Achieving Agility: Real Breakthroughs Belong to the Bold

Jul 27, 2017

As the old adage goes, if you keep doing the same things it can’t come as a surprise when the outcome doesn’t improve. Organising data differently offers a way to change that, says Amplexor’s Siniša Belina in this editorial. It seems counterintuitive that life sciences companies should strive for operational agility and competitive inventiveness when there are so many regulatory obligations to get past. Red tape is traditionally the enemy of nimbleness, an imposing barrier to innovation; to breaking the mould and doing things differently.   ...

Read More

DSC: A Sensitive Tool for Comparing the Stability of Biosimilars

Jul 27, 2017

Growth forecasts for the global biopharmaceuticals market vary, but headline figures of close to USD 300 billion by the year 2021, rising from an estimated value of around USD 192 billion in 2016, are typical. Furthermore, as patents on large molecule therapeutics expire, and in a regulatory environment that encourages the development of ‘generic’ versions, the market share attributable to biosimilars is expected to increase rapidly. Recent FDA Guidance to Industry sets out an abbreviated licensure pathway for biosimilars, focusing on therapeutic protein products. Dr Lisa Newey-Keane, Life Science Sector Marketing Manager at Malvern Instruments, looks into the stability of ...

Read More

Off the Record: The Truth about Data Integrity in Pharma

Apr 11, 2017

The Food and Drug Administration (FDA) has long emphasised the importance of reliable data in pharmaceutical manufacturing. Despite this clear recommendation, recent FDA reports have highlighted an increase in data integrity violations during several recent cGMP inspections. Lee Sullivan, Regional Manager at HMI/SCADA and software expert COPA-DATA UK, explores three data integrity pitfalls to which pharmaceutical manufacturers are most vulnerable. ...

Read More

Innovation to Resolve Challenging Microsphere Drug Delivery Systems Formulation Process

Apr 10, 2017

Due to their ground-breaking benefits and market share opportunity, the production of polymeric microsphere drug delivery systems is experiencing a fast-growing demand worldwide but remains a very challenging formulation process. New drug delivery devices such as PLA, PLGA, PLG or PEG polymeric microspheres have revolutionary applications. Camille Flores-Kilfoyle, Business Development Manager at Powder Systems Limited, submits a white paper on the drug delivery systems formulation process. ...

Read More

MALDI Mass Spectrometry in Drug Discovery

Apr 10, 2017

New MALDI technology looks set to boost discovery and early development of drug candidates, delivering new information and improved performance to scientists in both target selection and drug tissue distribution imaging. In this article, Dr Rohan Thakur, Dr Meike Hamester, Dr Dale Shannon Cornett and Dr Jens Fuchser at Bruker Daltonics guide us through the mentioned topic. ...

Read More