Sizing up the Benefits of Sterile Drug Manufacturing Techniques

Oct 10, 2017

Sterile manufacturing environments are open to many sources of potential contamination if not managed correctly. The need to ensure the safe and sterile transfer of active pharmaceutical ingredients and formulation ingredients during aseptic processing has driven the development of multiple techniques that can be employed in cleanroom environments to minimise the risks from contaminants. Christian Dunne, Global Product Manager at ChargePoint Technology, explores approaches to sterile processing and compares several techniques. ...

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So, You Think You Have an Invention?

Oct 10, 2017

The success of an invention can depend not just on the advantages that the invention provides, but also on the strength of the patent that protects it. Since a patent allows a proprietor to stop other people’s activities for a long period of time, these rights are granted judiciously to ensure that both sides of the agreement are upheld and that inventors do not obtain protection for more than they are due. Dr Emma Longland, Senior Patent Attorney and Dr Ben Tolley, European Patent Attorney at HGF, discuss in seven points all the information needed to get strong protection. ...

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DSCSA Enforcement Delay – What Now?

Oct 10, 2017

With the recent FDA announcement regarding a one-year delay in enforcement of the Compliance Policy for ‘Product Identified Requirements Under the Drug Supply Chain Security Act’ (DSCSA), many are left asking what this actually means for the wider pharmaceutical industry or for their own company’s initiatives. While the FDA communication specifically indicates a delay in enforcement, it is clear there is no delay of the law itself; a telling signal to the industry that this serialisation challenge is real, affirms Justin Schroeder, Senior Executive Director, Global Marketing & Design at PCI Pharma Services. ...

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Tungsten in the Production of Prefillable Syringes – Also Possible Without Tungsten

Oct 10, 2017

Drugs based on technologically manufactured active ingredients filled into syringes currently have a share of approximately 15% of the total market value for pre-filled syringes. These high-growth biotech drugs are sensitive with regard to possible interactions with individual syringe components. Syringe system manufacturers therefore strive for a reduction or avoidance of syringe components like silicone oil or tungsten pin. This article by Bernd Zeiss, Manager Technical Support Medical Systems at Gerresheimer Bünde GmbH, tackles the issue of reduction and avoidance of tungsten in prefillable glass syringes. ...

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