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No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion Welcome ICH Q11 Framing a QbD Design Space with Tolerance Intervals Can QbD Get Its Definitions Straight?
 
No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion

No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion

There's been a shift in the industry in the past 18 months, says Emerson's life sciences expert, from experimentation to broad implementation.

Design of Experiments Helps Boost Key Intermediate Yield by 18%

How recent design of experiments work at Codexis Labs in Singapore led to an 18% increase in yield of a key intermediate.

Welcome ICH Q11

Welcome ICH Q11

The final document, pertaining to the development and manufacture of drug substance, is now available and moves Q11 into its implementation phase.

Framing a QbD Design Space with Tolerance Intervals

Framing a QbD Design Space with Tolerance Intervals

Via the response surface method, more conservative tolerance intervals can be imposed, and a more robust design space achieved. Mark Anderson of Stat-Ease demonstrates how.

Can QbD Get Its Definitions Straight?

Can QbD Get Its Definitions Straight?

After all these years, wonders Emil Ciurczak, why is there still so little agreement on basic terminology?

Winning the Space Race

Winning the Space Race

11 April 2010

ICH Q8 and the QbD guidance issued by the FDA offer pharmaceutical manufacturers a significant opportunity to design quality into their manufacturing processes instead of inspecting it in after the fact.

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BioProcess Control: What the Next 15 Years Will Bring

09 April 2010

Mammalian cell culture bioreactor processes are difficult to characterize and they demonstrate variability between batches. Without sufficient online detection and control, variations can lead to a high number of failed batches.

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A QbD-based Methodology for the Rapid Development of LC Methods

09 April 2010

Using ICH Q8 principles for Design of Experiments, S-Matrix Corp. has developed a means of defining a design space for optimizing the performance and robustness of liquid chromatography operations.

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Thoughts on Applying QbD to Analytical Methods

09 April 2010

QbD has been applied to manufacturing processes but can it be applied to analytical methods?

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Does Six Sigma = QbD in Production?

09 April 2010

The debate over whether the Six Sigma process improvement methodology is applicable to the pharmaceutical sector, and in what way, has been on the table for some time. It seems clear that "copying" the automotive model, for example, is not appropriate, because pharmaceutical processes have little to do with assembly lines.

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Webcast: Redefining Pharmaceutical Process Validation

09 April 2010

FDA's new process validation guidance spells out the new rules for process validation.

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