The Wall Street Journal ran an article in September 2003, entitled "New Prescription For Drug Makers: Update the Plants", comparing and contrasting pharma manufacturing techniques with other industries. The subtitle ran, perhaps unfairly, "After Years of Neglect, Industry Focuses On Manufacturing; FDA Acts as a Catalyst".
Our DynoChem software entered the industry a few years prior, the prototype having been developed as a dynamic simulator within Zeneca, so that users could "create a dynamic model without having to write differential equations". We first proved that the software could be used to solve process development and manufacturing problems (e.g. with hydrogenations, exothermic additions), then rewrote the source code and began to add features that made modeling by non-specialists an everyday reality.
There have been many pharma industry leaders who have recognized the potential for modeling to help modernize development and manufacturing. One example is Dr Paul McKenzie and his leadership team at Bristol-Myers Squibb (BMS) at the time, who cited the Wall Street Journal piece in an invited AIChEJ Perspectives article and also in presentations like this one at the Council for Chemical Research (CCR) in December 2005 - you can get the full slide deck here.
Today, while the landscape for data storage, sharing and visualization has moved ahead significantly, with the emergence of ELN, cloud and mobile, the chemical and engineering fundamentals of defining and executing a good manufacturing process remain the same:
Our Scale-up Suite extends these capabilities to more than 100 pharma development and manufacturing organizations worldwide, including 15 of the top 15 pharmaceutical companies. This broad and growing base of users, armed with clean and modern user interfaces, calculation power and speed in Reaction Lab and Dynochem 5, provides a firm foundation for the next wave of industry transformation.
We're always delighted to hear what users think. Here are some recent quotes you may not have seen yet:
Our DynoChem software entered the industry a few years prior, the prototype having been developed as a dynamic simulator within Zeneca, so that users could "create a dynamic model without having to write differential equations". We first proved that the software could be used to solve process development and manufacturing problems (e.g. with hydrogenations, exothermic additions), then rewrote the source code and began to add features that made modeling by non-specialists an everyday reality.
There have been many pharma industry leaders who have recognized the potential for modeling to help modernize development and manufacturing. One example is Dr Paul McKenzie and his leadership team at Bristol-Myers Squibb (BMS) at the time, who cited the Wall Street Journal piece in an invited AIChEJ Perspectives article and also in presentations like this one at the Council for Chemical Research (CCR) in December 2005 - you can get the full slide deck here.
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| Cover slide from presentation by Paul McKenzie of BMS at CCR Workshop on Process Analytical Technology (PAT), December 13, 2005, Rockville, MD |
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| Some capabilities required to develop robust and scalable processes, from the 2005 CCR presentation |
We're always delighted to hear what users think. Here are some recent quotes you may not have seen yet:
- "If you can book a flight on-line, you can use Dynochem utilities" [we like this especially because we hear that using some other tools is like learning to fly a plane]
- "Our chemists are thoroughly enjoying the capabilities of Reaction Lab software and are quite thrilled with the tool".
In the next post, we will look at the increasingly central role of mechanistic modeling in process development.
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