Formulation

Preparing Complex Solutions for Commercialization

At Sustainable Innovations, our formulation development services guide our customers’ paths to market, often beginning with just a molecule and an early formulation concept.

Pharmaceutical 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, Sustainable Innovations conducts preliminary studies to determine a formulation’s sensitivities to temperature, pH, oxygen, and other factors. By understanding this information early in the complex sterile formulation development process, we can address those challenges to make a robust, scalable product for clinical supply that translates well for commercial manufacturing.

The Sustainable Innovations’ pharmaceutical formulation development service brings decades of experience with liquid APIs, balancing the liquid formulation’s physical properties with the intended BFS technology 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