Drug Product Process Development
We at Plough Center with the built-in flexibility, adaptability and pharmaceutical excellence of commitment for continuous improvement book of business, we can enhance the evolving process to maximize its effectiveness by increasing manufacturing efficiencies, reducing overhead costs.
Conventional drug-product process development, optimization and validation involves empirical approach with off-line quality testing of process attributes. This approach is really file first learn later strategy. At Plough Center, we consider the above approach inefficient and unreal in real world variabilities. At Plough Center, we follow a proactive and dynamic approach based on Quality by Design (QbD).
QbD is modern scientific approach that formalizes process design, automate manual testing and streamline troubleshooting. QbD enables us to understand the critical process parameters early in an evolving process refinement. It also help us to make risk based assessment of process safety and potential hazard ratio. QbD approach using the Process Analytical Technologies (PAT) through engineering Design of Experiments (DOE) is extremely useful for clearly defining Critical Quality Attributes (CQA) and Quality Target Product Profile (QTPP) of the product by early understanding of drug product dose, delivery methods. CQA and QTPP in combination derive robust specifications and impurity profiles that are within the acceptance criteria. These product design goals are very useful to create a process design space for process optimization and subsequently the controlled process framework called “validation window” with acceptable ranges of critical process parameters.
We understand the underlying challenges of our clients and their organizational challenges due to unallocated resources, lacking in-house expertise and swiftly changing priorities. So let us take your burden away and in return provide you a robust process for manufacturing the drug-product dosage form that accelerates FDA review process with less number of queries. The gain knowledge you receive from QbD strategy enables expedited drug approval, minimize out of specifications (OOS), deviations and batch failure.
In addition to our in-house capabilities and intellectual power and formulation expertise, we are strategically headquartered surrounding intellectual power houses of scientific departments and your accessibility in unlimited for your applications. At Plough Center, leveraging the deep understanding of molecular properties, most advanced formulation technologies, and Integrated delivery systems available to us, we are confident to develop any of your R&D innovations into your development program or beyond as we see sky as our limits.
Our business model is constructed with the essentials of earned value management. We understand the value of your resources and timelines and any noticeable variance in quality will have direct impact on cost and schedule. If we can proactively plan your values with optimal measure of our performance, we could address "vital few" from "trivial many." That is the Plough Center Difference.