We conclude our series on improving cell therapy manufacturing with a closer look at the review by exception process. In the manufacturing process of cell therapeutics, product cycle times are extremely short and any exceptions occurring during the production process...
Manufacturing processes have long been paper-based with log entries, initialing, signoffs and other transactions to manually record. While automation systems have captured some of this manual recordkeeping, they have not been able to capture everything. In batch...
In an earlier post, Managing the Chain of Identity in Cell Therapeutics Manufacturing, we highlighted how the manufacturing process of these cell therapies must be performed with absolute accuracy the first time since each batch is produced for a specific patient....
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...
The pharmaceutical and biotechnology manufacturing industries are challenged with errors in manual entries in the production process, getting batches right the first time, reaching final signoff for batch release, and managing the data accumulated throughout the...
Author: Jonathan Lustri I have previously written about a design strategy where the process control system (PCS) is the primary system driving all procedural batch activity within a pharmaceutical process. In this architecture, the PCS ISA-88 procedural model must...
For those not in the pharmaceutical and biotech manufacturing industries, if you ever visit one of these facilities you'll be struck by the clean, shiny stainless steel vessels and piping. Given the importance of hygiene in the production of medicines, most processes...
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 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...
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...
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 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,...
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