Taking cell and gene therapies from idea to commercialisation
David Vincent, Process Development Lead at eXmoor Pharma, details some of the critical steps that form the manufacturing strategy for providers of cell and gene therapies.
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Manufacturing, Packaging & Logistics In-Depth Focus 2021
Features in this in-depth focus highlight some of the important developments in the cell and gene therapy market, as well as the key manufacturing strategies to consider when taking them from concept to commercialisation.
QA/QC & Environmental Monitoring In-Depth Focus 2021
In this in-depth focus, learn how to overcome interfering factors when using LAL for endotoxin testing and discover how the implementation of a new scrubs system benefited an aseptic production facility.
Formulation, Development & Delivery In-Depth Focus 2021
Featured in this in-depth focus: why improving dosing accuracy with infusion pumps requires users to have a better understanding of the equipment and how nanomedicines could be instrumental in improving skin and nail diseases.
Bioprocessing & Bioproduction In-Depth Focus 2021
Download this in-depth focus to discover why shifting away from traditional bioproduction and drug delivery systems could allow antibodies to reach their full potential and how Raman spectroscopy can give useful insights into your processes.
Scrubbing up the environment
Here, colleagues from University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) share the beneficial impact of reduced cleanroom environmental contamination following an upgrade to their facilities and procedures.
Bacterial Endotoxin Test using LAL methodology: overcoming interfering factors
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
European Pharmaceutical Review Issue 4 2021
In our latest issue, features explore the use of nano formulations to improve skin and nail drug delivery, how to take cell and gene therapies from concept to commercialisation and what strategies you can use to overcome interfering factors in LAL bacterial endotoxin testing. Also in this journal, find out…
Meeting the challenge of cost-effective OTC drug manufacture with powder testing
Sharper manufacturing practice is often essential to rigorously optimise production economics and compete effectively in the over-the counter (OTC) marketplace. This article describes the application of powder testing to improve the manufacturing efficiency of OTC products detailing work by Pfizer and GlaxoSmithKline (GSK), companies with extensive OTC portfolios.
ebook: Waiving intellectual property rights for COVID-19-related interventions and technologies: a comprehensive guide
This ebook explores the intellectual property rights waiver for COVID-19 treatments, vaccines, diagnostics and technologies, its potential ramifications for the drug development industry and potential solutions for overcoming COVID-19 vaccination inequalities.
Assessing pharma’s readiness for digital product information management
With new EU IDMP guidance now published, how can pharma firms reap the benefits of a digital product information management future? Here, Iperion’s Adnan Jamil explains.
Collaboration and integration to progress clinical research
Here, Lucinda Cash-Gibson and Francesco Patalano discuss why the pharmaceutical industry is collaborating to develop protocols for patient-centric integrated platform trials and what the clinical research industry may look like in future.
FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
What lies ahead in the regulatory pipeline for medical device manufacturers? A compliance strategy to meet the 2023 Class II deadline
Here, Kallik’s Bob Tilling discusses the importance of acting early and embracing technology to comply with EU MDR labelling requirements, citing challenges from the recent scramble by many Class III medical device manufacturers to meet their May 2021 deadline.
Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
