Activity
  • Biopharmaceutical Models in Development and Production

    Bob Lenich Models of manufacturing and production processes can provide value through the lifecycle of these facilities, from up front design through ongoing personnel training and optimization. One quick example is the simulation used to test out the control strategies before commissioning the control system. In a BioPharm International article, Biopharma modeling, now and five years from now , Emerson’s Bob Lenich…
  • Real-Time Adaptive Scheduling in Life Science Manufacturing

    Pharmaceutical & Biopharmaceutical manufacturers face the continued challenge of how to achieve maximum capacity in their facilities. Often a facility does not achieve maximum design capacity due to hidden operational bottlenecks. One way to drive performance gains is to identify the causes behind this situation and operate as close to design specifications as is possible. At the Biomanufacturing World Summit, Emerson…
  • Biopharmaceutical Product and Process Knowledge Management

    The American Productivity & Quality Center (APQC) , a world-leading authority in knowledge management (KM), defines KM: The application of a structured process to help information and knowledge flow to the right people at the right time so they can act more efficiently and effectively to find, understand, share, and use knowledge to create value. For biopharmaceutical producers, creating value from the knowledge capture…
  • Sharing Best Practices on Path to Pharma 4.0

    Pharma 4.0 is an initiative based on Industry 4.0, begun out of the International Society for Pharmaceutical Engineering Germany/Austria/Switzerland (ISPE D/A/CH) organization, which lead to the formation of : …the ISPE Pharma 4.0 special interest group (SIG) in 2017. Pharma 4.0 envisions highly efficient automated processes—which could be continuous, batch, or a hybrid of these—driven by an integrated manufacturing…
  • Predictive and Prescriptive Maintenance in Life Sciences

    When you think of machinery for industrial use, often images of refineries, oil & gas production sites and other visual images come to mind. But what about the machinery and other equipment in industries with shiny stainless steel everywhere, such as pharmaceutical, biotech and food & beverage manufacturing? Dennis Belanger The pumps, fans, and other pieces of process equipment must operate reliably and be part of…
  • Innovating to Meet Bioprocessing Single-Use Requirements

    Manufacturing in the biotech industry has been undergoing many changes. An ADC Review article, Emerging Trends in Single-Use Technology in the Manufacturing of Antibody-Drug Conjugates , highlighted one of these trends: First introduced in the late 1970s in the form of disposable capsules and a range of filters, single-use technologies were revolutionized in the late 2000s with the introduction of single-use 2D and…
  • Biomanufacturing Fluidic System Single-Use Technologies

    Mukta Sharma As medicines and therapies become more specialized for individuals, the requirements of biopharmaceutical manufacturing processes are dramatically changing, especially in the transition from large-scale to single-use production processes. In a Processing magazine article, Process Control Automation Systems Maximize Biomanufacturing Agility in Single-Use Applications , Emerson’s Mukta Sharma highlights…
  • Sensors for Single-Use Bioreactors

    Michael Francis For pharmaceutical and biopharmaceutical manufacturers, scaling up production has typically meant large, 5000+ liter stainless steel bioreactors for the process. These require cleaning and sterilization between batches. Market demands are driving the need for more flexibility with smaller batches. Single-use technologies (SUT) are being applied to bioreactors to address these demands and reduce the cost…
  • Optimizing Biomanufacturing in Real Time

    One of the inherent challenges in top-down scheduling systems, such as manufacturing plans generated from Enterprise Resource Planning (ERP) systems (Level 4 in ANSI/ISA-95 model ), are that they are typically based on the ideal state of manufacturers’ processes. The real state may quite different and include issues with equipment, processing steps that didn’t go as planned, and other less-than-ideal occurrences. For…
  • Taming Big Data in the Life Sciences

    Bob Lenich The Interphex conference for pharmaceutical and biotech manufacturers is underway this week in New York City. Emerson’s Bob Lenich is presenting Big Data in Life Sciences Manufacturing. Bob opens citing one pharmaceutical manufacturer who generates 5000 data points every second during a production run. This data rate translates into 1.3*10 10 pieces of data per production run. Here are some of the data…
  • BioPhorum Roadmap for In-line Monitoring and Real-time Release

    Professionals across the Life Sciences industry are gathering this week in New York City for Interphex . Organizers bill this conference as: …the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can “Experience Science through Commercialization”. Michalle Adkins Emerson’s Michalle Adkins will be presenting, Update on BioPhorum’s Roadmap for In-line Monitoring and Real…
  • Advancing Digital Plant Maturity for Biopharmaceutical Manufacturers

    Ron Rossbach At the recent 2019 China International Biopharma4.0 Summit , Emerson’s Ron Rossbach presented Biopharma 4.0—Integrated Software Enabling Digital Capabilities. I’ll highlight some of Ron’s key points. He opened describing some of the main challenges biopharmaceutical manufacturers seek to address through enterprise digitalization—reducing time to market, increasing capital expenditure (CAPEX) productivity…
  • Manufacturing Execution Systems in Drug Research and Development

