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Current Edition

Issue 8, Volume 3

Current Features

Current Features

Turning the Temperature Up on Cold Chain Logistics

As biopharma therapies become more sensitive, costly and complex, traditional compliance frameworks are no longer enough. Real-time visibility and IoT innovation...
7 October 2025 Current Features
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Current Features

Developing Endotoxin Limits, Risk Assessment and In-process Testing for CGT Products

Cell & Gene Therapy (CGT) products face a unique challenge in the required pyrogen testing for injectable wares. Since this test was written for conventional...
7 October 2025 Current Features
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Current Features

Why Renting Product Inspection Systems Makes Strategic Sense for Pharma Manufacturers

Production lines don’t pause for procurement. When pharmaceutical manufacturers face a sudden spike in demand, new quality control requirements or equipment failure,...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

The Importance of Mass Spectrometry 

Mass spectrometry (MS) has long been a cornerstone analytical technique in the pharmaceutical and biopharmaceutical industries. Its ability to provide detailed molec...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Plan, Lead, Deliver: A Framework for Regulatory Writing Success 

Q: Is your team simply writing a dossier, or are they following a clear strategy?A: The most effective teams do both, but strategy should come first. Preparing a sub...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Navigating FDA and USP Regulatory Guidance with LAL Reagents for Bacterial Endotoxin Testing

Navigating the regulatory landscape of the Bacterial Endotoxin Test (BET) involves a thorough review of guidelines from regulatory agencies such as the FDA, USP, and...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Edition

Issue 8, Volume 3

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Current Features

The Impact of Clinical Development Decisions on Time to Market and Development Risk in Oncology 

Key Findings• Every month a programme can accelerate to market adds an estimated $5–6M of net present value per billion dollars of peak year sales• We have identifie...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Modelling the Bone Marrow Niche In Vitro: A Roadmap for Drug Development 

The bone marrow niche provides a tightly controlled setting where cellular interactions, biochemical signalling, and mechanical stimuli collectively shape the fate o...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Challenging Targets in Antibody Discovery

Antibodies represent a rapidly growing therapeutic modality, demonstrating clinical success over a wide variety of diseases, including cancer, autoimmune disorders, ...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Building the Foundation for Biopharma 4.0 Through Strategic Digital Transformation

What is Biopharma 4.0? Biopharma 4.0 refers to the next-generation modernisation approach to biopharmaceutical development, manufacturing, and quality. It integrates...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

TPDs: Developing the Next Generation of Oral Therapeutics

Targeted Protein Degraders (TPDs) are transforming the landscape of modern drug discovery and development, introducing a ground-breaking method for tackling diseases...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Harnessing the Power of Generative AI: Transforming Life Science Manufacturing

The life science industry faces the challenges of developing and delivering life-changing medicines at an accelerated pace, all while maintaining quality and safety ...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Building a Global Data Foundation for Scaling AI 

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...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Regulatory Impact Assessment is Obvious Next Target for GenAI, Experts Conclude 

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...
17 July 2025 Current Features | Volume 8 Issue 2
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Current Features

Avoiding the Domino Effect: How Smarter Temperature Control and Excursion Management Prevent Clinical Trial Disruptions 

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...
17 July 2025 Current Features | Volume 8 Issue 2
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Company Profiles

insideReg
Company Profile

insideReg

InsideReg is a specialist regulatory affairs consultancy, with full-service capabilities, founded in 2018 by ex-MHRA Assessor and CHMP Expert, Dr Laura Millichamp. I...
23 July 2025 Company Profile | E-M
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International Biopharmaceutical Industry

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