Issue: March / April 2023

How to transition to e-labelling – practical first steps

3 May 2023 No Comments

E-labelling provides patients and healthcare professionals with up-to-date product and safety information. Schlafender Hase’s Dr. Jutta M. Hohenhörst discusses the benefits of e-labelling for the medical device sector and provides some practical tips for getting ahead with processes, procedures and solutions that deliver efficiencies across today’s labelling landscape, and add value for patients.

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Next-generation approaches to statistical significance

3 May 2023 No Comments

Biopharma Excellence recently hosted a panel discussion featuring experts in biotech and the evolving regulatory environment to discuss the challenge of achieving statistical significance with novel and highly targeted therapies.

Daniel O’Connor of the UK’s MHRA, with a remit of Innovation Acceleration within a regulatory context, noted that the challenge of achieving statistical significance when target populations are tiny is nothing new, but conceded that randomised trials aren’t always viable – especially with very rare conditions. He urged drug developers to seek scientific advice before finding workarounds.

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Sustainability – What Does it Mean for Excipient Makers and Users

3 May 2023 No Comments

IPEC, an industry association of manufacturers, distributors and users of excipients is about to publish an updated draft version of its Excipient Information Package – User Guide and Templates. This new version will include a new part to facilitate and standardise the exchange of Sustainability information covering the very broad range of aspects dealing with Corporate Social Responsibility and Environment, Social and Governance.
This article provides a heads-up and a call out for your feedback when a draft version is ready for review.

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Bexagliflozin

3 May 2023 No Comments

Bexagliflozin (EGT1442), sold under the brand name Brenzavvy by TheracosBio, is an antidiabetic medication used to improve

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Maximising supplier controls to ensure optimal quality and safety

28 April 2023 No Comments

As the global Life Sciences market experiences ongoing disruption to international supply chains, this has created turbulence and consolidation for brands and manufacturers as they grapple with the complexity of ensuring safety and quality. As companies strive to build confidence in their end-to-end safety profile, Arriello’s Helen Lowe examines how they can ensure quality without boundaries.

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Quality matters: Challenges in 2023 across the life sciences supply chain

28 April 2023 No Comments

New waves of innovation in Life Sciences, and a redoubled effort by regulators to maintain patient safety, are placing increased pressure on drug and device manufacturers to assure the consistent standards across manufacturing processes, systems and supply-chain partnerships. After practical supply chain issues in 2022, added to the impact of continued medicinal/device innovation, 2023 will bring new regulatory changes linked to process digitalisation and automation. REPHINE’s Dr. Eduard Cayón discusses the implications.

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PAT evolved As Pharma 4.0 becomes reality, there is more to PAT than QC/QA

28 April 2023 No Comments

Process Analytical Technology (PAT) has undergone rapid developments since its foundation, substantially redefining how it can be realised and the gains it can deliver to companies in the (bio)pharmaceutical sector. Thanks to key advances in digital technologies, it is now possible to enhance more than quality control and assurance (QC/QA) activities. Simultaneously, as companies take steps forward to succeed in the creation of Industry 4.0 applications, they are shaping new frameworks and driving new trends. Interoperability and convergence to realise the Industrial Internet of Things (IIoT) is one of the most prominent aspects that future-oriented PAT solutions are addressing. Similarly, advanced data analytics capabilities to improve process control and equipment condition monitoring in addition to more automated decision-making to drive responsiveness on the shop floor and in the laboratory as well as inter-facility standardisation are also in high demand and supported by the latest PAT applications.

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