While reviewing the technical program for the upcoming 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting, I noticed several papers of interest to those of us who work in crystallization: Continue reading
Last week, I had the opportunity to attend the BioProcess International Conference in Providence, RI. Many of the sessions I attended highlighted the advancement of the Bio-Pharmaceutical industry in applying the principles of Quality by Design (QbD). Continue reading
At last week’s BIO International Conference in Chicago, I had the chance to sit down to lunch with former Presidents Bill Clinton and George W. Bush. It was a fairly intimate gathering with about 2,000 colleagues (just guessing). Quite honestly, I was in the nose-bleed section, but it was still a memorable opportunity. Click to read the offical news release.
This is not a political blog, so what did two past presidents who had led the USA for most of the past two decades have to do with biotechnology?
Q: What are the most important factors in selecting the right process analytical technologies for process optimization and scale-up from lab R&D to manufacturing?
The following is a simplified overview of what is important.
My thoughts on the 3 R’s:
A starting point for any effective attempt to optimize and control a process is the identification and reliable measurement of critical process parameters that directly influence product quality and process efficiency. Whether the measurements are on-line or off-line, direct or inferred – there must be a connection between what is measured and what is desired in the final product. With processes being pushed for further efficiency and productivity, reliable real-time measurements become even more critical for enabling real-time decision making and automated control.
Selecting an on-line measurement to be used as the basis of scale-up requires consideration of a number of issues related to measurement and instrument precision and sensitivity. These can be described in terms of robustness, repeatability and reproducibility.
In an ideal world, you may want to directly measure the crystal population within the crystallizer (a critical product quality attribute) and measure the supersaturation which is driving the process (a critical process parameter). Today’s advanced Process Analytical Technology (PAT) allows you to measure both of these critical parameters in real time. But where should you begin – especially if budget constraints limit you to implementing only one advanced measurement. Continue reading
As a follow-up on last week’s post regarding the implications of a well-designed crystallization process, including how Tim Bell of DuPont Engineering wrote: “Crystallization is notoriously difficult to scale-up…”, we will now address why crystallization is such a complex process. Continue reading
Crystallization is a critical process for the purification and isolation of chemical compounds in the manufacture of many fine chemical and pharmaceutical products. The results of the crystallization step have far reaching impacts on overall process efficiency and final product quality. Crystallization is also a very difficult process to effectively optimize and control. Crystallization is inherently complicated simply by being a process involving the creation and formation of solid particles.
Timothy A. Bell, of DuPont Engineering Research and Technology, wrote a review of the challenges of scaling-up particulate processes where he stated: Continue reading
A couple of weeks ago, I posted an article about my colleagues’ attendance at POWTECH in Nuremberg. I was recently informed that while in Nuremberg, they accepted an award for this year’s most outstanding innovation in the field of Particle Characterization and Material Science at POWTECH. I thought I would share some of the details with you:
This extended abstract summarizes collaborative research between GEA (Niro) Pharma Systems and METTLER TOLEDO in the application of process analytical technologies (PAT) to the monitoring, optimization and control of Precision Fluid Bed Granulation and Fluid Bed Coating.
Download the extended abstract from the presentation given at the 7th World Meeting on Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology.
Andrew Birkmire, Dr. Kim Walters, GEA (Niro) Pharma
Dr. Mario Hubert, BMS
Eric Dycus, Terry Redman, Ben Smith, METTLER TOLEDO
METTLER TOLEDO is pleased to announce that Dr. Martin D. Johnson of Eli Lilly won the award for Best Paper at the 17th International Process Development Conference (IPDC).