Journal of Developing Drugs
Open Access

Challenges in analytical method development of biopharmaceuticals

4^th International Summit on GMP, GCP & Quality Control

October 26-28, 2015 Hyderabad, India

Kalyana Sundaram R

Lupin Limited (Biotech Division), India

Posters-Accepted Abstracts: J Develop Drugs

Abstract :

Biopharmaceuticals are the diverse groups of bio-therapeutics that offer supportive therapy to many critical conditions like cancer, auto-immune diseases, etc. Many of these biopharmaceuticals are macromolecules like proteins. Analytical methods developed for characterization of the proteins include HPLC based methods, Capillary Electrophoresis methods, Electrophoretic methods, ELISAs and Real time PCR methods. Lot many challenges are encountered during development of the analytical methods for biopharmaceuticals. Some of them are: Lack of availability of reference standards and impurity standards, extremely low levels of impurities in the test samples, sensitivity of analytical methods, lack of clear guidelines on acceptable assay variation, etc. Many of these challenges can be overcome by adapting several sample preparation techniques, sample enrichment techniques, improvement of assay range, etc. A robust analytical method requires validation as per ICH guidelines. Parameters included in analytical method validations are based on the category of the test. The most important parameters are specificity, linearity and range, precision, accuracy, limit of detection and quantitation.

Biography :

Email: kalyanasundram@lupin.com