Tag Archives: quality by design

Use of Process Analytical Technology (PAT) for Biotech

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

Quality by Design (QbD) at the BioProcess International Conference

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

Going Green: Fall Events for the Pharmaceutical and Chemical Industries

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:

Process Analytical Technology (PAT) & Laboratory Automation Developments in the Pharmaceutical & Chemical Industries

Dominique Hebrault will present the online seminar New Developments in the Use of PAT and Laboratory Automation from the Pharmaceutical and Chemical Industries on September 15.  Specific case studies that Dominique will discuss include: Continue reading

Is Quality by Design (QbD) Stuck, Struggling, or Just Slow to Mature?

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 at pthomas@putman.net, 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.
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Predictor of Dissolution Performance in Fluid Bed Granulation

In July, I announced that I would be chairing next week’s In Process Particle Forum  being held in Iselin, NJ.  Today, I want to highlight one of the papers that will be presented at In Process Particle ForumSteve Mehrman of Johnson & Johnson will present on using FBRM C35 during fluid bed granulation development and scale-up.

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AIChE 2010 – Quality by Design (QbD) Session

One presentation that will be given at the Quality by Design Session at the 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting will be: Optimizing and Controlling High Value Processes Using the Principles of Quality by Design (QbD) Advanced Tools Such as Real-Time In Situ Particle Characterization, In Situ Mid-Infrared Spectrometry and Reaction Calorimetry.
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Understanding Dissolution Inconsistency Through In Situ Particle Characterization and Root Cause Analysis

Dissolution-Disintegration-Distek-METTLER-TOLEDO-FBRM

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.
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FDA Perspective on Quality by Design (QbD) in Pharmaceutical Development

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

From AAPS 2009: How To Improve Roller Compaction Processes

At the 2009 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting in Los Angeles, Gerald Burke presented a case study on how Patheon Pharmaceuticals improved roller compaction processes.  Specifically, the case study focused on the influence of roller compactor settings on Critical Quality Attributes (CQAs) and the early prediction and control of granule porosity. Continue reading