1. We are pleased to feature you in Vol 7 of BioZesta, How was your experience as a guest lecturer at Biocon Academy?

• I am very satisfied with my interaction with the students at Biocon Academy. I am overwhelmed to see the students are keen to know the nuances of the Biotech industry. It was a great pleasure to see the enthusiasm of the students. I had a walk down the memory lane and shared my two decades of work experience in the industry.

2. Your expertise in manufacturing and operations in Biocon is profound. How do you think working in these domains has shaped your career over last 23 years?

• Working in the domain for past 23 years has given me immense process knowledge that has helped me leverage my API skills. My experience in these domains have also helped me in treating the biologics space as a generic space and establish cost leadership.

3. What are your thoughts on Biocon Academy’s programs? How beneficial are these programs for biotech students?

• Biocon Academy has a very unique concept of learning along with practical hands- on- training which makes the program very helpful and engaging for the students. It makes students industry oriented and gives them a holistic understanding of the subject. Transforming the academic knowledge into industrial skills for the development of technology and regulations.

4. How are the operations of Malaysian Insulin manufacturing plant different from that of India’s manufacturing plant?

• Malaysia Insulin is fully automated plant while India is a more a manual plant. The scale is also almost 2.
• Biocon’s rh-insulin, facility at Johor, is Malaysia’s first locally made Biosimilar Insulin facility to be approved by the National Pharmaceutical Regulatory Authority (NPRA) for commercial sales in the country. Biocon has also launched its Biosimilar Insulin Glargine brand, Basalog®, in Malaysia.

5. Biocon’s Insulin manufacturing facility in Malaysia is the largest in Asia. Are there any challenges that you face during regulatory audits? How do you overcome them?

• Biocon Biologics takes cGMP and Data Integrity very seriously. We face   challenges like documentation process, adherence to procedure etc.
• We have been able to overcome these challenges by bringing in talented fresh graduates from universities and train them effectively from the very beginning of their career. We have a set up strict and compulsory training program for educating and addressing these issues. Besides, we regularly  engage with the employees to foster a culture of quality in our Malaysia facility.

6. As Biocon takes a leap with its new entity, Biocon Biologics. How will you comprehend the paradigm shift in the business vertical of biologics?

• It will call for new orientation & skill sets to operate in the global arena.

7. How do you think Biocon Biologics is making a difference among its Patients, People, Partner & Business in global health?

• Affordability and innovation are enabling us to reach patients across the globe.  The recent announcement by Kiran Mazumdar Shaw at UNAIDS Health Innovation Exchange side meeting, to reduce the prices of rh-insulin at less than 10 US cents to enable affordable access to life-saving therapy for patient in low and middle-income countries which is an example of bringing affordability and accessibility of diabetes care in undeveloped & developing countries.

8. Can you brief us about the large scale complex engineering of drug substance used in the entire production of Insulin?

• The purification of reverse phase chromatography is the most complex and challenging. We operate at 70bar pressure in this particular phase.

9. What changes have you seen in your years of experience in the production of Insulin, then & now?

• The level of compliance has gone up and the use of automation and giving confidence to the auditors have become pivotal. The importance of operational excellence and power of data analytics have become pivotal to establish cost leadership and process understanding.

10. How do you achieve economies of scale for mass production?

• Economies of scale depend on the level of understanding ‘know-how’ and ‘know-why’. Based on this understanding and engineering principles, we can achieve economies of scale.

11. What is the kind of talent you believe Biocon’s Manufacturing & Operations team looks for?

• Sound subject knowledge, good documentation and communication skills are the basic pre-requisites for a rewarding career at Biocon Biologics, Malaysia.

12. One advice for the students seeking career in Production & Manufacturing?

• Learn the basics very well. Your aptitude and attitude will determine your altitude of life.

Profile:

Mr Sethumadhavan Sankaran delivers guest lectures at Biocon Academy on a regular basis. He has 23 year of experience in the field of manufacturing and operations. Currently, he is a Vice President of Insulin Production in Biocon Malaysia. He has been heading operations and manufacturing of Insulin and Analogs at Biocon for over 5 years.