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23.06.2016

Article

Quality by Design: How to Harvest the Benefits?

Quality by Design is decried as a theoretical, academic and complex system. In the meantime, it is set as a standard in the US pharmaceutical industry. In Europe, the concept is slowly accepted. Fact is: Development based on QbD will be safer, faster and more agile.

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06.05.2016

Article

Quality Metrics in Pharmaceuticals – Chance or Challenge? – Get the Expert's Perspective!

Quality Metrics in pharmaceutical manufacturing: challenge or opportunity? A new way of measuring quality performance and quality culture in pharmaceutical companies is on the horizon. Are European companies ready for FDA´s Quality Metrics concept?

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21.03.2016

Article

Why Specialty Medicine Becomes a Challenge to Manufacturing

After the traditional blockbuster era the new blockbusters are specialty medicines — This may change the manufacturing strategy for many pharmaceutical companies and it means new opportunities and challenges for pharmaceutical manufacturing. But today’s technology and equipment r...

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25.11.2015

Article

Breakthrough of Continuous Pharmaceutical Manufacturing creates Opportunities

Over the last couple of years the term continuous manufacturing has become increasingly popular in pharmaceutical manufacturing. But it is still hard to answer the question: “Which efficiency benefits can be reached with continuous manufacturing in comparison to the batch procedu...

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25.06.2015

Article

Future-proof Solutions have Priority

The high tech and biotechnology trends are good news for European engineering companies.This is reflected among other things in the order books of the engineering company NNE Pharmaplan. However, Stefan Berg, General Manager for NNE Pharmaplan Germany and Switzerland as well as C...

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05.03.2015

Article

Is Quality by Design a Forgotten term?

Quality by Design—is a powerful instrument to make pharmaceutical production safe, robust and more efficient. But ten years after starting we are still at the beginning of the QbD era. What has to be done to make the concept a breakthrough?

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19.11.2014

Article

Why Small Scale Pharmaceuticals Require Special Solutions

Specialty Medicines and Facilities of the Future are the new challenges–The biggest pharmaceutical products are now specialty medicines. Not 'biggest' from a volume perspective, but from a value perspective. This has significant implications for manufacturing, especially on flexi...

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15.10.2014

Article

Where is Big Pharma Headed After the Patent Cliff?

The low hanging fruits have been picked - after the patent cliff pharmaceutical manufacturers have to face another challenge. Product portfolios have changed from large to small volumes. There is a need for more flexibility and the question is: Are pharmaceutical manufacturers re...

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05.08.2014

Article

The Process Validation Trend — Preparing for the Future

In January 2014 the "new" FDA process validation guide celebrated its 3 years anniversary - and in February the European Commission launched EMA's draft to a new European Annex 15 for Validation and Qualification in the GMPs. However, although Annex 15 is only a draft, we already...

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14.05.2014

Article

Personalized Medicine — What Does it Mean for the Future?

It is broadly accepted that we see a mega–trend towards smaller products and smaller batch sizes. The requirements for much increased flexibility and the span between small and big products in a facility are becoming a manufacturing challenge. And this is probably only the beginn...

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17.03.2014

Article

Fast to Market — The Coming Challenges for Pharma–Production

Pharmaceutical manufacturing operations must prepare for faster drug approvals and increased time-to-market pressure. Pharmaceutical companies, which aimed to be Best-in-Class, will need to explore new ways to make the “facilities of the future". Gerd Moelgaard about the future o...

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14.03.2014

Article

How to save Costs through Automatic Granulate Inspection

Innovative equipment design in combination with modern image processing technology allowed to reduce the manufacturing costs of a high quality medical device product. The new process solution replaces a costly visual inspection step carried out by several qualified QC staff.

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20.01.2014

Article

How Does the Facility of the Future Look Like?

Experts all around the world are working on the future of pharmaceutical production. Gert Moelgaard, Vice President Strategic Development, NNE Pharmaplan is one of them. PROCESS Worldwide asked him about the schedule for implementation.

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02.04.2013

Article

How to manage the patent cliff?

Balancing between patent cliff, generic drugs and emerging markets the pharmaceutical industry has to position itself anew. This article is carrying out an analysis.

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27.02.2009

Article

A New Conceptual Approach and the Trend to Disposables in Biopharmaceutical Manufacturing

The worldwide pharmaceutical market is very lucrative for pharmaceutical producers and also for equipment suppliers, service providers and consultants. a number of capital projects have been initiated and completed worldwide, creating what appears to be the ideal growth market fo...

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19.11.2008

Article

The Road to Success in Pharmaceutical Plant Engineering

Tight deadlines, extreme quality standards and massive cost pressure—these are the demands which currently dictate pharmaceutical plant engineering. The new but familiar market of the future is biotechnology, although chemical syntheses are also back in demand.

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