Issue: Vol. 42

Building your bioassay data package

10 June 2024 No Comments

Bioassays are a cornerstone of drug development, providing insight into the mode of action (MoA), potency, and potential immunogenicity of biologic therapeutics. These assays are utilized at various stages from early discovery to clinical trials. However, with so many variations that impact multiple outcomes, selecting the right bioassay is more than a matter of preference – it’s a potential make-or-break moment for a project. As advances in instruments and techniques continue to broaden the bioassay toolbox, this article focuses on what stage appropriate assays can be selected to drive our drug development process forward with increased chance of clinical success.

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Nucleic acid therapeutics through discovery and manufacturing to digitalization

10 June 2024 No Comments

This article explores the dynamic field of nucleic acid therapeutics, highlighting its evolution from targeting specific genetic disorders to addressing multifactorial diseases, incorporating insights from industry experts collected through interviews. It refers to the developmental trajectory of these therapies, including key scientific breakthroughs, advancements in drug delivery systems like GalNAc-siRNA conjugates, and the ongoing challenges in manufacturing scalability and regulatory compliance. Furthermore, the article discusses the integration of digital technologies that enhance the efficiency and effectiveness of research and development processes.

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Digital solutions for advancing your mRNA workflow Paperless manufacturing reduces the documentation burden on small-scale mRNA manufacturing

10 June 2024 No Comments

For emerging mRNA-based drugs that can sometimes require small, intensified batches, paperless manufacturing—using automated, digital data management instead of paper-based recordkeeping—offers even more competitive advantages. In this article, we address the benefits of paperless manufacturing to both small and emerging companies alike, why it’s essential to incorporate a digital strategy early in the manufacturing process, and how a digital solution for mRNA manufacturing can help small batch manufacturers more effectively produce these soon-to-be essential medicines.

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Cash in on your hard work: dos and don’ts when selling your chemical business

14 May 2024 No Comments

The article delivers simple and yet powerful steps to take when selling a chemical business. It emphasizes the pivotal role of meticulous preparation and the power of having external M&A professional guidance in finding the ideal buyer to maximize your company’s selling price. It underscores the crucial role of finding and quantifying synergies in each buyer’s hand to drive price, and it offers a blueprint to differentiate a seller’s approach between strategic and financial buyers. This is an actionable, common-sense agenda to amplify your company’s worth by turbocharging operations and slashing debt pre-sale. The article concludes by emphasizing the vital importance of showcasing the value hidden in your commercial portfolio and innovation pipeline, highlighting the importance of demonstrating future growth and commanding a higher price. These invaluable insights will help you sell your business at a premium price. Ignore it and risk leaving half of the money on the table.

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Countdown: Time pressure for sponsors to move trials to the CTR

14 May 2024 No Comments

Time is fast running out for transition of ongoing clinical trials in the EU to the Clinical Trial Regulation and submission through the Clinical Trial Information System (CTIS).
The article will explore the challenges and implications for clinical trials that have yet to transition to the CTR. It will delve into key steps and strategic planning to manage the transition and address amendments to existing trials.

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