• Blog

    • 120 posts
    • Updated 25 days ago
Activity
    • 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...
    • 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...
    • 17 Apr 2018

    Technology Trends for Life Sciences Manufacturers

    We seem to be fully in the swing of industry conferences. This week is the pharmaceutical and biotech manufacturing industries’ INTERPHEX conference in New York City. It: …brings over 11,000 global industry professionals and 650+ leading suppliers together to “Learn It, Experience It, Procure It” through a combination of no cost technical conference, exhibits, demonstrations, and networking events to leverage quality...
    • 13 Mar 2018

    Data Integrity for Pharmaceutical and Biotech Manufacturers

    Update: This post has been updated with a link to the most recent Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions – March 2018 document. For pharmaceutical, biotech and other manufacturers in highly-regulated industries, the production data is as important as the product itself for release to sale. Data integrity of this production data is paramount. I connected...
    • 13 Mar 2018

    Data Integrity for Pharmaceutical and Biotech Manufacturers

    For pharmaceutical, biotech and other manufacturers in highly-regulated industries, the production data is as important as the product itself for release to sale. Data integrity of this production data is paramount. I connected with Emerson’s Michalle Adkins about what manufacturers are doing to assure this data is accurate and timely. She shared with me some key regulatory standards and best practices. Michalle...
    • 20 Feb 2018

    Identify and Resolve Cell Therapy Batch Manufacturing Exceptions

    We conclude our series on improving cell therapy manufacturing with a closer look at the review by exception process. In the manufacturing process of cell therapeutics, product cycle times are extremely short and any exceptions occurring during the production process must be found and addressed quickly. Emerson’s Bob Schiros notes that manufacturing execution systems, such as the Syncade MES , must include this...
    • 20 Feb 2018

    Identify and Resolve Cell Therapy Batch Manufacturing Exceptions

    We conclude our series on improving cell therapy manufacturing with a closer look at the review by exception process. In the manufacturing process of cell therapeutics, product cycle times are extremely short and any exceptions occurring during the production process must be found and addressed quickly. Emerson’s Bob Schiros notes that manufacturing execution systems, such as the Syncade MES , must include this...
    • 13 Feb 2018

    Increasing Autoclave Reliability via Machine Learning Technology

    ARC Advisory Group’s Paula Hollywood moderated a session, IT/OT/ET Convergence at the 2018 ARC Industry Forum. Here’s the description from this session: The convergence of IT (Information Technology at the enterprise level) and OT (Operations Technology, the information and automation technologies employed in the plant), is not new, but the relationship is intensifying. What is changing is the addition of ET (Engineering...
    • 7 Feb 2018

    Designing and Building Pharmaceutical and Biotech Smart Factories

    Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing functionality representing the best practice in the industry and complying with the regulation such as cGMP. The smart factory technology connects the plant digitally...
    • 2 Feb 2018

    Digital Transformation to Paperless Production

    Manufacturing processes have long been paper-based with log entries, initialing, signoffs and other transactions to manually record. While automation systems have captured some of this manual recordkeeping, they have not been able to capture everything. In batch manufacturing processes that produce thousands of batches each year, maintaining paper records for each batch is a time-consuming, error-prone, and costly...
    • 18 Jan 2018

    Reducing Execution Errors in Cell Therapeutics Manufacturing

    In an earlier post, Managing the Chain of Identity in Cell Therapeutics Manufacturing , we highlighted how the manufacturing process of these cell therapies must be performed with absolute accuracy the first time since each batch is produced for a specific patient. It’s critical during the production process that any execution errors be identified and corrected before completion. Any errors in development, manufacturing...
    • 17 Jan 2018

    Digital Twin for Increased Project and Operational Performance

    You may have been seeing the phrase “Digital Twin” more and more in the automation and industry press. Wikipedia defines the Digital twin concept as: …a digital replica of physical assets, processes and systems that can be used for various purposes. [1] The digital representation provides both the elements and the dynamics of how an Internet of Things device operates and lives throughout its life cycle. [2] ...
    • 4 Jan 2018

    Managing the Chain of Identity in Cell Therapeutics Manufacturing

    Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as : …the transplantation of human or animal cells to replace or repair damaged tissue. From a manufacturing perspective, each therapeutic batch must be perfect the first time — because each batch is produced for a specific patient. The next unique batch, for...
    • 4 Jan 2018

    Managing the Chain of Identity in Cell Therapeutics Manufacturing

    Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as : …the transplantation of human or animal cells to replace or repair damaged tissue. From a manufacturing perspective, each therapeutic batch must be perfect the first time — because each batch is produced for a specific patient. The next unique batch, for...
    • 31 Oct 2017

    Successfully Implementing Process Analytical Technology

    It’s been well more than a decade since the U.S. Food & Drug Administration (FDA) announced a Process Analytical Technology (PAT) approach for pharmaceutical manufacturers in their Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance . While conceptually understandable, it has taken time for PAT to be put into practice in an effective way. In an ISA...
    • 11 Oct 2017

    Integrating Analytics Across Process Development Lifecycle

    For batch processes found in industries such as pharmaceutical & biopharmaceutical, food & beverage, specialty chemicals, etc., analytics technology advancements are helping to improve quality, consistency and reliability. I caught up with Emerson’s Zuwei Jin for an update on these advancements and how they are being applied. He put together a chart of the process analytics landscape. The orange lines indicate the...