Emerson Exchange 365

Activity

Manufacturing Execution Systems in Drug Research and Development

Jim Cahill

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

Jim Cahill

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
Biopharmaceutical Single Use Measurement and Control

Jim Cahill

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…
- 21 Jan 2019
Biopharmaceutical Single Use Measurement and Control

Jim Cahill

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…
- 18 Jan 2019
Fostering Organizational Collaboration in the Life Sciences

Jim Cahill

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…
- 11 Jan 2019
Fostering Organizational Collaboration in the Life Sciences

Jim Cahill

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…
- 11 Jan 2019
Outlook and Trends for Biotech Industry

Jim Cahill

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

Jim Cahill

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
Tracking Cell Therapy Chain of Identity

Jim Cahill

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

Jim Cahill

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
Life Sciences at Emerson Exchange

Jim Cahill

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

Jim Cahill

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
Best Practice for MES-SAP interface Factory Acceptance Testing

Jim Cahill

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…
- 24 Sep 2018
Best Practices for Implementing a Process Control Driven MES System

Jim Cahill

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
Advancing Innovation in Pharmaceutical and Biologics Manufacturing

Jim Cahill

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…
- 13 Aug 2018
IIoT in the Life Sciences Industry

Jim Cahill

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…
- 3 Jul 2018
Optimizing Media Flow in Biologics Manufacturing

Jim Cahill

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…
- 11 Jun 2018
Moving to Electronic Batch Records

Jim Cahill

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
Improving Batch Manufacturing Quality Review Cycle Time

Jim Cahill

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
Tech Transfer in Drug Development Pipeline and Industry 4.0

Jim Cahill

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 a…
- 22 May 2018
Technology Trends for Life Sciences Manufacturers

Jim Cahill

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…
- 17 Apr 2018
Data Integrity for Pharmaceutical and Biotech Manufacturers

Jim Cahill

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

Jim Cahill

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…
- 13 Mar 2018
Identify and Resolve Cell Therapy Batch Manufacturing Exceptions

Jim Cahill

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

Jim Cahill

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