SCIEX, Beckman Coulter Life Sciences and Express Pharma, organised a seminar on ‘Importance of impurities profiling and formulation stability studies in regulated pharma environment’
Sanjiv Das – Visakhapatnam
Worldover, regulatory agencies have put in place guidelines which mandate the identification and profiling of impurities in APIs and formulated drug products. This indicates that henceforth there will be critical attention given to impurities profiling from regulatory authorities even in India. Therefore, the role of impurities profiling takes a new significance within the pharma industry.
Keeping this in mind, SCIEX in association with Beckman Coulter Life Sciences recently hosted a seminar on ‘Importance of impurities profiling and formulation stability studies in regulated pharma environment’ in Visakhapatnam. Organised by Express Pharma, the seminar witnessed participation from sixty delegates, which included plant heads, quality control officers, quality assurance managers, project heads and scientific officers from various pharma companies.
Dr. Niraj Khurana, Head Marketing and Applications, Beckman Coulter Life Sciences
The seminar began with a welcome address by Express Pharma correspondent, followed by a presentation by Dr. Niraj Khurana, Head Marketing and Applications, Beckman Coulter Life Sciences. Khurana gave a brief description about Danaher Corporation and about the company’s role in the fast growing Indian market. He also talked about Danaher family of brands.
This was followed by Ferran Sanchez, EMEAI Market Development Manager, SCIEX, who gave an insight about ‘360 degrees biopharmaceutical characterisation.’ He gave an idea about trends in bio pharmaceuticals, characteristics, main workflows etc., and also mentioned about opening up of SCIEX University. He emphasised on training among pharma experts, which is very important for ones growth and mentioned that the pharma industry is shifting towards development of larger molecules targeting various diseases more specifically.
Ramanuj Samal, Application Specialist, Beckman Coulter Life Sciences was the next speaker. He talked about particle characterisation and stability study of formulation. During his session, he gave inputs on various products, which have been recently launched and their functionalities. He also provided a detailed insight on centrifugation, flowcytometry and liquid handling system and their application in pharma and biopharma industry and mentioned about drug dissolution study using Coulter principle.
Raghunath MV, India Market Development Manager, SCIEX, provided insights on impurity profiling solutions in large and small molecule application. He talked about goals of impurity profiling, major type of mass spectrometer and various type of mass spectrometry instruments etc.
Further on, Samal talked about ‘PAT 700 TOC: Reduce the risk of product recall at reduced cost of ownership’. He elaborated on how to measure TOC and conductivity, the definition of organic carbon and its importance, the use of conductivity and its importance, process analytical technology etc.
This was followed by a Q&A session, which was enthusiastically taken part by the participants.
The concluding remarks was given by Khurana, who thanked the audience for attending the seminar and making it into an eventful one. The evening ended with cocktail and dinner, where the audience networked with each other.