The impurity profile is a crucial factor for the quality of drugs and processes.
Deficiencies on impurity profiles are among the top ten reasons for revenue losses through delayed product launch, decreased shelf life, etc.
Delayed product release – loss of sales
No routine process – high failure rates
Neglected impurity profile – high development costs
Short product shelf life – competitive disadvantage
RD&C developed a novel systemic analysis concept for impurity profiling and impurity related deviation management in pharmaceutical drug process development and routine manufacturing. Impurity issues are a major challenge for the pharmaceutical industry. An integral, systemic view on the entire production process necessary for sustainable impurity evaluation is generally missing and often relevant in-house expertise is lacking. RD&C offers impurity profiling and optimization in early preclinical development within chemistry, manufacturing and control according to ICH, EMA and FDA guidelines to foster applications and drug approval process.
Additionally, RD&C provides support on impurity related deviation management for routine drug manufacturing involving identification, analysis, synthesis, and qualification of unexpectedly appearing impurities and degradation products. Moreover, RD&C’s vision is to generate a database consisting of qualified impurity reference standards including Certificate of Analysis, analytic and synthetic methods and a toxicological assessment.
