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  • BioPhorum Cell and Gene Therapy Personas and User Stories

    Earlier I featured two recent BioPhorum publications in these posts: BioPhorum MES of the Future BioPhorum Cell and Gene Therapy Actors and Process Maps Today, I’ll highlight the third and final publication, CGT Personas and User Stories , from this release of publications. As with the other two, Emerson’s Sean Buckley was one of the primary authors, along with others from Cytiva, Dassault Systems, Novartis…
  • Shorten the Equipment Validation Process to Bring Projects Online Faster

    One of the key stages delaying and increasing costs in life sciences projects is equipment validation. In fact, it is one of the elements of project completion that project teams are most eager to compress because the value of every incremental improvement is so great. As Michalle Adkins explains in her recent article in Pharma Manufacturing , “Ultimately, the total cost and time of the full validation process can be…
  • BioPhorum Cell and Gene Therapy Actors and Process Maps

    A few weeks ago I highlighted one of the three new BioPhorum publications, MES of the Future Manifesto . Today, I’ll highlight a second one, CGT [cell & gene therapy] Actors and Process Maps . Emerson’s Sean Buckley was one of the authors along with co-authors from Roche, Takeda, and BioPhorum. Contributions were made during this Cell and Gene Therapy workstream from numerous biopharmaceutical manufacturers and software…
  • Is the Biotech Industry Growing?

    In the biotech realm, many struggle to find experienced and technically savvy providers who can provide unique solutions in control automation. As trends accelerate in the biopharmaceutical industry, manufacturers are looking for new and improved approaches to address industry challenges. What role does Emerson play? Explore Emerson’s Single-Use Technologies to learn how Emerson offers control systems that save…
  • BioPhorum MES of the Future

    We’ve highlighted the work of Emerson experts in the Biophorum Operations Group in several posts . Its mission: …is to create environments where the global biopharmaceutical industry can collaborate and accelerate its rate of progress, for the benefit of all. Emerson’s Sean Buckley alerted me to three recently published documents that he helped develop. These documents include: MES of the Future Manifesto CGT…
  • Hygienic Pressure Measurement for Pharmaceutical and Bioprocess Applications

    The tolerance for pharmaceutical and bioprocess manufacturing variations is relatively small to meet the quality requirements of finished medicines and therapeutics. In a Process Instrumentation article, How to ensure reliable pressure transmitter measurement in pharmaceutical applications , Emerson’s Brandon Haschke shares how “Advanced hygienic pressure transmitters can reduce downtime and operating costs thanks to…
  • Overcoming Pharmaceutical and Biotech Manufacturing Challenges

    Recently, the Pharma Manufacturing World Summit was held in Boston. The focus of the conference is to improve: … cost performance while maintaining quality and compliance in the midst of rapidly changing supply chain models among internal and external manufacturing… Emerson’s Christian Berg presented Are We There Yet? Tackling Manufacturing Challenges with the Digital Plant. Christian opened with the idea that tackling…
  • Faster Tech Transfer Unlocks Speed to Market

    The rapid development of the COVID-19 vaccine has created a dramatic shift in the way the public and life sciences organizations view the manufacturing of pharmaceuticals. In a recent Q&A with Pharma Manufacturing , Nathan Pettus , president of Emerson’s process systems and solutions business, shared how a move toward more flexibility and modularity in the industry is cutting tech transfer times to drive improved speed…
  • Adaptable Landscape Components Facilitate Digital Transformation

    The BioPhorum Operations Group (BPOG) established a digital plant maturity model (DPMM) for biopharmaceutical manufacturing to define stages of factory evolution “from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future.” The model gives organizations a common tool for industry comparison and measurement of progress. It also provides a platform to facilitate collaboration…
  • Remote Monitoring Lays the Foundation for Lights-Out Manufacturing

    It isn’t news that the global pandemic upended the way we operate our plants. When social distancing trapped our most valuable personnel outside the facilities we rely on, it suddenly meant finding new ways to get critical work done. But the reality is, those changes would have been coming—albeit less quickly—even without the influence of COVID. Retirements and shortages of experienced workers have been thinning out…
  • Improve Speed to Market with Closed-Loop Process Control using Spectral PAT

    We have witnessed an incredible change the last few years in how life sciences manufacturers deliver treatments . Today’s focus is on fast results, and that means products patients rely on cannot sit on shelves for weeks or months waiting on quality validation. In a recent article in Pharmaceutical Processing World , Emerson’s Bob Lenich and Bruce Greenwald explored a strategy plants are using to digitally transform…
  • Ultrasonic Welding Helps Ramp Up COVID Test Production

    Demand for COVID test kits remain high and challenge manufacturers to maximize their production levels. In a Plastic News article (registration required), Automation suppliers help meet demand for COVID-19 testing kits , Emerson’s Vernon Murray , president of Branson assembly and welding technologies, highlighted the importance of welding technology in driving production efficiency. The article opens noting the production…
  • Regulatory Requirements for Medical Devices Webinar

