A biological drug is defined as a: …substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological drugs include antibodies, interleukins, and vaccines. The market for...
Author: Michalle Adkins At the March 21-23 Interphex 2017, Emerson exhibitor staff will be discussing three main themes: delivering capital projects on time with lower risk; comprehensive automation solutions for flexible, single-use facilities; and improving...
Author: Jonathan Lustri Manufacturing Execution System (MES) Life Sciences projects can be costly and be a challenge to keep in control. The biggest contributor to these challenges are the defining and design of manufacturing workflows. A Workflow is an MES procedural...
One only has to do a Google image search on pharmaceutical equipment to see the clean, sanitary conditions required for pharmaceutical and biopharmaceutical processing. The measurement instrumentation must be able to handle the tough conditions when cleaning and...
The integrity of the data behind the production of pharmaceutical products is paramount. In recent years, the U.S. Food & Drug Administration (FDA) has increasingly observed data integrity related Current Good Manufacturing Practices (CGMP) violations during CGMP...
The pharmaceutical and biopharmaceutical industries have been interpreting recent FDA draft guidance—Data Integrity and Compliance With CGMP Guidance—and exploring new areas such as continuous manufacturing. The Emerson Life Sciences team has a full program of forums,...
One of the trends in the biopharmaceutical industries that have taken root over the past decade and a half is the use of single-use, disposable equipment in the manufacturing process. Prior to their use, these facilities relied on inflexible, hard-piped equipment. An...
For pharmaceutical and biotech manufacturers, trends in the market place are driving changes in the way they have historically operated their production processes. I caught up with Emerson's Michalle Adkins who shared these trends with me. She identified six major...
Author: Michalle Adkins In April 2016, the FDA issued Data Integrity and Compliance With CGMP Guidance for Industry. This is on the heels of a lot of related 483s, warning letters, and more severe actions with respect to this issue. There are some interesting things...
Author: Jonathan Lustri I recently worked on a Syncade manufacturing execution system (MES) project where the system was deployed in Danish. Emerson executes all its projects with a global team and this one was no different. Our customer was Danish and we had team...
A Pharmaceutical Manufacturing magazine study revealed that pharmaceutical and biotech manufacturers were challenged to achieve batch after batch repeatability. I came across a recently published whitepaper, Consistency and Repeatability Through Accurate Measurements....
Why is there a movement in the pharmaceutical and biotech manufacturing industries to consider continuous manufacturing over traditional batch manufacturing processes? A 2012 U.S. Food & Drug Administration presentation, FDA Perspective on Continuous...
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This blog features expert perspectives from Emerson's automation professionals on industry trends, technologies, and best practices. The information shared here is intended to inform and educate our global community of users and partners.