Whether developing new, ground breaking drugs or generic formulations, both the time and cost associated with pharmaceutical development is significant.
Malvern is focused on providing well designed, innovative analytical instruments, which follow the QbD (Quality by Design) ethos, in the fields of drug discovery, chemical and formulation development and pharmaceutical manufacturing.
Malvern can help with many aspects of QbD implementation; providing measurement technologies which have been designed, developed and tested following QbD principles, providing instruments, software and documentation to facilitate rapid method development, validation and transfer. We understand analytical instrument deployment and on-going support in a regulated environment to help you save time and money in bringing your product to market.
We understand what is involved in the development and manufacture of a drug product and the requirements to measure the Critical Material Attributes and Critical Quality Attributes (CQAs) affecting the Critical Process Parameters (CPP) in the manufacturing process.
Malvern’s value is in the breadth of characterization tools and application understanding that can be used to help accelerate pharmaceutical development. Malvern can implement systems that provide information on several Critical Material Attributes (CMAs) in one analysis, such as particle size, shape, and chemical identity or molecular weight, size and concentration. Whether characterizing the particle size and morphological properties of a novel Active Pharmaceutical Ingredient (API) or the suspension stability or rheological attributes of an New Chemical Entity (NCE), work flow efficiencies can be achieved when common platform technologies are utilized.