Your supplier’s knowledge level and responsiveness are crucial in solving difficult R&D problems and proactively anticipating problems and challenges that may surface during scale up.
With 35 years of experience, we know that a true partnership is the only way to understand your current and future needs. LGC, Biosearch Technologies’ scientists are hands-on from the time of assay inception, positioning us to see potential challenges and adjust your design strategy to facilitate a seamless transition to scale up and avoid costly troubleshooting during production.
Component quality and consistency are vital throughout product design, manufacturing, regulatory approval and commercialisation. From avoiding uncertainty during early R&D to ensuring compliance with relevant ISO or other regulatory requirements, companies need to be confident that their overall product quality is supported by quality components.
LGC, Biosearch Technologies’ vertical product integration ensures comprehensive traceability for repeatable (lot-to-lot) and consistent (within lot) production, enabling robust, high-quality assays that support rapid regulatory approval and confident reliance on assay supply and performance.
If your supplier uses a “fixed” manufacturing platform, its ability to adjust for fluctuating variables such as yield, purity and performance when moving from small pilot to full-scale production batches will be limited. Moreover, accommodating your specific needs that lie beyond the fixed manufacturing platform might be a significant challenge.
The experience and flexibility of LGC, Biosearch Technologies’ production platform enables our chemists to fine-tune your design strategy at crucial steps during production, empowering us to reliably deliver the same consistent product regardless of scale, ensuring your needs are met.
Molecular diagnostics companies in the R&D phase will often look at initial cost as a key driver for component choice without considering the long-term implications of their decisions. However, examining the breadth and capabilities of a supplier’s portfolio is a key consideration in preparing for scale up and for successful long-term commercialisation.
LGC, Biosearch Technologies’ broad portfolio of quality, customisable assay components, along with our responsive manufacturing capabilities, rapid order turn-around, and on-time delivery, will help speed your product development and ensure confidence from start to finish.
Learn how experts evaluate suppliers and assay components by downloading this informative article. Harry Glorikian – a general partner at New Ventures Funds and a veteran board member and storied investor in MDx companies – discusses how to establish a macro plan for reaching diagnostic success based on real world insights with Sébastien Chapdelaine, Senior Director of R&D at a MDx start up company.