Market Reports

Reimagining biosimilars: faster access, stronger supply, sustainable healthcare

Outdated development models, uneven adoption and policy barriers are holding Europe back. Dr Kevin Robinson (KSR) spoke to Matt Erick (ME), Head of Advanced Markets at Biocon Biologics (pictured), to discover how the industry can close the biosimilars void and unlock billions in savings

Overcoming the hurdles of strategic market expansion

Ramprasad Kaparaboyena, Regulatory Affairs Manager and QP for Pharmacovigilance at Gaelic Laboratories, discusses how to overcome the challenges of expanding your pharma market into new global regions

Building a beta-lactam powerhouse: Gaelic’s strategic leap with Athlone

In December 2025, Gaelic Laboratories, a world-class manufacturer of beta-lactam (penicillin) products, acquired Athlone Laboratories, another leading developer and supplier of oral dose beta-lactams

From data to decisions: applying criticality and failure probability in process risk mitigation

This article presents an exploration of how structured, data-based methods enhance quality control, optimise specifications and improve process robustness throughout the product lifecycle

Stop reviewing good data: review‑by‑exception for chromatography QC

Labs spend hours confirming routine chromatograms while real risks hide in plain sight; regulators support a better path if data are captured and surfaced correctly, notes George Van Den Driessche, Data Science Product Manager at TetraScience

From stockpiles to smart supply chains: how industry wants to fix Europe’s drug shortages

An EU-level stockpile may work, but only if it’s flexible, closely monitored and built with logistics in mind. Industry players say drug security will depend less on volume and more on data, digital oversight and early collaboration throughout the supply chain

QInscribe unveils AI-powered medical writing to revolutionise regulatory submissions

New medical writing service provider QInscribe reduces the time to generate a draft clinical study report (CSR) by 90% with a generative AI solution

UK pharma shifts as Merck and AstraZeneca scale back: can CDMOs fill the gap?

Recent major site withdrawals and investment pauses have raised concerns about the UK’s industrial strength. But CDMOs say agility, innovation and technical expertise could redefine how and where drugs are made

Developing strategies for robust chemistry, manufacturing and controls execution for advanced biologics

Chemistry, manufacturing and controls (CMC) is a fundamental discipline for complex drug development projects. It must be rigorously implemented to navigate stringent regulatory requirements before drug approval and commercialisation

How CRDMOs are shaping the next generation of antibody-drug conjugates

To explore how CRDMOs are leading innovation in ADC development, Dr Kevin Robinson spoke with Srivats Rajagopal, Senior Director, Cell and Protein Sciences, Biology Solutions at Aragen Life Sciences, about key technological advancements and evolving partnership models that are redefining what it means to outsource in this space

NICE recommends enfortumab vedotin with KEYTRUDA for adults in England/Wales with untreated metastatic urothelial cancer

The results from the Phase III study EV-302/KN-A39 showed nearly a doubling of survival rates in patients compared with those who received platinum-based chemotherapy, which is the current standard of care in the UK

Start with the end in mind: the role of materials control in early CMC strategy for cell therapies

Cell and gene therapy products are complex in their design, nature and mode of action. Because of this, the road to market can be a challenging one; littered with variables and failures, what might have been a valuable treatment often fails to reach much-in-need patients

Empowering patients with self-administration drug delivery devices

Incorporating self-administered drug-device combination products into clinical trials benefits patients and manufacturers alike, reports Bill Welch, Executive Director of Market Development at PCI Pharma Services

Excipients step into the spotlight with sustainable and nano solutions

How multifunctional and natural materials are reshaping formulation science

How onco-HPAPI manufacturing is adapting to a new era

The oncology landscape is undergoing a quiet but powerful shift. Pharmaceutical companies, once focused primarily on novel compounds, are now increasingly exploring repurposing opportunities with existing high-potency oncology APIs (onco-HPAPIs)

Outsourcing in pharma: a comprehensive guide to strategic advantages and considerations

Outsourcing in pharma drives agility, compliance, and efficiency—NSF delivers expert audits, training, remediation, and embedded support

Poolbeg granted FDA Orphan Drug Designation for POLB 001

The US FDA grants orphan status to support the development of medicines for rare disorders affecting fewer than 200,000 people in the US

From data silos to streamlined connectivity: how biopharma can prepare for ESMP

Sponsors that centralise their product information will not only help to pre-empt drug shortages but also improve their capacity for collaboration with connected systems and data

Freeze drying ADCs: points to consider for industrial applications

As antibody-drug conjugates gain momentum in the pharmaceutical industry, manufacturers are increasingly looking to implement safe and effective process trains to produce them. Lyophilisation experts at GEA Pharma & Healthcare assess some of the most critical challenges and how to overcome them

The ABCs of ADCs: manufacturing ultra-high potent active ingredients

Senior Technical Manager at Sterling Pharma Solutions, Matt Miklas, presents a pragmatic approach to the safe and cost-effective production of highly potent pharmaceutical molecules, including antibody-drug conjugate (ADC) payloads

Why potency assays are a crucial consideration for CGT manufacturers

Potency assays can enhance the efficiency of cell and gene therapy development and commercialisation, while also bringing down costs

How iPSCs can bridge the translational gap in neuroscience

Affecting more than one in three people, neurological disorders have a vast impact on global health while exacting a tremendous cost, reports Dr Max Mirza, Vice President of Neuroscience Drug Discovery at Sygnature Discovery

Clinical trials: current insights and future perspectives

To keep up with the ever-evolving landscape of clinical trials, companies must conform to regulations and consider how to make the study process patient-centric

Recombinant versus synthetic peptide synthesis: the perks and drawbacks

Since the introduction of novel peptide drugs into the market, the demand for polypeptide manufacturing has significantly increased, reports Dr Philipp Markolin

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    Overcoming the hurdles of strategic market expansion Ramprasad Kaparaboyena, Regulatory Affairs Manager and QP for Pharmacovigilance at Gaelic Laboratories, discusses how to overcome the challenges of expanding your pharma market into new global regions
  2. You need to be a subscriber to read this article.
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    Reimagining biosimilars: faster access, stronger supply, sustainable healthcare Outdated development models, uneven adoption and policy barriers are holding Europe back. Dr Kevin Robinson (KSR) spoke to Matt Erick (ME), Head of Advanced Markets at Biocon Biologics (pictured), to discover how the industry can close the biosimilars void and unlock billions in savings
  3. Reading and understanding vendor-supplied tablet drawings Understanding the tablet drawings supplied by tooling vendors is a meaningful way to learn more about your product, reports John Norman, Technical Service Representative, Natoli Engineering Company
  4. Peak identification by LC/MS: Automation versus analyst High pressure liquid chromatography/mass spectrometry (LC/MS) is an important technique that facilitates the correct and accurate identification of impurities in pharmaceutical products and intermediates
  5. Freeze drying ADCs: points to consider for industrial applications As antibody-drug conjugates gain momentum in the pharmaceutical industry, manufacturers are increasingly looking to implement safe and effective process trains to produce them. Lyophilisation experts at GEA Pharma & Healthcare assess some of the most critical challenges and how to overcome them

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