June 15, 2015
In this article we look at the steps involved in moving from a drug substance to a successful oral solid dosage (OSD) form, and at the analytical technologies that can be helpful. In particular, we focus on gathering the required information to progress pharmaceutical development within the context of the regulatory requirements and the application of QbD.
1 min read
June 3, 2015
A promising new process – dropwise additive manufacturing of pharmaceutical products (DAMPP) – brings medicine production down to size.
1 min read
June 3, 2015
Targeted, low-dose therapies are changing patients’ lives, but these potent compounds pose significant challenges for manufacturers. We bring together three experts – John Farris, Greg Baker and John Roosa – to discuss how we can protect medicine makers in a world of increasingly powerful drugs.
1 min read
June 3, 2015
The rise of biosimilars is great news for overburdened healthcare systems, but it’s a very different proposition to a simple generic. Here, I discuss some of the many challenges – legal, regulatory, non-clinical and clinical – that manufacturers face when developing biosimilar products for global markets.
1 min read
June 2, 2015
Alternative delivery routes for large-molecule drugs are sorely needed – could a new consortium lead the way?
1 min read
June 2, 2015
Sitting Down With… David Pyott, Former Chairman of the Board and Chief Executive Officer of Allergan, Inc.
1 min read
June 2, 2015
When it comes to anti-counterfeiting, you need to go beyond legislation, think ahead, and harness the competitive edge that serialization can offer.
1 min read
June 2, 2015
The technology has barely changed over the last 30 years – surely, it’s time for some long overdue innovation.
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June 2, 2015
In the midst of wrangles over biosimilars naming and interchangeability, let’s not forget the key benefit – putting the brakes on the growth in biologics expenditure.
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June 2, 2015
Click chemistry creates biocompatible hydrogels for drug delivery and tissue engineering
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June 2, 2015
Some drug shortage prevention plans fail, while others succeed. Why? ISPE helps companies find the answer
1 min read
June 2, 2015
Scientists find a way to ‘fingerprint’ the structure of a monoclonal antibody
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June 2, 2015
A US government study reports progress – but also highlights shortfalls
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June 2, 2015
Regulators and manufacturers are readying for the opening of the US market, but legal wrangles continue to block the way
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June 2, 2015
Tell us about the 2015 breakthrough products that are shaping the way you work
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May 28, 2015
In this short series of articles, Dr Paul Kippax is looking at how recent innovations are substantially enhancing the value and informational productivity of some of our established and trusted analytical techniques. This time, the addition of Raman spectroscopy to automated imaging…
1 min read
May 28, 2015
In this second article of a short series Dr Paul Kippax is looking at how recent innovations are substantially enhancing the value and informational productivity of some of our established and trusted analytical techniques. This time, the addition of multiple detectors to a GPC/SEC analysis…
1 min read
