For pharmaceutical and biopharmaceutical manufacturers, scaling up production has typically meant large, 5000+ liter stainless steel bioreactors for the process. These require cleaning and sterilization between batches. Market demands are driving the need for more...
pharmaceutical manufacturing
Taming Big Data in the Life Sciences
The Interphex conference for pharmaceutical and biotech manufacturers is underway this week in New York City. Emerson's Bob Lenich is presenting Big Data in Life Sciences Manufacturing. Bob opens citing one pharmaceutical manufacturer who generates 5000 data points...
Manufacturing Execution Systems in Drug Research and Development
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 I caught up with Emerson's Zuwei Jin whom you may recall from...
Outlook and Trends for Biotech Industry
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...
Best Practice for MES-SAP interface Factory Acceptance Testing
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...
Advancing Innovation in Pharmaceutical and Biologics Manufacturing
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...
IIoT in the Life Sciences Industry
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...
Tech Transfer in Drug Development Pipeline and Industry 4.0
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...
Technology Trends for Life Sciences Manufacturers
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...
Data Integrity for Pharmaceutical and Biotech Manufacturers
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...
Increasing Autoclave Reliability via Machine Learning Technology
ARC Advisory Group's Paula Hollywood moderated a session, IT/OT/ET Convergence at the 2018 ARC Industry Forum. Here's the description from this session: The convergence of IT (Information Technology at the enterprise level) and OT (Operations Technology, the...
Managing the Chain of Identity in Cell Therapeutics Manufacturing
Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as: …the transplantation of human or animal cells to replace or repair damaged tissue. From a manufacturing...
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