Active Pharmaceutical Ingredient development : Contract Manufacturing



Download Alphora’s full line of services
(Adobe Acrobat Reader required)


OUR FOCUS:

Our Focus is on Success at Each Stage of Development

Alphora's Active Pharmaceutical Ingredient development efforts focus from the pre-clinical stage through to phase III and to the successful technology transfer to manufacturing locations throughout the world.

This focus of development includes:

  • Synthetic scale-up development
  • Analytical development and validation
  • Stability testing
  • Gram to kilogram synthesis, both cGMP and non-GMP
  • Technology transfer services

Our attention to detail, with our focus to the program's ultimate success, enhances value at each step in the development process.

OUR SERVICES:

Services for Ultimate Success

At whatever stage Alphora services are applied, it is with a view of the long term scale up and commercialization of the Active Pharmaceutical Ingredient. At all stages of development, Alphora will consider issues related to:

  • Routes and opportunities for early stage convergence
  • Identification of strategic intermediates as candidates for nonGMP outsourcing
  • Process optimization
  • Raw material costs and commercial sources
  • Related compounds and potential impurities
  • Final isolations and methods
  • Analytical method development and validation
  • Specification development
  • Stability of the final compound and intermediates

Home | About Us | Facilities | Capabilities | Services | Events | Contact Us
Career Opportunities | Management Team | Map | Sitemap