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Manufacturing

The SSPC: leading the way for next-generation medicines manufacture

3 September 2015 | By Benjamin K. Hodnett, Anita R. Maguire, Pat J. Guiry, Ake C. Rasmuson, Brian Glennon and Abina M. Crean - SSPC

The Synthesis and Solid State Pharmaceutical Centre (SSPC), a global hub of pharmaceutical process innovation and advanced manufacturing, is funded by Science Foundation Ireland (SFI) and Industry, and represents a unique collaboration between 22 industry partners, nine research performing organisations and 12 international academic collaborators. It is a €42 million…

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Rapid methods update: revisions to a United States Pharmacopeia chapter

3 September 2015 | By Michael J. Miller, PhD Microbiology Consultants, LLC

From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation.

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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

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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NICE tackles overuse of antibiotics

18 August 2015 | By Victoria White

NICE, the UK health watchdog, has published guidance to help doctors, nurses and pharmacists promote and monitor the sensible use of antibiotics...

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Wickham Laboratories announces upcoming webinar on Rapid Methods

7 August 2015 | By Wickham Laboratories Limited

Join us for a discussion on Rapid Screening Techniques, October 1 3PM London/10AM New York...

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Antibiotic resistance poorly communicated and widely misunderstood

31 July 2015 | By Victoria White

People in the UK have little awareness of what ‘antibiotic resistance’ means, according to new research commissioned by the Wellcome Trust...

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Cherwell launches refreshed website for Cleanroom Microbiology Solutions

30 July 2015 | By Cherwell Laboratories

Cherwell Laboratories, specialists in cleanroom microbiology solutions for the pharmaceutical and related industries, have announced the launch of a refreshed website....

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CPhI Korea opens as South Korea emerges as global leader in biosimilar trials

27 July 2015 | By Victoria White

CPhI Korea, organised by UBM EMEA, will return to the COEX in Seoul, South Korea – 7 to 9 September 2015 – following a successful inaugural event last year...

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Phase I clinical trial of oral formulation of MGB-BP-3 for treatment of Clostridium Difficile infections begins

21 July 2015 | By Victoria White

The first group of healthy volunteers have been dosed in a Phase I clinical trial assessing the safety and tolerability of an oral formulation of MGB-BP-3...

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FDA QIDP designation for Motif’s iclaprim for HABP

20 July 2015 | By Victoria White

The US FDA has designated Motif Bio's iclaprim as a Qualified Infectious Diseases Product (QIDP) for hospital acquired bacterial pneumonia (HABP)...

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Scientists find new streptococcus variant causing severe infections

15 July 2015 | By Victoria White

Scientists have discovered a new subtype of emm89 streptococcus that has contributed to a rise in disease cases in the UK over the last 17 years...

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Issue #3 2015 – Digital edition

3 July 2015 | By European Pharmaceutical Review

In Issue #3 2015: Regulatory Insight, Microfluidics, PCR in-depth focus, Drug Delivery, Content Uniformity, HPLC, Microbiology in-depth focus, NMR, PAT and much more...

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Microbiology In-Depth Focus 2015

3 July 2015 | By European Pharmaceutical Review

In this Microbiology In-Depth Focus: Diversity of bacteria in pharmaceutical water: significance and impact on quality, Risk-based environmental control and monitoring and Microbiology Roundtable...

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Drugs shortages are finally being addressed

3 July 2015 | By David Elder (JPAG member and consultant)

Maintaining the security of the supply chain for drug products is a significant responsibility to ensure the sustained availability of safe medicines...

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