Ensuring a Carefully Designed and Executed Product Packaging Interaction Study for Concise Cost-Effective Evidence in Support of New Drug Product Development

Apr 11, 2017

The US Food and Drug Administration (FDA) Guidance for Industry document ‘Container Closure Systems for Packaging Human Drugs and Biologics’, addresses the review and evaluation of packaging requirements. According to this document, each new drug application (NDA) or abbreviated new drug application (ANDA) should contain sufficient information to demonstrate that a proposed container closure system and its components are suitable for its intended use. Last, but not least, Mike Ludlow, Technical Study Manager, CMC Analytical Services at LGC, focuses on product packaging and new drug development. ...

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The Advent of Patient-centricity: What Does it Actually Mean?

Apr 11, 2017

There is a lot of buzz in the pharmaceutical and healthcare industry right now around the concept of ‘patientcentricity’. The term can mean many different things to a lot of different factions within the healthcare space. With high-profile headlines about drug pricing in the market, the industry is coming around to the enlightening thought that it ought to be more overtly focused on the patient. Justin Schroeder, Executive Director, Marketing, Business Development & Design at PCI Pharma Services explains this is now borne out in many facets of the business. ...

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Innovative Glass Production for Pharmaceutical Packaging

Apr 11, 2017

Why is glass still the first choice of primary packaging for most pharmaceuticals today and how much high-tech do you need to manufacture a glass container that has good filling properties and keeps the content safe? IPI Media Director, Anthony Stewart, visits Gerresheimer`s pharmaceutical glass facilities in Lohr and Wertheim, and learns the process of the company’s high-quality glass manufacturing. ...

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Simplified Bioprocess Setup through Automated Process Control

Apr 11, 2017

Learning to use a bioprocess controller is a complex and often intimidating endeavor for the beginner. Indeed, even with previous bioprocess experience, moving to a new software platform can entail much learning and reduce efficiency. Although many textbooks and manuals exist on the subject, they are no substitute for hands-on experience. Ulrike Becken and her team at Eppendorf AG Bioprocess Center explain how automated process control can help users who are less familiar with bioreactors and fermenters. ...

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Antimicrobial Copper vs Antimicrobial Resistance

Apr 11, 2017

The antimicrobial properties of copper have become widely known, harnessed by hospitals around the world in the form of touch surfaces that continuously reduce bioburden. Now, a potential role in combatting antimicrobial resistance is being proposed by researchers. In his article, Bryony Samuel at Copper Development Association describes some of the latest developments in antimicrobial copper, looking at new science, its growing inclusion in guidelines and ratings systems, and a high-profile installation at a leading London research facility. ...

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