Activity

  • Integrated Biometric Authentication in Electronic Records

    Jim Cahill
    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 industries such as pharmaceutical and biopharmaceutical manufacturing, authenticated actions also need to be recorded to prove that the manufacturing process was…

  • Trends in the Life Sciences Industry

    Jim Cahill
    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 areas: continuous manufacturing, single use technology, biosimilars & generics, personalized medicine, demographic shifts, and taking advantage of emerging…

  • FDA Guidance for Data Integrity and Compliance

    Jim Cahill
    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 to note from this document. The FDA has provided this document based on their duty to protect the public health. Generally speaking, data must be reliable…

  • Deploying Syncade Manufacturing Execution System in a Non-English Language

    Jim Cahill
    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 members from Denmark, the US, India, Romania, England, and France. In a project like this, a single language must be selected for system design and the only…

  • Continued Process Verification through Process Validation Stage 1, 2 and 3

    Jim Cahill
    For pharmaceutical and biotech manufacturers, Continued Process Verification is: …the collection and analysis of end-to-end production components and processes data to ensure process is running under the state of control and product outputs are within predetermined quality limits. In an earlier post, Online Multivariate Data Analysis for Continued Process Verification , we mentioned a new approach for performing…

  • Accurate and Repeatable Measurements in Pharmaceutical and Biotech Manufacturing

    Jim Cahill
    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 . Emerson’s Michalle Adkins played a role in its contents. The whitepaper highlights: …how reliable, accurate instrumentation allows automation to…

  • Overcoming Pharmaceutical Continuous Manufacturing Challenges

    Jim Cahill
    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 Manufacturing , captured some of the reasons why. Author Dr. Sharmista Chatterjee listed some advantages: Integrated processing with fewer steps No manual handling…

  • Batch Repeatability through Instrument Performance and Diagnostics

    Jim Cahill
    Author: Kyle Knutson Batch repeatability is critical in pharmaceutical and biotech manufacturing. Variations between batches that cause deviations require extensive analysis, either in real-time or post-process, to identify how to control and minimize this variation in the future. The consequences of unacceptable batch variation can be anything from extensive maintenance hours, to temporary halts in production or…

  • Life Experiences Shape Consulting Translation Skills

    Jim Cahill
    Author: Michalle Adkins Before the holidays, I wrote a blog post, Life Experiences from a Woman in STEM, in the Emerson Exchange 365 Women in Stem group. I talked about growing up on a farm where I gained some early experiences with animals, vitamins, medications, pumps, controllers, and valves. I don’t think I realized it at the time, but this coupled with my high school math teacher’s encouragement to go into…

  • Repeating Golden Batch Production

    Jim Cahill
    For batch-based processes, the “golden batch” is term often used to describe the ideal batch against which all other batches are compared. In a Control magazine article, Data Analytics in Batch Operations , it is defined: …as the time-based profile of the measurement values that were recorded for a particular batch that met product quality targets. When using this standard, a batch is judge by how closely the golden…

  • Is Process Analytical Technology Rocket Science?

    Jim Cahill
    More than a decade ago, the U.S. Food and Drug Administration published, Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance . In this document, the FDA explained: The scientific, risk-based framework outlined in this guidance, Process Analytical Technology or PAT, is intended to support innovation and efficiency in pharmaceutical development, manufacturing…

  • Online Multivariate Data Analysis for Continued Process Verification

    Jim Cahill
    Measuring quality in real-time improves the overall performance of a manufacturing process. The International Foundation Process Analytical Chemistry (IFPAC) is: …a world-wide, not-for-profit organization dedicated to the advancement of Process Analytical Technology and Chemistry. They are holding the IFPAC Annual Meeting later this month in the Washington D.C. area. This meeting provides a forum for discussions…

  • Niche-Buster Medicine Information Solutions

    Jim Cahill
    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 opportunity to work with one of these emerging companies that is using a novel process that genetically engineers each patient’s own T cells to recognize and…

  • Develop, Test and Train for Lower Risk Projects

    Jim Cahill
    One way to improve the probability for a successful process automation project is to include dynamic simulation during the design phases to help with configuring the control system, testing before commissioning the system and training the operators before the process goes live. In an earlier post, Building Competency through Operator Training Systems , we highlighted the application of operator training simulators …

