All articles by Miranda Mclaren

Building Annex 1 readiness into primary packaging

The revised EU GMP Annex 1 guideline places contamination prevention within a coordinated, risk-based strategy. It identifies containers, closures, supplier…
Transitioning from lab bench to GMP: What research scientists should know about manual aseptic filling

Many breakthrough therapies originate in research labs: academic institutions, biotech startups, and translational centers. The research-grade environments in which these…
Pharma’s supplier sprawl problem: When more vendors create less control

Many pharmaceutical companies have steadily accumulated logistics partners as each product launch, market entry or acquisition added another provider into…
Oral solid dose at a turning point: Scaling for the next generation of therapies

As the first oral GLP-1 receptor agonists launch in 2026, we are reminded yet again of the enduring importance of…
The rare disease revolution: The state of play for CGTs in orphan diseases

Rare diseases are chronic conditions that affect between 3.5% and 5.9% of the global population. About 80% of rare diseases…

Commercialising drugs in Europe: Lean models for first-time launchers

In 2025, 193 innovative drugs received approval in Europe, including 133 new molecular entities (NMEs). Over half – 56% -…
Lyophilisation is growing in pharma, but technical challenges persist

Lyophilisation, or freeze drying, is the process in which a liquid drug is converted into a stable powder via sublimation,…
China-ready by design: Leveraging NMPA’s new 30‑working day IND pathway

Over the last decade, China has become a key destination for oncology clinical trials, with Chinese sites increasingly incorporated within…
Why manual aseptic filling often provides faster start dates than automated lines

A Phase 1 start date may be tied to investor milestones. A rare disease therapy may represent a small patient…
Biomarkers in Nephrology Research: From Exploratory to Decision-Making Tools

While strategic use of biomarkers in clinical trials has traditionally been associated with oncology, the potential for growth across other…

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