DEVELOPMENT SERVICES

The scientific staff at Stella Hill Laboratories, Inc. has more than 30 years of experience across all areas of parenteral formulation and manufacturing. From pre-clinical through clinical and on to commercial manufacturing, Stella Hill focuses on optimizing your product’s stability and performance. With our in-depth expertise, we can assist your development efforts in the following areas:

• Liquid formulations
• Lyophilized formulations
• Suspension and dispersed-system dosage forms
• Manufacturing process design and optimization of existing processes
• Manufacturing scale-up and technology transfer

Whether your product is a small molecule or a biotech pharmaceutical (protein, peptide or oligonucleotide), Stella Hill can assist you in the design and execution of pre-formulation and formulation development studies that will help define your final drug product formulation. Of course, the results of the formulation development work must be integrated with primary packaging selection and process design phases to yield a parenteral product that meets or exceeds your performance expectations for clinical drug product, and ultimately, for a marketable product.

If you choose to lyophilize your drug product, Stella Hill has the experience and tools necessary to help design a stable dosage form along with an effective and efficient lyophilization cycle. Stella Hill scientists have an extensive knowledge of successful formulation strategies for stabilizing sensitive protein and peptide pharmaceuticals. Our differential scanning calorimeter and lab scale lyophilizers allow us to establish optimum lyophilization cycle parameters for your drug product.

Stella Hill’s well known and highly respected analytical testing laboratory will be an indispensable part of the development effort. Existing methods can be tech-transferred into the laboratory or the experienced Stella Hill analytical scientists can assist in the development of stability-indicating analytical methods for use in development studies as well as finished drug product release and stability studies. The laboratory has stability incubators covering the full array of ICH temperature and humidity conditions to support these activities. These incubators are connected to a back-up power supply and are continuously monitored by a SCADA system that will contact maintenance personnel if operational problems arise.