All articles by Staff Writer
Staff Writer
APIs to the rescue?
Oral bioavailability remains one of the biggest challenges in drug development, particularly for small-molecule APIs with poor solubility or permeability. Liam Critchley explores how pharmaceutical companies are using integrated formulation strategies – including amorphous solid dispersions, nanosizing and lipid carriers – alongside advanced data analytics and AI-driven approaches to accelerate discovery, enhance solubility and reduce development timelines for traditionally hard-to-formulate drugs.
AI now: What QbD and PAT missed
While AI is transforming pharmaceutical R&D and manufacturing, legacy frameworks like quality by design (QbD) and process analytical technology (PAT) have fallen short of expectations. Digital life sciences advisor Michael Louie, pharma AI start-up founder Nikolai Makaranka and Grace Cronin of Bristol Myers Squibb talk to Ellie Philpotts about exploring how AI could succeed where others stalled – if data quality, infrastructure and crossfunctional collaboration are prioritised from the start.
Cool heads, smart chains
Biopharma companies are harnessing AI and predictive analytics to transform temperature controlled logistics, with new entrants and innovations bringing advanced monitoring and- control solutions. Claire Read speaks to Jim Bacon, president of Stay Cool Logistics Consulting, and Phil Pluck, chief executive of the Cold Chain Federation, about why building internal expertise and infrastructure is vital to support data-driven decision-making.
Sustainability vs suitability
Temperature-controlled packaging is under scrutiny as the pharmaceutical industry seeks to balance safety, efficiency and sustainability. In this evolving debate, Sarah Harris explores the challenges and opportunities, drawing on insights from packaging expert Matthew Rogerson to highlight how innovation, regulation and circularity are shaping the future of cold chain design.
Integrating sustainability compliance
Pharmaceutical companies are increasingly looking at ways to make their drug delivery systems more sustainable in response to external pressure. But they also must comply with stringent regulations designed to prioritise patient safety. Kim Thomas asks Michaela Fuetsch, head of PT chemical and environmental legislation at Roche, how pharma companies are meeting the challenge of improving sustainability while adhering strictly to global regulatory frameworks.
Bio shocks
In the first half of 2025, global geopolitical tensions continued to rise, with resulting economic shifts as the biopharmaceutical market responded at pace. GlobalData’s ‘The State of the Biopharmaceutical Industry’ found out how industry professionals are closely monitoring the rise of anti-obesity medications, advancements in precision medicine and the transformative potential of artificial intelligence, all while grappling with supply chain challenges and regulatory changes.
Fine and speciality chemicals industry keeps its cool: Resilience and quality connections define Chemspec Europe 2025
The 38th International Exhibition for Fine and Speciality Chemicals has delivered a resounding success, proving that this industry thrives under pressure. Following a dynamic two-day run at Koelnmesse in Cologne, Germany, the event generated significant impact at a pivotal moment for the global chemicals industry. A total of 424 key suppliers from 23 countries showcased their chemical substances, bespoke solutions and manufacturing services to an exceptionally engaged trade audience, bringing together around 7,000 industry professionals in productive networking and business discussions.
FDA approves the Randox ConcizuTrace™ ELISA Companion Diagnostic (CDx)
Randox Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved the De Novo application for the company’s first Companion Diagnostic (CDx). This is a major achievement for Randox following over 3 years of innovative development and collaboration with Novo Nordisk. The Companion Diagnostic was developed as a new option for determining the amount of medication a patient with hemophilia has received.
Big names, big issues: Chemspec Europe 2025 to deliver strong insights and momentum at a pivotal time for the chemicals industry
From 4–5 June, the international fine and speciality chemicals industry will gather at Koelnmesse, Germany, for the 38th edition of Chemspec Europe – the sector’s leading sourcing hub for chemical innovation in pharma and industry. Set in vibrant Cologne, near some of Europe’s largest chemical parks and pharma sites, the event provides a perfect gateway to connect with international professionals in chemical development and manufacturing. Over two days, more than 400 key suppliers from 22 countries will share their expertise in fine chemicals, custom solutions, and specialised contract services – supported by high-level talks and regulatory guidance.
Seal the deal
Container Closure Integrity Testing (CCIT) is a necessary step in ensuring that the integrity of a container closure system will last until the end of a product’s shelf life. With the help of Christian Proff, senior verification engineer at Hoffmann-La Roche, Jim Banks examines the relative merits of commonly used physical CCIT methods, such as helium leak testing and CO2 headspace analysis, and how different techniques might evolve in the future.