Active Pharmaceutical Ingredients

A SINGLE TEAM

To ensure clinical and commercial success, Alphora's synthetic organic and analytical chemists operate as a single team on each project.

SYNTHETIC ORGANIC DEVELOPMENT

Creative Solutions
Alphora's scientists specialize in creative synthetic organic chemistry and possess international experience in both industrial and academic environments.

Experience and Expertise
This experience includes the process development of hundreds of pre-clinical and clinical Active Pharmaceutical Ingredients and their commercialization. The depth of this experience is further enhanced by a background in medicinal chemistry, to provide a broad range of techniques and approaches. Alphora also has considerable experience with issues relating to intellectual property and its value enhancement.

The Depth to Find the Answers
With an extensive industrial history and a solid academic background, Alphora has a broad range of organic chemistry capabilities, along with a knowledge of the latest techniques and technologies.

This capability has been demonstrated on a number of complex projects, including natural product syntheses, involving a large number of steps and one or more chiral centers, with considerable success for its clients.

A STRONG ANALYTICAL FOCUS

Analytical and Specification Development
Alphora works with its clients to develop a specification that ensures the quality of the Active Pharmaceutical Ingredients throughout the development program. This effort includes: method development and validation; the synthesis and characterization of impurities and metabolites; characterization of crystal forms; and, the development of in-process testing capabilities to successfully track the process through its synthesis.

Stability Studies
To support the development efforts, Alphora also provides Active Pharmaceutical Ingredients stability services, with chambers at room temperature, intermediate and accelerated conditions. ICH compliant photostability conditions are also available.

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