article
Manufacturing, Packaging & Logistics In-Depth Focus 2021
Articles in this in-depth focus explore how to promote patient access to breakthrough treatments across Europe and discuss some of the latest and greatest innovations in packaging.
List view / Grid view
Industry Insight
article
Formulation, Development & Delivery In-Depth Focus 2021
This in-depth focus explores recent developments in pharmaceutical stress testing and why collaboration is key in the development of cancer therapeutics.
article
Bioprocessing & Bioproduction In-Depth Focus 2021
In this in-depth focus, experts discuss how a future skills shortage may impact the biopharma industry and the key considerations when validating assays and analytical methods for ATMPs.
article
The registration of novel excipients
Here, Dave Elder discusses some encouraging progress in the development of novel excipients, highlighting what this means for the industry.
article
Many hands make light work: why the new Bespoke Gene Therapy Consortium is a godsend for ambitious biopharma teams
In late October, we learned that an exciting and ambitious new entity – the Bespoke Gene Therapy Consortium (BGTC) – had come into being in the US, designed to encourage the delivery of more gene therapies for rare diseases. The consortium is an interesting construct, headed and funded by the…
news
ABPI publishes new roadmap to aid in ATMP development
The roadmap clarifies the processes to develop advanced therapy medicinal products (ATMPs), providing guidance on key considerations.
article
Challenges and innovations shaping the bioprocessing industry
In this article, Robert Newman and Tom Fletcher explore how the bioprocessing industry has changed in the last 50 years and where the future may lead…
news
UK regulator publishes guidance on use of real-world data to support clinical trials
Two new guidance documents, the first in a series to published by the MHRA, outline considerations when planning a randomised clinical trial using real-world data.
article
Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
article
European Pharmaceutical Review Issue 6 2021
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
news
Regulators recommend remote inspections for use post-pandemic
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
article
Five marketing strategies for novel therapeutics
Long before the advent of Coronavirus, next-generation therapies were making headlines, but the successful development of COVID-19 vaccines, including mRNA vaccines, has now shone a spotlight on next-generation therapies. This offers a boost to the long-term growth projections for the advanced therapy medicinal products (ATMPs) sector. But although ATMPs hold…
news
Novel platform technology to enhance in-process monitoring of cell biomanufacturing
A new microfluidics tool, the Dynamic Sampling Platform, could improve biomanufacturing of cell therapies by reducing the cost of analysing bioreactor contents.
article
Technologies and tactics for accelerating end-to-end biologic drug development
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…
podcasts
EPR Podcast Episode 6 – Precision Medicine with Laetitia Decroix Guilloux and Edmond Chan, Janssen
Why are precision medicines important? What challenges face their development and manufacture? Where could they be in 10 years? Discover all this and more in this podcast with Janssen!
