The pharmaceutical and biopharmaceutical industries have been interpreting recent FDA draft guidance—Data Integrity and Compliance With CGMP Guidance—and exploring new areas such as continuous manufacturing.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,...
How many of you have more passwords than you can possibly remember? Count me in with the affirmatives. Biometric authentication is one way to overcome this large and growing problem. For process manufacturers and producers, especially those in highly regulated...
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 We are seeing a trend in the life sciences industry moving away from blockbusters to niche busters, population based medicines and even to the extreme of personalized medicines. The Emerson Life Sciences consulting team recently had the...
For pharmaceutical and biopharmaceutical manufacturers, there are a lot confusion around the concepts of design space (DS), Process Analytical Technology (PAT), and Quality by Design (QbD). Emerson's Zuwei Jin believes that this confusion has largely limited the...
The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and...
The Emerson Exchange conference October 6-10 in Orlando, Florida USA is rapidly approaching. I caught up with Emerson's Michalle Adkins who mentioned that her team of Life Sciences consultants would be highlighting the enablement of release by exception. Although...
In 2011, the U.S. Food & Drug Administration (FDA) published their Guidance for Industry – Process Validation: General Principles and Practices. A PharmManufacturing.com article, A Framework for Technology Transfer to Satisfy the Requirements of the New Process...
In the 4:42 video, Life Science Drug Process Development and Manufacturing, Emerson's Gary Mitchell highlights the changes occurring for pharmaceutical and biotech manufacturers. Gary opens noting how these manufacturers are challenged to respond to new methods for...
Author: Michalle Adkins I often get asked, "So, what do you do for a living?" Boy is that a loaded question. When I say that I manage a group of Life Sciences Industry Consultants for Emerson—that really does not help to answer the question. Hmmm, how do I describe...
This week, the Bio International Convention (Bio 2014) is happening in San Diego, California. Several of Emerson's Life Sciences consultants, including Zuwei Jin, are there to discuss some of the issues and trends in pharmaceutical and biotech manufacturing processes...
Author: Gary Mitchell The Emerson Life Sciences Industry Solutions Group consultants, including Saroj Patnaik, Michalle Adkins, Jonathan Lustri, Zuwei Jin and me, will be joining Hillary Clinton, Sir Richard Branson and over 15,000 other attendees from Biotech and...
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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.