    The U.S. Food & Drug Administration (FDA) outlines the drug development process in five steps: Discovery and development Preclinical research Clinical trials FDA review FDA post-market safety monitoring Zuwei Jin I caught up with Emerson’s Zuwei Jin whom you may recall from earlier posts on the role of automation in the drug development process . Zuwei explained to me how manufacturing execution systems…
  • Manufacturing Execution Systems in Drug Research and Development

    The U.S. Food & Drug Administration (FDA) outlines the drug development process in five steps: Discovery and development Preclinical research Clinical trials FDA review FDA post-market safety monitoring Zuwei Jin I caught up with Emerson’s Zuwei Jin whom you may recall from earlier posts on the role of automation in the drug development process . Zuwei explained to me how manufacturing execution systems…
  • Biopharmaceutical Single Use Measurement and Control

    A recent Biopharm International article, Single-Use Bioprocessing Equipment Trends and Adoption by CMOs highlighted this trend: Single-use systems (SUS)—bioprocessing equipment designed for one-time use or a single product manufacturing campaign—has become the leading paradigm for pre-commercial (preclinical and clinical supplies) manufacturing of biopharmaceutical products ( 1 ). At this past autumn’s Emerson…
  • Biopharmaceutical Single Use Measurement and Control

    A recent Biopharm International article, Single-Use Bioprocessing Equipment Trends and Adoption by CMOs highlighted this trend: Single-use systems (SUS)—bioprocessing equipment designed for one-time use or a single product manufacturing campaign—has become the leading paradigm for pre-commercial (preclinical and clinical supplies) manufacturing of biopharmaceutical products ( 1 ). At this past autumn’s Emerson Exchange…
  • Fostering Organizational Collaboration in the Life Sciences

    As automation technologies continue to incorporate commercial off the shelf technologies and cybersecurity concerns grow, the need for manufacturers’ Information Technology (IT), Operational Technology (OT) and Quality teams to collaborate grows. In a PharmTech article, Improving Production: How IT, OT, and Quality Can Collaborate , Emerson’s Will Goetz and Ron Rossbach describe how the different groups must work together…
  • Fostering Organizational Collaboration in the Life Sciences

    As automation technologies continue to incorporate commercial off the shelf technologies and cybersecurity concerns grow, the need for manufacturers’ Information Technology (IT), Operational Technology (OT) and Quality teams to collaborate grows. In a PharmTech article, Improving Production: How IT, OT, and Quality Can Collaborate , Emerson’s Will Goetz and Ron Rossbach describe how the different groups must work together…
  • Outlook and Trends for Biotech Industry

    What is the 2019 outlook for research & development in the biotech industry? Pharmaceutical Processing magazine explores this question in an article, Outlook 2019: Tech, Data, and Biotech Boom . Emerson’s Bob Lenich joined other suppliers to this industry to share his thoughts on some of the issues, challenges and developments expected to occur in the coming year. On the question of market trends, Bob shared: …
  • Outlook and Trends for Biotech Industry

    What is the 2019 outlook for research & development in the biotech industry? Pharmaceutical Processing magazine explores this question in an article, Outlook 2019: Tech, Data, and Biotech Boom . Emerson’s Bob Lenich joined other suppliers to this industry to share his thoughts on some of the issues, challenges and developments expected to occur in the coming year. On the question of market trends, Bob shared: …
  • Tracking Cell Therapy Chain of Identity

    Cell therapy is when: …cellular material is injected into a patient; [1] this generally means intact, living cells . For example, T cells capable of fighting cancer cells via cell-mediated immunity may be injected in the course of immunotherapy . For manufacturers in the Life Sciences industry, making these therapies poses challenges since each batch is specific to a given patient. In this 2:25 YouTube video…
  • Tracking Cell Therapy Chain of Identity

    Cell therapy is when: …cellular material is injected into a patient; [1] this generally means intact, living cells . For example, T cells capable of fighting cancer cells via cell-mediated immunity may be injected in the course of immunotherapy . For manufacturers in the Life Sciences industry, making these therapies poses challenges since each batch is specific to a given patient. In this 2:25 YouTube video…
  • Life Sciences at Emerson Exchange

    Author: Michalle Adkins Emerson Exchange begins in just a few short days. I am quite excited about the Life Sciences relevant content in the exhibit hall this year. We are covering many different technologies including instrumentation, controls, batch processing, process analytical technology integration, manufacturing execution systems (MES), analytics, virtual reality, augmented reality, IIOT, and more. We will…
  • Life Sciences at Emerson Exchange

    Author: Michalle Adkins Emerson Exchange begins in just a few short days. I am quite excited about the Life Sciences relevant content in the exhibit hall this year. We are covering many different technologies including instrumentation, controls, batch processing, process analytical technology integration, manufacturing execution systems (MES), analytics, virtual reality, augmented reality, IIOT, and more. We will…
  • Best Practice for MES-SAP interface Factory Acceptance Testing

    Author: Jonathan Lustri Almost all Life Sciences manufacturing execution system (MES) projects include an interface to SAP, the enterprise resource management system . This interface is strategic in that this is how the business and production are tied together. It allows the manufacturing floor to be integrated with the business for cost accounting, material planning, and production planning. The integration transactions…