Development and Manufacturing

During assay development, the feasibility stage is often viewed as a simple proof of concept. Can the assay detect its intended target? Are the initial results promising? And while these questions are fundamental, promising results alone don’t guarantee a successful path to commercialisation. Many assays perform well during initial development but can encounter challenges later because reproducibility and manufacturing requirements

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Transferring a lyophilised assay from development to large-scale manufacturing is never a simple matter of just “scaling up”. The lyophilisation process introduces challenges surrounding equipment, formulations, stability, validations and quality control. Each of these must be carefully considered to ensure consistency, reliability and compliance. Consideration 1: Freeze Dryer Capabilities One of the most notable hurdles in assay transfer is equipment.

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The evolution of nucleic acid amplification techniques (NAAT) Since its development in the late 1980’s, PCR has been considered the gold standard for DNA amplification for molecular analysis.  However, the requirement for dedicated and costly instrumentation to provide appropriate temperature cycling control has limited the use of PCR mainly to laboratory settings. This bottleneck has led to the development ofRead more

Point of Care Testing delivers the accuracy of laboratory testing without the wait Speed is critical when diagnosing. Clinicians must treat or manage the issue quickly and effectively. This urgency is particularly vital in cases of viral infection. Will the patient need to go to hospital and, if so, do they need to be treated in an isolation ward? Should

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What is glycerol? Glycerol, also known as glycerin, is a colorless, odorless, and sweet-tasting viscous liquid that is hygroscopic and soluble in water. It is a simple polyol compound, consisting of three carbon atoms, each attached to a hydroxyl group (–OH). Glycerol is a byproduct of the soap-making process and the biodiesel production process, and it is widely used inRead more

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

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Lyophilizing critical reagents within diagnostic microfluidic cartridges can improve assay accessibility, increase shelf life and obviate the need for cold chain logistics. Moreover, when done so combining modern single-dose technologies and pick and place automated assembly, the process can also significantly reduce the cost-per-test of near-patient diagnostics. In this blog we examine the process in detail, and outline the advantagesRead more

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

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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

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