at a number of their contract manufacturers.

The session will introduce a use case where the PI System is used for environmental monitoring in a new research building in Basel, with flexible modular room layouts. Rooms are put together on the fly from cells, and event frames are used to represent the current room layout. There are no fixed visualization displays. Visualizations on wall panels and in the browser are all created automatically based on the dynamic information from the PI System. Visual Analytics are a development of Roche. The system allows to visualize any data and map it on a three dimensional interactive model. In the current project stage the layers "Environmental Monitoring" and "Equipment Tracking" are implemented. As one Data Source for the solution PI interacts with a BIM Plattform connected over the PI to Web Interface.

This case study compares using OSIsoft PI Asset Framework and Event Frames versus manual techniques to aggregate biopharmaceutical batch data and test attributes from disparate data source systems to enable multivariate statistical modeling. The primary objective is comprehensible integration of batch process data with recipe conditions, test results, raw material attributes, and process analytical technology to model the evolution of a batch, including predictive and prescriptive analytics. Various data science methods are achieved by wrapping contextualized time-resolved batch event data for analysis, visualization and reporting. keywords: Interface, asset framework, AF, event frames, EF, data warehousing, link tables, cycle times, PI DataLink, principal components analysis, PCA, partition of variance components, projected latent structures, PLS, batch evolution modeling, SIMCA-online, univariate bivariate and multivariate statistics.

This presentation will outline Biogen’s approach to achieving a strong security posture within our Manufacturing Control Network (MCN). Biogen originally had a restricted network with access to an open data layer network. We rebuilt our system architectures with a focus the S95 network standard and specific rules for data flow. A key to this architecture is putting data in the hands of everyone by replicating all of our PI System data. See the results of our System Connector Beta Test and how it fits into our journey towards a hardened network.

This video, which has 197,000+ views, provides an informal yet informative overview of amino acids.

Protein folding is the continual and universal process whereby the long, coiled strings of amino acids that make up proteins in all living things fold into more complex three-dimensional structures. By understanding how proteins fold, and what structures they are likely to assume in their final form, researchers are then able to move closer to predicting their function.

In deciding which single-use platform to choose, reliability and robustness are fundamental requirements. Beyond process performance, it is important to consider how control systems and automation come into play, how easy it is to implement the platform, and if the design is flexible enough to support varying production volumes.

This week our Two Minute Tuesday educational video is the first in a four part series of interviews with Dr. Shawn Latham, Validation Manager at Shire Plc.. In this video Shawn shares his view on how to maintain the validated state in bioprocessing.

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When all of the eluate has been collected and pooled, it’s time for HIC. Hydrophobic Interaction Chromatography is based on the principle that hydrophobic chemicals on the resin surface will bind to hydrophobic patches on the GFP protein. In order for this to occur, the resin and protein eluate have to be in a high salt environment to remove the water shielding. The salt we use is ammonium sulfate. To remove the attached GFP protein from the HIC column we lower the salt concentration during elution causing the water shielding to reform and the GFP protein detaches from the resin into the elution stream.

The protein-rich eluate is collected and pooled. The product is now ready for the last major step, TFF.

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The GFP fermentation process really begins with the expansion of our bacteria seed stock.

A sample of modified E-coli is taken from the freezer and thawed. It’s used to inoculate a small amount of fresh media in a shaker flask. The media provides the nutrition the cell needs to grow.

When the cells have grown and consumed most of the nutrients, they’re transferred to a larger vessel with more growth media, and the process repeats...This scaling-up is complete when the number of cells is large and healthy enough to transfer into a production vessel – often we call that a bioreactor or fermenter.

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08/05/2014 presents the next technological advancement in Filtration. The KML™ 100 (KrosFlo® MagLev), is a Benchtop Perfusion and TFF System, maximizing convenience and flexibility for Continuous Cell Perfusion and Tangential Flow Filtration. It is ideal for maintaining cell viability, and increasing production of biological drugs, at processing volumes ranging from 2 Liters to 100 Liters. Utilizing modified polyethersulfone membranes, the KML benchtop system creates a conducive environment for cell growth, removing problematic enzymes.
The KML has 5 modes of TFF control, for a variety of concentration and diafiltration recipes. Or, a perfusion mode, tailored to your specific bioreactor’s needs. Spectrum’s unique flow path design provides increased process efficiency, and ensures cell viability. The low shear magnetic levitating pump creates a consistent, gentle flow that eliminates pulsation to protect your sample throughout the automated process.
Additionally, low residence time of cells outside the bioreactor provides the optimal conditions for cell growth. Built-in communication between components keep the KML system constantly up-to-date and in-sync. Automatically controlling pressures, flows, and weights. Maintaining pressures for optimal process flux; matching flow set-points for a consistent consistent RPM’s. All while, balancing the flow rate of media addition and permeate flow.
Simply input your unique specifications ahead of time with Spectrum’s load cell set-point controls. And, let the KML do the rest.
Spectrum’s color touch screen displays real-time data for important process parameters, to ensure product safety, the KML system incorporates visible and audible alarm systems, with safety interlocks during operation. Real-time graphs will collect requested data, eliminating tedious clerical work in the lab. Once completed, USB Data Collection is simple. Ready to go, and available at your finger tips.
The KML’s compact design minimizes your laboratory footprint.
The detachable flow path stand expands your arrangement options and flexibility. Making the KML easily adaptable to any laboratory set-up or style. The KrosFlo MagLev Benchtop System from Spectrum Labs.
Advancing the Science of Separation, and Cell Expansion!

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The Mobius® Single-use Mixing Solution delivers ADVANCED TECHNOLOGY for mixing pharmaceutical ingredients from intermediate to final drug products and for the preparation of process solutions, such as buffers and media.

Set-up of this single-use mixer is EASY and can be accomplished in minutes.

The Mobius® mixer does not require a warm up time, which significantly IMPROVES process turnaround and PRODUCTIVITY.

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What is recombinant adenovirus expression system?
➜ Recombinant Ad expression vectors exploit the high nuclear transfer efficiency and the low pathogenicity of the virus to deliver genes to the host cell. Adenovirus vectors can be used in vaccines where the vector expresses a foreign antigenic protein and adenovirus vectors can be used in gene therapy, where the vector expresses a functional protein to correct a genetic defect.

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