Formulation Development Services

Formulation Services from SGS can rapidly and cost-effectively move your molecule from development to clinic without sacrificing quality.

Scalable and flexible, our formulation development services are supported by strong in-house expertise in analytical and microbiology method development and ICH real time/accelerated stability studies. With a state-of-the-art facility capable of handling potent compounds, we have all the necessary scientific expertise to handle your formulation needs.

From our laboratory in Lincolnshire, IL we offer liquid and lyophilized development services for small and large molecules as well as technology transfer to cGMP manufacturing. SGS can also customize a project to your requirements.

Our Formulation Services for large and small molecules include a comprehensive service portfolio:

Preformulation development programs:
- Characterizing physico-chemical properties
- Improving solubility, if necessary
- Developing stability indicating assays
Formulation development programs:
- Target product profiling
- Screening buffers, pH, surfactants and stabilizers (DOE)
- Evaluation of antioxidant and preservative compatibility
- Lyophilization cycle development and optimization
- Assessment of product shelf life via accelerated and real-time stability
- Container-closure compatibility and selection
- Pre-filled syringe compatibility and selection
- Technology transfer for manufacturing
- ANDA product development

Our Scientific Expertise Can Handle Your Formulation Needs

With a foundation built upon sound regulatory expertise, our scientists have a proven track record of bringing drugs from bench to market. They bring years of pharmaceutical industry experience in working with small molecules, large molecules and synthetic peptides. Each project is assigned a point-of-contact manager to shepherd your project to completion. We deliver work on time, within budget and according to plan.