Sustainable pharma packaging: breaking down the barriers to adoption
Here, Origin’s Rich Quelch explores how pharma can adopt more sustainable packaging practices while balancing consumer safety.
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Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
Using RWE in rare disease drug development: effective innovations with historical controls
With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
Is localisation the answer for pharmaceutical supply chain resilience?
Highlighting the findings of a recent supply chain report, EPR’s Hannah Balfour discusses measures pharmaceutical suppliers may adopt to establish demand- and crisis-resistant supply chains. Commenting on the findings, Ernst & Young Global Limited colleagues Famke Krumbmüller, Derron Stark and Olaf Zweig elaborate on the impact and lessons learned through…
Pharmacovigilance deep dive: risk minimisation measures
Here IQVIA’s Dr Sophie Jouaville discusses the importance of risk minimisation measures, how their effectiveness can be assessed and why transparent reporting of these effectiveness studies is crucial.
Managing the next pandemic: the role of nasal vaccine administration
In this article, Recipharm’s Joe Neale explores how learnings from the COVID-19 pandemic can be applied in the future and asks how nasal administration could help our fight against tomorrow’s outbreaks.
Personalised culture media solutions support timely biopharmaceutical manufacturing
FUJIFILM Irvine Scientific excels in facilitating improved upstream cell culture and process development for the production of therapeutic proteins with custom media. Here, Burga Kalz-Fuller, Product Manager for Custom Media Services at FUJIFILM Irvine Scientific, answers frequently asked questions about personalised cell culture media solutions.
API nitrosamines: method sensitivity issues
Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.
Oncolytic viruses: past and present
It is difficult to treat cancer effectively without causing adverse side effects. In this article, Dr Li, Clinical Assistant Professor at the State University of New York and Board Director of ExonanoRNA, describes how an old strategy that never got off the ground has finally been leveraged to deliver safe,…
Securing every dose with an edible security technology for safe medicines
The problem of counterfeit medicines is becoming a tremendous burden to society. An edible security tag affixed to each medicine can provide track and trace measures with dose information and on-dose (in-dose) authentication. Furthermore, it serves as a last line of defence against illicit pharmaceutical products. Young Kim, Associate Head…
Accelerating timelines for development and manufacture of multi-specific antibodies
The critical need to rapidly develop new biological therapeutics was emphasised during the COVID-19 pandemic, prompting a sea-change in the speed with which development of complex biological medicines occurs. In parallel, the increasing demand for new molecular formats, such as multi-specific antibodies, to tackle a wide range of disease modalities…
The EU HTA regulation: a new frontier for access to innovative technologies
A new health technology regulation is due to be applied to help EU countries determine the effectiveness of novel technologies and decide on pricing and reimbursement by health insurers or health systems. Here, Professor Vincenzo Salvatore and Giuseppe Ragucci from BonelliErede reflect on what this means for the UK and…
Efficient water determination accelerates API development
Contract development and manufacturing services for active pharmaceutical ingredients (APIs) must meet the requirements of customers and regulatory bodies alike. In the process control lab of the CARBOGEN AMCIS AG pilot plant in Bubendorf, Switzerland, accurate and efficient Karl Fischer titration workflows for water determination offer fast and reliable decision…
Towards ‘smart’ vaccine development and manufacturing
The coronavirus pandemic encouraged biopharmaceutical companies to adopt smarter approaches to vaccine development. Here, Vishnu Kumar and Soundar Kumara from Pennsylvania State University, and Vijay Srinivasan from National Institute of Standards and Technology (NIST), explore the emergence of platform-based vaccine technologies and their potential expansion to treat other life-threatening diseases.
Progress in the implementation of biofluorescent particle counters
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