  • Optimizing Batch Process Automation Design in MES and DCS

    Jim Cahill
    For pharmaceutical and biotech manufacturers, the flow and capture of information is as important as the flow of the manufacturing process in readying products to release for sale. In a Pharmaceutical Technology magazine article, Connecting MES to Process Control , Emerson’s Jonathan Lustri is interviewed about advances in using the ISA-88 standard to coordinate manufacturing execution systems (MES) and distributed…

  • Improving Data Management, Analytics and Flexibility in Life Sciences

    Jim Cahill
    Pharmaceutical and biopharmaceutical manufacturers are challenged on many fronts, such as managing regulatory requirements, operating efficiency, and maintaining the right data required as part of the medicines and products produced. Emerson’s Michalle Adkins was recently at a Life Science Symposium Update session in Europe attended by more than 50 pharmaceutical and biotech company representatives. This symposium addressed…

  • Solving Reactor Temperature Control Challenges

    Jim Cahill
    Some of my favorite posts are ones that come out of a string of problem-solving email messages. And so it is with today’s post. Emerson’s Mark Coughran was recently at biopharmaceutical facility that was having temperature control issues on a reactor vessel. The temperature process variable was overshooting far past the setpoint with the control loop output failing to reverse this overshoot in a timely way. When it…

  • US FDA Quality Metrics Guidelines Update

    Jim Cahill
    Author: Eric Kuebler Since the Continued Process Verification (CPV) guidance in 2011, the U.S. Food and Drug Administration (FDA) has been talking quality and verifying process state of control. Now the FDA is getting around to defining what that looks like and what data they want to verify quality. However, the FDA’s push is leaving more questions than answers about what specific date they need, how they will use…

  • Optimizing Life Sciences Processes by Improving Data Integration

    Jim Cahill
    Pharmaceutical and biotech manufacturers face many economic and technical challenges including reduced prices and diminishing profits, rising research & development costs, increasing regulatory requirements and a greater need for optimized manufacturing operations. In a Pharma Bio World article, Data Integration Challenges and Solutions for Life Science Industry , Emerson’s Michalle Adkins and Ritesh Patil describe…

  • Data Integrity for Compliance, Audit Readiness and Performance

    Jim Cahill
    Pharmaceutical and biotech manufacturers have stringent regulatory compliance requirements. These requirements must balance with the need for improvement and optimization to run safely, efficiently, profitably and in line with the business and quality objectives. In a Pharma Bio World article, The Crossroads of Compliance, Audit Readiness, Profitability, and Data Integrity , Emerson’s Michalle Adkins opens: True…

  • Conference Room Pilots to Generate Involvement in MES Projects

    Jim Cahill
    Author: Jonathan Lustri As a Life Sciences consultant , I get involved in many different aspects of MES [manufacturing execution system] projects. In a recent project, I helped define the project execution plan. I knew Emerson’s biotech customer was highly concerned about the overall usability of the solution design as well as the acceptance of the solution by the operators. In this particular case, the Syncade…

  • Advancing the Management of Data through Life Sciences Product Lifecycles

    Jim Cahill
    From a recent Life Sciences symposium, we looked at issues in the advancement of process intelligence and analytics . Today we’ll look at another work session from the symposium, Managing Data Through the Product Life Cycle. The general session was led by Amgen’s Harmik Begi and Emerson’s Michalle Adkins . The focus of the team addressing these challenges were to explore the end-to-end value chain of product lifecycle…

  • Advancing Process Intelligence and Analytics in Life Sciences

    Jim Cahill
    In a recent post, Collaborating for End-to-End Supply Chain Improvements , we highlighted a Life Sciences symposium where challenges to business improvements were discussed as inputs for technology and solution innovation to address these challenges. One of the sessions focused on the needs for process intelligence and analytics for pharmaceutical and biopharmaceutical manufacturers. The topic team included leaders…

  • Collaborating for End-to-End Supply Chain Improvements

    Jim Cahill
    You can hardly connect online without coming across articles about big data . Businesses are grappling with how to use this information to improve their businesses—from upfront marketing and sales through improving the efficiency of the supply chain and optimizing lifecycle support. Emerson’s Jonathan Lustri shared background with me of how he is collaborating with a cross section of pharmaceutical and biopharmaceutical…

  • Clarifying Design Space, Process Analytical Technology and Quality by Design

    Jim Cahill
    The post Clarifying Design Space, Process Analytical Technology and Quality by Design appeared first on the Emerson Process Experts blog. 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). Zuwei Jin Senior Life Sciences Consultant Emerson’s Zuwei Jin believes that this confusion…

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