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Drug Manufacturing

 

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The application of skip testing to drug substance manufacture

29 February 2016 | By Phil Borman, Simon Bate and Keith Freebairn, GlaxoSmithKline

Skip testing is a process employed to reduce the analytical drugs testing burden and lends itself to processes with high frequency batch production. Rather than test all batches within a given interval, pre-selected batches are assessed and the other batches ‘skipped’. This reduction is justified as it is shown that…

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Dolomite aids drug encapsulation studies

12 January 2016 | By Dolomite

A Dolomite microfluidic system is helping Dr Samar Damiati, Assistant Professor in the Biochemistry Department at King Abdulaziz University in Saudi Arabia, perform drug encapsulation studies...

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Designing a novel continuous manufacturing plant with superior monitoring and control

6 January 2016 | By Ravendra Singh, Jun Zhang, Marianthi Ierapetritou and Rohit Ramachandran, The State University of New Jersey

There is a growing interest in manufacturing the pharmaceutical product continuously . Along with other advantages , it provides an appropriate platform to implement suitable monitoring and control architecture, to improve the product quality and minimise product rejection and operating expenses. Continuous pharmaceutical manufacturing can be also considered as a…

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Continuous flow processing in the pharma industry – an unstoppable trend?

22 October 2015 | By Bernhard Gutmann and Christian Oliver Kappe, University of Graz

Continuous flow processes have many distinct advantages over discontinuous batch production and therefore, in the last century, continuous operation has become by far the most dominant form of production for high-volume and low-cost materials such as petrochemical and commodity chemicals. The first applications of continuous processes in the pharmaceutical industry…

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PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing

3 September 2015 | By Cenk Undey, Tony Wang, Bryan Looze, Yingying Zheng and Myra Coufal - Amgen

Predictive monitoring is a key feature of biopharmaceutical manufacturing; making predictions about the key process end points such as process performance indicators or quality attributes using a process model offers the unique advantages of process improvement and optimisation, and helps give insights into variability.

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Sartorius Stedim Biotech and GE Healthcare sign worldwide OEM supply agreement

1 September 2015 | By

Sartorius Stedim Biotech, a leading international supplier for the biopharmaceutical industries and GE Healthcare’s Life Sciences business, a provider of start-to-finish enterprise solutions, technologies and services for biopharmaceutical manufacturing, today announced they have entered into a worldwide OEM supply agreement for Sartorius Stedim Biotech’s innovative membrane adsorber purification technology, Sartobind™.

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Precompetitive collaborations in the pharmaceutical industry

20 April 2015 | By Dave Elder, GlaxoSmithKline and JPAG

Increasing research and development costs, low productivity, reduced product life cycles, governmental pricing containment, convergence of technologies and increasing regulatory oversight are challenges that increasingly provoke pharmaceutical companies into making precompetitive collaborations with other organisations.

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Manufacturing Solutions: Continuous processing

20 April 2015 | By Ivo Backx, Manager, Business & Project Development for the Pharmaceutical Industry, Siemens

Ivo Backx of Siemens discusses continuous processing in the context of the company’s Simatic PCS 7 system and PAT software...