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Volume 5 Issue 3

Advancing Toward Proactive Quality Management

More organisations have adopted modern quality systems to move beyond manual and paper-based processes. However, a recent survey found that nearly half of companies t...
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Volume 5 Issue 3

The Evolving Landscape of Academic Research Integrity

According to Retraction Watch, over 250 papers regarding COVID-19 published since the start of the pandemic have since been retracted. While retractions are an acknow...
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Volume 5 Issue 3

Why Regulatory Convergence is Key to Global Development of Cell and Gene Therapies

There is growing excitement about the potential shown by cell and gene therapies, particularly in rare diseases. First, though, these therapies face challenges both i...
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Volume 5 Issue 3

Pro-Electrophiles A Previously Overlooked Class of Protein-reactive Extractables?

Extractable and leachable studies on primary packaging systems are well-established in the pharmaceutical industry. For extraction studies, guidelines and best practi...
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Volume 5 Issue 3

ADCs – From Lab to Clinical Development

Antibody-drug conjugates (ADCs) are a family of targeted therapeutic agents for the treatment of cancer. Compared to traditional small-molecule approaches, ADCs offer...
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Volume 5 Issue 3

New Models of Innovation in Laboratory Operations

The pandemic laid bare inefficiencies and vulnerabilities across laboratory operations where global supply chain issues, alongside high testing volumes, and the deman...
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Volume 5 Issue 3

Automated Sterile Manufacturing and Packaging Solutions Aiding Speed to Patient

The biologic market has grown expediently over the past few years, driven not only by the pandemic but also by the increasing demand for innovative therapies, the con...
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Volume 5 Issue 3

How to Keep Breathing – The Future of Inhaled Medication Testing

The delivery of therapeutics by inhalation is a medical process dating back thousands of years. The first written evidence of this can be found ca. 1550 BC in Egypt, ...
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Volume 5 Issue 3

Importance of Lyobeads and Using the MicroPress to Determine Quality Metrics

The development of lyophilised products helps reduce the impact of cold chain management from refrigerated warehouses to point use. These products, typically, benefit...
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