Areas of Expertise
Formulation Development
Business Process Optimization
Process Risk Assessments
Project Leadership
Tech Transfer
Process Validation
Scientific Writing
Process Characterization
Formulation Development
Our formulation development process includes proven strategies to address the unique challenges associated with stabilizing therapeutic proteins. Driven by the Target Product Profile, we will guide your product through each stage of development.
Project Leadership
Working with your cross-functional team, leadership and project management we will effectively guide your project all the way from candidate selection to commercialization.
Scientific Writing
It isn’t enough to conduct research — you need to be able to present your findings in a way that’s easy for all to understand. We will prepare abstracts, posters, regulatory documents, templates, and other technical documents tailored to your audience.
Business Process Optimization
Business processes tend to grow organically from the bottom up, often resulting in inefficiencies when it comes time to perform an activity such as writing a dossier or conducting a risk assessment. We will evaluate your processes with the end in mind, filling in gaps and, streamlining the approach to developing your product.
Tech Transfer
Tech transfer occurs as the drug progresses from lab to manufacturing. Changes in scale and materials can result in variability and process parameters may need to be modified to ensure product quality. We will work with the clinical or commercial manufacturing facility to successfully scale up the production and ensure a robust process.
Process Characterization
As part of the tech transfer process, we will help you to develop lab-scale models to ensure product quality at manufacturing scale. Scale down studies will assess aspects such as compatibility with materials used in production, filtration and sensitivity to shear.
Process Risk Assessments
The risk assessment process involves a series of steps to develop a deeper understanding of the manufacturing process. The goal is to decrease the risks associated with product quality and patient safety. The result of a risk assessment may be to reduce or increased the monitoring of some of the activities associated with the process to mitigate risk.
Process Validation
Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce the drug product meeting its predetermined specifications and quality attributes. We will help you develop your validation strategy in preparation for commercial manufacturing.