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Volume 14 Issue 1

Evolving Clinical Trial Landscape Requires Quality Focus

Striving to deliver the very best outcomes sits at the heart of clinical research. Arguably the mechanism for delivering that “perfect” outcome rests squarely on …

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Volume 14 Issue 1

Real-world Data can Bridge the Gap Between Traditional Trials and a Patient-centric Future

Patient safety has been the primary focus of clinical trial design since 1947 when the Nuremberg Code outlined the ethical guidelines for clinical research. Consisting …

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Volume 14 Issue 1

Improved Antibody Purification Process Through Use of Additives

Downstream biopharmaceutical processing utilises a series of interlocking and sequential operations, including filtration and process chromatography steps, that incrementally increases the purity of the target …

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Volume 14 Issue 1

The Role of the Clean Room in LAL Production

The standard endotoxin test utilises a reagent called Limulus Amoebocyte Lysate (LAL). This test is the most widespread test of bacterial endotoxin in parenteral injections …

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Volume 14 Issue 1

Putting your ATMP Process on the Map

Strategies for Scaling Out Facilities to Meet Commercial Development Realities Cell, gene, and tissue therapies are transforming medicine, showing meaningful efficacy in treating – or …

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Volume 14 Issue 1

Emerging Challenges for Data Integrity in the Pharmaceutical Sector

Processing power has completely reshaped manufacturing over the last 20 years, especially in pharmaceutical production. Businesses can now monitor, analyse and model far more data …

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Volume 14 Issue 1

Automation in Pharma Packaging – When and When not to Invest?

The pharmaceutical and biotech industry has expressed clear imperatives when it comes to automation. According to Pharmaceutical Manufacturing’s Smart Pharma survey, in 2021 88% of …

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Volume 14 Issue 1

One Thing After Another – The Pathway Towards Successful Serialisation

Pharmaceuticals will always be attractive to counterfeiters. They are relatively inexpensive to produce and easy to make look convincing. The regulation and enforcement infrastructure to …

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Volume 14 Issue 1

A Robust Product Delivers a Reliable Solution to the Pharmaceutical Cold Chain

At its simplest, logistics is the art of getting a product from A to B. When it comes to the pharmaceutical cold chain, however, nothing …

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Volume 14 Issue 1

Purchase or Rental Temperature-controlled Packaging for Pharma Logistics – One Size Doesn’t Fit All

Cold chain packaging and logistics perform an integral part in the safe shipment of pharmaceutical payloads worldwide. Ensuring the efficacy of high value, life-giving pharmaceutical …

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