Process Analytical Technology (PAT) for Biotech: A Review of Recently Reported Applications in Fermentation and BioProcessing
Fermentation and bioprocessing play critical roles in the discovery and manufacture of new pharmaceuticals and specialty chemicals, and in the sustainable production of bulk fuels and commodity chemicals. Yet fermentation processes are often operated with a minimal level of monitoring and control, limiting the ability to optimize yields and production rates. 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 →
During the fall, a number of events related to green chemistry, green engineering, and other sustainability topics for the pharmaceutical and chemical industries are planned. Some notable green events are:
This is a guest blog post by Paul Thomas. Paul is Senior Editor of Pharmaceutical Manufacturing magazine, PharmaManufacturing.com, and PharmaQbD.com. He can be reached firstname.lastname@example.org, and followed on Twitter@PaulThomasPharm.
There has been a lot of discussion within pharmaceutical circles of late as to what’s ailing the Quality by Design (QbD) movement. There are those who say that nothing is. There have been some “striking success stories on how Quality by Design can reduce defects and variability,” noted FDA CDER’s Janet Woodcock at the DIA annual meeting in June. QbD is “a success story that is evolving,” she added. Continue reading →
METTLER TOLEDO FBRM and Opt Diss Fiber Optic UV for Dissolution Testing in Distek Evolution 6100
USP tablet dissolution testing is recognized as the standard analytical method used in the pharmaceutical industry.
Traditionally, dissolution has been performed in the analytical laboratory and tests were conducted with the final product. But in recent years dissolution testing has become a development tool for Quality by Design (QbD), and testing has expanded to include dissolution and disintegration tests which screen product performance during drug product development. Continue reading →
Over the last five years, FDA and ICH quality initiatives created a paradigm shift in pharmaceutical discovery, development, and manufacturing. At the 17th International Process Development Conference, Christine Moore gave a presentation on the FDA perspective on Quality by Design (QbD) in pharmaceutical development. During her presentation, Christine discussed the advantages that the U.S. Food and Drug Administration (FDA) believes Quality by Design offers, including: Continue reading →