The entries of “Technologies made in Vienna” are displayed in the project language.
Technologies from Vienna
RD&C Research, Development & Consulting GmbH
Systemic analysis concept for impurity profiling and impurity related deviation management in pharmaceutical drug process development and routine manufacturing.The company focuses on the development of impurity reference standards for the use in development, qualification and registration of drugs for human use. The main objective of RD&C is to develop theoretical concepts assessing synthesis pathways and finishing off pharmaceutical products for the prediction and probability of the emergence of impurities. Moreover, the company will provide strategies and recommendations for avoiding, analysing and monitoring of different types of impurities. These services will be backed by impurity reference standards, synthesized and qualified by RD&C and partners. The impurity reference standards will be available in milligram to gram scale including Certificates of Analysis thus meeting regulatory requirements for impurity qualification. Upon request these impurities are also toxicologically and pharmacologically characterized by in silico and in vitro methods.
Development of an impurity reference standard conceptRD&C aims to provide support and scientific advice for impurity issues in pharmaceutical drug substances and products. Impurities have to be identified, qualified and documented in the course of the drug approval process for the drug substance and the drug product. This is sometimes a major challenge for companies, since they often lack relevant in-house expertise and a holistic view on impurity issues. RD&C will offer solutions for the companies in a customized one-stop-shop manner with individual services and modules. They may include theoretical concepts for impurity handling and avoidance, the delivery of impurity reference standards including a Certificate of Analysis, and a toxicological expert report on the toxicology profile. Since RD&C is not able to cover all aspects of the broad service portfolio a consortium of partners has to be established and strengthened to provide a sound basis for a sustainable, good collaboration and economic success.
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