• Blog

    • 134 posts
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    • 22 Aug 2019

    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...
    • 24 Apr 2019

    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...
    • 3 Apr 2019

    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...
    • 1 Apr 2019

    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...
    • 28 Mar 2019

    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...
    • 13 Feb 2019

    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...
    • 13 Feb 2019

    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...
    • 21 Jan 2019

    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...
    • 18 Jan 2019

    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...
    • 11 Jan 2019

    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...
    • 11 Jan 2019

    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...
    • 14 Nov 2018

    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: ...
    • 14 Nov 2018

    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: ...
    • 5 Nov 2018

    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...
    • 5 Nov 2018

    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...
    • 28 Sep 2018

    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...
    • 28 Sep 2018

    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...
    • 24 Sep 2018

    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...
    • 21 Aug 2018

    Best Practices for Implementing a Process Control Driven MES System

    Author: Jonathan Lustri I have previously been interviewed and written about a process control and MES [ Manufacturing Execution Systems ] architecture where the batch control logic within the process control system is the single procedural engine. It drives procedural logic and workflows executed by the MES system when called by the process control system. The benefit of this architecture is an overall lower cost...
    • 13 Aug 2018

    Advancing Innovation in Pharmaceutical and Biologics Manufacturing

    In a U.S. Food and Drug Administration’s FDA Voice blog post, FDA Budget Matters: Investing in Advanced Domestic Manufacturing , FDA Commissioner Dr. Scott Gottlieb opened noting: Advanced manufacturing, which includes various technologies, such as continuous manufacturing and 3D printing, holds great promise for improving the American market for drugs and biologicals. Emerson’s Ron Rossbach shared his thoughts...
    • 3 Jul 2018

    IIoT in the Life Sciences Industry

    When it comes to benefitting from new technologies, pharmaceutical and biotech manufacturers often feel constrained from implementing changes due to possible revalidation regulatory requirements. In this short 1:52 video, Industry 4.0 in Life Sciences , Emerson’s John Nita explains how technologies such as Industrial Internet of Things (IIoT) technologies have actually been around longer than the phrase describing...
    • 11 Jun 2018

    Optimizing Media Flow in Biologics Manufacturing

    Author: Emily Anderson Flexible facilities are a growing trend in the biopharmaceutical manufacturing industry. Manufacturers increasingly look to produce multiple products and maximize production time. To meet these requirements, an automation strategy must maximize the flexibility of the process equipment. The preparation, storage, and distribution of media often requires real-time flowpath selection and bumpless...
    • 30 May 2018

    Moving to Electronic Batch Records

    Yesterday we highlighted advancements in exception management technology for pharmaceutical and biopharmaceutical manufacturers. Exception management is one element in an electronic batch record (EBR) . Other elements for the EBR which also have high data integrity requirements include equipment management, material management and batch record process flow and recipe management. In a PharmTech article, Making the...
    • 29 May 2018

    Improving Batch Manufacturing Quality Review Cycle Time

    Exceptions in batch manufacturing processes are the deviations that occur outside the prescribed specifications. For pharmaceutical and biopharmaceutical manufacturers, quality and manufacturing personnel must review these exceptions. Traditionally, this quality review process occurs after the batch has completed. A recent news release, Emerson Helps Life Sciences Companies Reduce Time to Market with Faster Quality...
    • 22 May 2018

    Tech Transfer in Drug Development Pipeline and Industry 4.0

    Author: Zuwei Jin Among all of the important trends in life sciences industry such as modular plants, integrated modules, out-of-box smart factory, single-use equipment, PAT, and manufacturing execution systems (MES) , IIOT has been receiving high interest including among pharmaceutical and biotech manufacturers. It is our view that the same technology advancement that makes Industry 4.0 possible will lead to...