The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999s guidance.

The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999s guidance.

From artificial intelligence-powered identification tools to global fungal mapping projects, technology is redefining one of humanity’s oldest interactions with nature: the search for wild mushrooms.

Quality risk management should be a priority for pharma and healthcare. Here Dr Tim Sandle gives his advice on what to consider when conducting risk assessments

A cleanroom surface may appear dry, smooth, and visibly clean, yet this does not necessarily mean that it is microbiologically inert. Microorganisms deposited onto stainless steel, glass, polymers, fl...

Shop items by BabblingBacteria.

A cleanroom surface may appear dry, smooth, and visibly clean, yet this does not necessarily mean that it is microbiologically inert. Microorganisms deposited onto stainless steel, glass, polymers, fl...

pharmaceutical microbiology, quality assurance, healthcare, cleanroom, contamination control, microbiology, tim sandle, sterility, disinfection. GMP

BriaCell Therapeutics is developing off-the-shelf cellular immunotherapies for patients with advanced cancers. Its lead candidate, Bria-IMT, is in a Phase 3 trial for metastatic breast cancer, while the Bria-OTS platform is being expanded to prostate cancer, melanoma, and other solid tumours. Using tissue matching via a saliva test, the platform aims to provide accessible precision medicine without the delays and costs of personalised therapies. Recent FDA clearance for Bria-PROS+ supports the technology’s broader clinical potential.

Merck rapid microbiology

By cataloguing and showcasing Africa's Phase 1 clinical trial capacity, CEPI and Africa CDC are helping build the foundations for faster and more equitable outbreak responses in the future. This indicates that Africa is increasingly positioned not merely as a recipient of medical innovation, but as a central contributor to the development of vaccines and other life-saving interventions.

As cybercriminals continue to weaponise artificial intelligence, consumer education may become just as important as technological protection. Here, cybercrime is becoming more personal. Attackers no longer simply target devices and networks. Increasingly, they are targeting trust itself.

The robotic revolution may involve more than robots becoming smarter. It may also depend on giving them better tools. And among the most promising of those tools could be a laser pulse lasting just a few quadrillionths of a second

Human immunity and the microbiome

AI can reduce healthcare administration, easing workforce pressures and giving clinicians more time for patient care. When applied responsibly, it can streamline prior authorisation, improve efficiency and transparency, accelerate treatment access, and support better outcomes for patients and healthcare providers.

Infectious diseases do not respect borders, and preparedness cannot be achieved in isolation. The emergence of freezer-free RNA vaccine technology may therefore represent more than a technical advance. It may signal a shift towards making some of the world's most sophisticated vaccine technologies genuinely global in their reach.

Artificial intelligence, cloud computing and digital transformation will continue to shape the global economy. The challenge is ensuring that these technologies evolve in parallel with clean energy deployment, emissions reductions and transparent climate performance.

Bacteria x artificial intelligence

The discovery that acid mine drainage remediation may generate substantial long-term carbon emissions, in Canada and many places world-wide, serves as a reminder that environmental accounting remains a work in progress. Critical minerals will remain central to the clean energy transition, but ensuring that these resources are produced sustainably requires continuous examination of their true environmental costs.

The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?

In the era of AI, trust is set to become a key competitive advantage. This is as organisations seek to protect customers while delivering seamless AI-powered digital experiences.

There is little doubt that AI agents are improving rapidly. Capabilities that seemed experimental only months ago are becoming commercially available. Research, scheduling, document handling and workflow automation are already demonstrating measurable productivity benefits. However, findings indicate that autonomy remains constrained by practical realities.

Few pharmaceutical quality concerns have had as widespread an impact on the industry in recent years as nitrosamine impurities. Since their unexpected detection in marketed medicines in 2018, nitrosam...

Join Microbiology and contamination control expert Dr Tim Sandle for issue 48 of the latest regulatory news from around the pharmaceutical industry

Artificial intelligence will undoubtedly continue to transform society. New models will become faster, more capable and more deeply integrated into everyday life. Yet the importance of philosophical inquiry is likely to grow alongside technical progress. Questions concerning trust, responsibility, consciousness, fairness and human agency cannot be answered by algorithms alone.

As the demand for faster, more energy-efficient computing continues to grow, discoveries of this type highlight the importance of fundamental materials science. Innovations in artificial intelligence, data storage and advanced electronics may ultimately depend on understanding the subtle interactions occurring deep inside materials that, at first glance, appear deceptively simple.

YouTube video by Tim Sandle

For those who regularly engage in long conversations with the family dog or provide running commentary to a cat, new research delivers reassuring news: you are certainly not alone, and your pet talk may be more scientifically interesting than you ever imagined.

pharmaceutical microbiology, quality assurance, healthcare, cleanroom, contamination control, microbiology, tim sandle, sterility, disinfection. GMP

As neuroscience continues to move beyond simplistic explanations centred on neurotransmitters, the future of depression treatment may increasingly involve restoring the brain’s remarkable capacity for resilience and renewal.

As humanity ventures farther into space, knowing where you are may become just as important as knowing where you want to go. Thanks to NASA’s Starling mission and the successful demonstration of FALCON, spacecraft are now one step closer to finding their own way.

As Canada and the wider world continue to confront evolving infectious disease challenges, the contributions of these emerging researchers demonstrate that the next wave of solutions is already taking shape within the laboratory.

Many published studies assess algorithms retrospectively, using historical datasets rather than active patient workflows. While useful, retrospective studies do not fully capture how clinicians…

The smartest way for AI to understand a complex world, and to provide detailed 3D images, is by allowing multiple experts to work together.