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European Pharmaceutical Contractor

epc
Winter 2018

   
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Central Labs
Good Laboratory Practices

Ticking Boxes

Having a comprehensive checklist of Good Laboratory Practices within immuno-oncology trials can simplify study processes, as Elizabeth Koury and Jeff Mayhew at LabConnect suggest.
 
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Biomarkers and Assay Development

Marking Safety

New biomarkers are being evaluated as a promising solution to the threat of sepsis, as Professor Christene Leiper at Onorach explores.
 
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Central Laboratory Competencies

Smooth Sailing

Dr Sarah Waelde and Dr Holger Schoeneborn at SYNLAB pharma institute discuss the importance of maintaining Good Clinical Practice throughout the clinical trial process.
 
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Outsourcing
Equipment Rental Considerations
Healthy Hiring

Robin Salter at KWIPPED and Valere Horath at Quipment explain what considerations need to be made when renting equipment for a clinical trial.

 
 
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Published quarterly in
February, May,
August and November

News and Press Releases

NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA Europe in Basel

Today NDA Group announced their findings from its fifth annual comparison of drug approvals in Europe and the United States, in preparation for this year’s DIA Europe in Basel, Switzerland. The figures highlight the continued differences between the two regions, and the need for a global approach to drug development to ensure success across both continents.
More info >>

White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
More info >>

Industry Events

Cell Line Development and Engineering

23-25 April 2018, RAI, Amsterdam

Cell Line Development & Engineering 2018 event will be held 23-25 April 2018 in the RAI Amsterdam – joining the largest Bioprocessing event in Europe – BPI Europe.
More info >>

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