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Volume 14 Issue 2

PDA Europe Annex 1 Workshop

The Pharmaceutical world and those involved with the manufacture of sterile products are anxiously looking out for the publication of the final approved revision of ...
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Volume 14 Issue 2

Annex 1-Implementation of the Final Draft

Annex 1 “Manufacture of Sterile Medicinal Products” was first published in 1971 and forms part of EudraLex Volume 4 [1], which interprets the basic principles of GMP...
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Volume 14 Issue 2

Latest Developments in IP Strategies for Pharmaceuticals

The strategies used to create and maintain strong-pharmaceutical patent portfolios must evolve with developments in the pharmaceutical space. These developments incl...
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Volume 14 Issue 2

Pharma’s Time to Jointly Redefine Healthcare is Now

The challenge of ensuring healthcare sustainability, the rise in more targeted treatments, and a shift in emphasis to preventative interventions, not to mention the ...
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Volume 14 Issue 2

The New Age in Strategic Outsourcing Lies in the Mature Portfolio

Companies must safeguard their mature portfolios while continuously innovating and developing new products. But in-house resources are stretched and often lack the b...
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Volume 14 Issue 2

Pathway for Marketing Authorisation Approval of Medical Device in US

The process of developing a revolutionary medical device from the proof-of-concept stage to the marketing stage is expensive and complicated. The creation of a new p...
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Volume 14 Issue 2

Applying Advanced Powder Testing to Tackle the Toughest Formulation Challenges

The application of high throughput screening techniques and computational chemistry has resulted in a marked shift in drug candidates with identified therapeutic pot...
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Volume 14 Issue 2

Option 1 – Pressure’s On: How Roller Compaction is Helping Pharma’s Formulators Achieve Better Poorly Soluble API Delivery

Advances in combinatorial chemistry and high-throughput screening continue to introduce poorly water-soluble active ingredient (API) chemistries into pharmaceutical ...
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Volume 14 Issue 2

Crystallisation Development – A Quality by Design Approach using Modelling

Nearly all synthetic steps in industrial chemical manufacturing end with crystallisation. This is because it is almost always the most efficient method to purify and...
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Volume 14 Issue 2

Achieving Faster Investigational New Drug Timelines with a Robust Cell Line Development Strategy

Technological advances in drug manufacturing equipment and process optimisation play a significant role in increasing the speed of the clinic of critical biologic dr...
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