Cirrus Pharmaceuticals, Inc. - Process Development

Services

Overview

Formulation Development

Analytical Services

Characterization

Extractables & Leachables Services

Particle Size Analysis

Peptides and Proteins

Nanotechnology

Stability Testing

Device Evaluation

Process Development

Scale-Up/Tech Transfer

Regulatory Submission

Manufacturing Oversight and Batch Release

Packaging Component Evaluation & Selection

Tox/Batch Manufacturing

PROCESS DEVELOPMENT

Our formulation scientists and process engineers collaborate to develop a manufacturing process that can be optimized for robustness and efficiency, then scaled-up through careful evaluation of manufacturing parameters. Elements of the process may include:

Blending/homogenization

Filtration

Filling

Container/closure selection

Terminal sterilization (heat, filtration)

Lyophilization

For MDIs, HFA-134a and HFA-227 are the industry standards and equipment is available in house to execute a variety of cold filling and one- or two-stage pressure filling techniques.

Blending equipment is available for blend process development of dry powder formulations.

Novel process development is also available. Some processes have been patented for clients, with the client being the sole owner of the patent.