The life science industry faces the challenges of developing and delivering life-changing medicines at an accelerated pace, all while maintaining quality and safety ...

AI use cases are rippling across commercial biopharma, helping companies make faster, more informed decisions. Yet almost 70% of top generative AI (GenAI) users cite...

When anything changes to a product’s make-up or manufacture, a whole chain of events is triggered, starting with an assessment of the regulatory impact in each regul...

When investigational medicinal products (IMPs) are exposed to conditions outside of their approved storage range, sponsors need to be ready to act or risk the integr...

Quality Assurance Evolution in the Biopharmaceutical CDMO Industry – stricter regulations, technological advancements, risk management, globalisation and client expe...

Pharma companies remain at differing levels of readiness for implementing ISO IDMP product data standards, and in their maturity around adopting FAIR data principles...

Viral vector-based therapeutics have revolutionised modern medicine, enabling precise gene delivery for treating genetic disorders, cancers, and infectious diseases....

The emergence of RNA vaccines against SARS-CoV-2 has revolutionised the biomedical field, offering unprecedented flexibility, precision, and scalability in therapeut...

“What we believe in, is putting the best biology we can into our models to mimic human biology”. In recent years, there have been significant advances in technolo...

When determining a test for pyrogens and bacterial endotoxin, there are many regulations, needs, limitations, and techniques to consider. The original pyrogen test, ...