Biopharmacuetical Process-related Impurities Analysis

International Conference on Harmonisation (ICH) Q6B provides guidance on the general principles for justifying the specifications of products- and process-related impurities. The intent is to ensure the quality, safety, and efficacy of these drugs when delivered to patients. Process impurities are related to the manufacturing process, and are those derived from the manufacturing process such as:

Process-related impurities in biopharmaceuticals are potentially toxic and may cause adverse reactions in animals and humans. Therefore, these impurities must be determined to ensure that their content are within acceptable levels. The implementation of an effective characterization for these impurities is very important for the development of biopharmaceuticals.

Process-related impurities typically exist in trace amounts, and the determination of them can be challenging. When you face some challenges, Alfa Chemistry offers comprehensive solutions for you. Alfa Chemistry is a world-leading provider of impurity testing in biopharmaceuticals with extensive method development experience. In addition, our analytical lab is equipped with a wide range of state-of-the-art instruments. We can develop highly specific and sensitive methods suitable to your specific sample following the ICH Q6B Guidelines. If you have any doubt about biopharmaceutical process-related impurities analysis, please feel free to contact us.

Alfa Chemistry's capabilities include but not limited to:

Alfa Chemistry's advantages:

References

• Bracewell DG, Smales CM. (2013) 'The challenges of product- and process-related impurities to an evolving biopharmaceutical industry.' Bioanalysis. 5(2):123-6.

• Raghani, Anil & Li, Kim & L. Bussiere, Jeanine & P. Bercu, Joel & Qiu, Jinshu. (2017). 'Process-Related Impurities in Biopharmaceuticals: An Implementation Guide.' ICH Quality Guidelines. pp. 487-507.