At the recent 2019 China International Biopharma4.0 Summit, Emerson’s Ron Rossbach presented Biopharma 4.0—Integrated Software Enabling Digital Capabilities. I’ll highlight some of Ron’s key points. He opened describing some of the main challenges biopharmaceutical manufacturers seek to address through enterprise digitalization—reducing time to market, increasing capital expenditure (CAPEX) productivity, increasing operational efficiency and improving forecasting […]
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 conference in San Antonio, […]
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 […]
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 opportunities where PAT may be implemented, since many of these decisions need to be made early, such as […]
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 workflows. At the base, level 1 involves the instrumentation and final control elements that drive the process. Level […]
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