Preparing complex solutions for commercialization
At Woodstock Sterile Solutions, our customers often come to us with just a molecule and an early formulation concept. That’s when our formulation expertise comes into play.
Scale-up of liquid formulations presents numerous challenges that require specialized expertise and experience. This is especially true for complex solutions, suspensions, and emulsions, as well as biologics, sterile products, potent compounds, and sensitive APIs.
To understand the interaction of APIs and delivery system materials, Woodstock Sterile Solutions conducts preliminary studies to determine a formulation’s sensitivities to temperature, pH, oxygen, and other factors. Understanding the formulation early in the development process, we can address those challenges to make a robust, scalable product for clinicals that translates well for commercial manufacturing.
The Woodstock Sterile Solutions formulations group brings decades of experience with liquid APIs, balancing the liquid formulation’s physical properties with the intended BFS delivery system to develop an optimized finished product.
Broad Registration, Accreditations and Certifications
- Registered for drug, combination device and food manufacturing with the U.S. Food and Drug Administration (FDA)
- State license for wholesale drug and food manufacturing and distribution
- cGMP Certifications through EU-competent authorities
- Manufacturing accreditations for Japan
- Potent material handling Safebridge 1-4
- ISO 13485:2016 Certification