A start-up clinical diagnostics company had been recommending commercially available systems for RNA purification to prepare samples for testing in a molecular diagnostics assay to be marketed to clinical laboratories. However, the commercially available systems were not giving the desired results. They approached Promega about manufacturing an RNA purification system for them.
We provided test materials and offered suggestions for optimizing results. The components were manufactured to the customer's specification and specific components were sourced to meet the customer's needs for the finished kits. Promega's custom manufacturing team also worked to provide the required bottles, labels and packaging materials for the finished kits.
To meet the specialized requirements for getting a sample preparation kit to market, Promega provided multiple product lots to support the customer's development work and clinical trials, and helped the customer develop and implement a product-specific validation plan for cGMP manufacturing of the completed sample preparation kit.
This customer is now working with Promega on a new initiative to incorporate additional components for downstream analysis to create a sample-to-answer kit.
A global molecular diagnostics company was developing a multiplex amplification-based clinical assay. Historically, the customer purchased Taq DNA Polymerase and dNTPs separately from another supplier to manufacture a master mix that was provided as a component in their kit.
We offered them an opportunity to customize a PCR master mix based on their formulation that would work well for a multiplexed PCR format at a competitive price per reaction.
Understanding that conditions need to be optimized with a new supplier, Promega formulated an evaluation batch of master mix specifically for testing and optimization purposes. The PCR Master Mix worked well in the customer's hands, even for difficult samples.
Promega capabilities allowed the manufacture of enough Master Mix for an entire year's supply in a single batch, allowing the customer to reduce the validation requirements for each newly requested shipment.
Furthermore, we were also able to accommodate prescheduled shipments of this single lot throughout the year, increasing the simplicity of the ordering process.
A major research institution placed a large order for CellTiter-Glo® Cell Viability Assay reagents, which are traditionally shipped with the individual glass bottles each wrapped with bubble wrap. For customers ordering extremely large quantities (e.g., a year's supply), unwrapping each individual bottle can be tedious and time consuming.
The Promega Field Application Specialist for the account worked with the custom operations team in Madison, WI, to see if packaging could be customized for this large order to reduce packing materials, ensure safe delivery of product, and save the customer time at unpacking.
The operations team worked to design a new packaging configuration that met Promega's stringent packaging requirements and protected the product from damage, as demonstrated by testing using our in-house shipping equipment. As a result this large order shipped in the new packaging, and the customer was able to unpack the entire shipment in under an hour.
A global molecular diagnostics company wanted to improve their existing assay platform by offering easy-to-use lyophilized reagents in single-reaction units. Their existing supplier was unable to meet their formulation requirements, resulting in a frustrating and costly situation. Promega provided small-scale batches of lyophilization–compatible formulations for the reagents for the customer to evaluate, with the capability of cGMP manufacturing of larger scale batches for use in the finished product. Our R&D scientists worked with the customer's R&D group to optimize custom components, including GoTaq® polymerase and buffers their specific multiplex application. Within several months, cGMP-manufactured custom components were available for the customer.