Broad experience, expertise, & capabilities

Our world-class sterile injectables capabilities include formulation and process development and manufacturing of sterile injectable drug products at scales suitable for small clinical trials to large global commercial supply. With Thermo Fisher Scientific as your single-source partner, you’ll be able to bring your discoveries to market with more speed and efficiency than ever before.

Partner with Patheon, part of Thermo Fisher Scientific to access extensive sterile injectable pharmaceutical manufacturing capabilities at all scales, including liquid-filled and lyophilized vials and pre-filled syringes and cartridges.

We will bring speed, flexibility, experience and a broad set of capabilities to your program. In the early clinical phases, these are critical to establishing a robust, scalable process. Our experts have the experience and capabilities to develop an optimal formulation and process with long-term commercial manufacturing in sight. Offerings include:

  • Formulation development
  • Lyo-cycle process development and optimization
  • Manufacturing process development
  • Mixing and pump-shearing studies
  • Holding time studies
  • Freeze-thaw studies
  • Cleaning validation
  • Product contact part compatibility studies
  • Sterilization cycle development and validation
  • Scalability studies

 

Process Transfer

We also specialize in technology transfer for steriles projects. Learn more about our Tech Transfer expertise and experience.


Process Validation for Steriles

We also offer complete process validation in accordance with regulatory and cGMP guidelines – an essential step in the establishment of a reliable high-quality commercial supply. This includes:

  • Quality by Design (QbD) and Proven Acceptable Ranges (PAR)
  • Validation of analytical assays
  • Release testing
  • ICH stability studies
  • Container shipment studies
  • CMC documentation in CTD format
  • Continuous Process Validation