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.
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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.
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.
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.
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…
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…
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.
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.
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.
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.
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.
Cyber hackers target businesses of all shapes and sizes, but the pharmaceutical industry remains a prime target, especially as these companies undergo digital transformation and move high value data online. But how can the industry protect itself from the threat of cyber attack? Jack Garnsey, Product Manager at VIPRE SafeSend…
Here, David Leitham, senior vice president and general manager at AspenTech, explains how implementing PAT pushes the industry towards Pharma 4.0.