    There is a new requirement for medical device companies selling into the European market, called the Medical Device Regulation, or MDR. This new regulation places a focus on the supply chain, meaning suppliers in the industry must have a good understanding of the new regulation in order to do business. Problems arise when the supplier fails to take the necessary steps to understand and implement MDR requirements. …
  • Increasing Life Sciences Manufacturing Capacity

    Supply chain disruptions have forced manufacturers and producers across the globe to reexamine how they source raw materials, inventory, produce, and disseminate what they produce. In an Australasian BioTechnology article, Facilities for a Strong Future , Emerson’s Michalle Adkins and Makarand Mujumdar share how pharmaceutical and biotech manufacturers can improve local capacity to meet the needs of the regions in which…
  • Four Pillars for Life Sciences Line and Facility Efficiency

    The overall Line and Facility effectiveness is becoming an increasing area of focus for Life Sciences manufacturers, where they are continually striving to gain the most from all of the available assets and materials. Challenges such as resource bottlenecks, impacts of variability, lack of visibility to production floor schedule changes, and off-line testing limit line and facility efficiencies are all factors that can…
  • Improving Equipment Reliability for Life Sciences Manufacturers

    Reliability of assets used in the manufacturing process is paramount for safe, efficient and effective operations. Unplanned asset failures, improper asset performance, poor maintenance planning, and untimely follow-through can cause shutdowns, under-utilized production equipment, deviations, or material/product losses. I caught up with Emerson’s Ben Arriola on how this applies to operational integrity for pharmaceutical…
  • Holistic Production Readiness Strategy is Key to Operational Success

    Initiating Good Manufacturing Practices (GMP) production operations, whether as part of facility start-up, product changeover, or following a shutdown, requires complex coordination of both logical and physical process controls. Inefficient configuration and qualification practices for automation and information management systems can lead to both start-up delays and productivity losses. A few items among the many to…
  • Single-use pH Sensors in Biopharmaceutical Applications

    As medicines and therapies become more specialized and targeted, the need for single-use measurement technology grows for biopharmaceutical manufacturers. Emerson’s Ben Arriola along with Jinbo Hu teamed up to share more about this trend in a BioProcess International special report, Design and Performance of a New Single-Use pH Sensor with Long Shelf Life and High Stability . In Ben’s article, Introducing the Next-Generation…
  • A More Measured Move to the Pharma Cloud

    There is little doubt that the recent explosion in available cloud technologies has been a boon for manufacturing across a wide array of industries. Pharmaceutical manufacturers are no exception, and organizations are now carefully considering where leveraging cloud technology makes the most sense to improve business and operational success. In his recent article, “Slow Rush to the Cloud” in Pharma Manufacturing, Emerson…
  • Real-time Scheduling and Capacity Analysis Address Manufacturing Challenges

    A friend of mine who works in Life Science manufacturing told me about a cynical wager she and her colleagues made after their 6-person team completed a 5-day marathon production planning and scheduling session. The 6-person cross functional team did everything in good old Excel. “How soon will they have to meet again to re-schedule and rework this excel file?” That happened about 16 months back – in the dark, early…
  • Effective Personnel Drive Operational Integrity

    As consumers of medicinal products of various kinds (vaccines, immunotherapies, tablets, capsules, cell therapies, etc.), we know that although product quality is important, reliable supply is also critical. A reliable supplier of therapeutic goods requires the facilities within its manufacturing supply chain to also be reliable suppliers of their intermediates and products. An important part of being a reliable supplier…
  • Avoid Taking a Successful Reliability Program for Granted by Improving Its Use

    Success must be supported so it can be sustained. As Chris Jensen and H.P. Slater discuss in an article in the July issue of Process Heating , this line of thinking is no less true in predictive maintenance (PdM) than in anything else. Some companies are impressed with the initial savings that PdM programs generate through improved production and lower maintenance costs, but New PdM programs typically identify many…
  • Avoiding Unplanned Downtime in Life Sciences Industry

    For manufacturers in the Life Sciences industry, production challenges often occur in these four areas—production readiness, equipment reliability, personnel effectiveness and facility/line efficiency. In this post, I’ll focus on equipment reliability, and specifically, unplanned downtime. Maintenance Scheduling Click to enlarge Equipment reliability spans several areas—asset performance, line and unit performance…
  • Improve the Flow, then Automate

    Digital technology amplifies process outcomes, both good and bad, by automating standard workflows, completing calculations, and performing repetitive tasks. It provides the ability to capture and analyze process data real-time while leveraging predictive modeling to inform rapid decision making. Once installed and validated, digital technology relentlessly enforces predetermined process standards. It provides valuable…
  • Fast Tracking Adaptable Manufacturing in Life Sciences

    To inoculate people worldwide as soon as vaccines are proven requires the pharmaceutical industry to ramp up quickly to unprecedented volumes of supply. And technology transfer—moving the knowledge about and the ability to produce a vaccine from development to manufacturing—is a primary determinant of how fast it happens. In a presentation at the ACHEMA Pulse virtual conference this year, Emerson’s Alan Johnston shared…