Quality by Design: How to Harvest the Benefits?

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Phamaceutical Industrie is Changing

The European regulations consider the QbD approach an “alternative” or even “enhanced” approach that companies are allowed to use, but it is very often stated that there has been few submissions and there are still only few applications of its use. Which is true. At least so far. However, the pharmaceutical industry is changing.

After the blockbuster era the main driver of the pharmaceutical industry is speciality drugs. Much smaller indications than the traditional pharma blockbusters, but nevertheless some significant business areas. Who predicted five years ago that the biggest pharma products in the world would be for arthritis or hepatitis C?

Back when cardiovascular, ulcer and metabolic were some of the biggest drug market drivers it was really hard to predict that fairly small indications treated with speciality medicines would drive the future growth of the pharmaceutical industry. But this is part of the new pharma reality.

Some pharmaceutical companies have turned this into a business opportunity. They are developing their new products on a platform of existing products, product knowledge and process knowledge.

They have implemented methods and systems for knowledge management which enable them to speed up applications and to implement robust and agile manufacturing systems. Some of them are even based on next generation technology of closed systems, containment and continuous manufacturing.

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