When it comes to assay development and manufacturing, choosing the right Contract Development and Manufacturing Organisation (CDMO) is a critical decision that can significantly impact the success of your project. A CDMO’s expertise, capabilities, and approach can influence not only the quality of the final product but also the speed to market and regulatory compliance. Here are 10 key considerations
Taking an assay from development to commercial scale manufacture is a complex process. Can the formulation be stabilised? Do you have the regulatory approval? And not least, how do you plan for fluctuations in demand? Unless you plan for assay scale up at the design stage, it’s quite common to find that what works in development does not transfer smoothly
Deeside, Wales 9, May 2024: Biofortuna Limited, the specialist laboratory services and CDMO, has completed the acquisition of Cryoniss Ltd, underlining its commitment to support life-changing research and development across the global biotech and life sciences sector. The acquisition of Cryoniss brings expertise and infrastructure in temperature-controlled biological sample storage, strengthening Biofortuna’s existing stability storage capability and accelerating the growth
We would like to extend a big Biofortuna welcome to Corinne Niger and Sarah Sadler as they become the latest additions to our European sales team. Corinne joins us from a similar role at Oxford Nanopore and has extensive experience in sales development and project scientist roles. Sarah arrives from LGC Biosearch Technologies having previously been at Meridian Bioscience. Together
We are delighted to share the news that our custom lyo bead Development and Manufacturing service has been shortlisted for the 2023 Bionow awards in the category of Technical Service of the Year. Now in their 22nd year, the regional Bionow awards celebrate the innovation and impact of the Life Sciences sector. A panel of judges reviewed detailed case studies
Download our application note to see how the precision and consistency of lyophilised beads is retained when manufactured at scale.
If you have always manufactured your in-vitro diagnostic (IVD) assays in-house, it’s tempting to stick with what is tried and tested. After all, it has worked up until now, and in theory manufacturing in-house should result in the seamless integration of development, validation, regulatory submission, and subsequent large-scale output. And if all those processes are managed in one place, then