Activity
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...
    • 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...