The course was targeted for professionals from the pharmaceutical, diagnostic, biotechnology and vaccine industries in India and designed to provide in-depth knowledge of theoretical and practical aspects of lyophilization in formulation/process development of lyophilized pharmaceutical products.

The contents of the course were planned with input from BCP colleagues by Dr. Madhav Kamat – Founder/CEO of Kamat Pharmatech LLC, a pharmaceutical consultancy/development firm in New Jersey, USA. Dr. Kamat is an alumnus of Bombay College of Pharmacy (B. Pharm. – 1979). He completed his M. Pharm. from Grant Medical College, Mumbai in 1983, and Ph.D. from the College of Pharmacy at University of Kentucky, USA. His Ph.D. dissertation was also based on lyophilization technology. Dr Kamat is an industry professional with more than 35 years of experience in sterile product/processes development, lyophilization, scale-up/technology transfer, nanosuspensions and manufacturing with experience of more than 20 commercialized lyophilized products in the US.

The training course was targeted especially for industry delegates and twenty senior professionals from companies such as Pfizer Products India Pvt Ltd, Mumbai; Natco Pharma Ltd, Hyderabad; Lyophilization Systems India Pvt Ltd, Telangana; Zydus Life Sciences, Ahmedabad; Zydus Hospira Oncology Pvt Ltd, Ahmedabad; Ciron Drugs and Pharmaceuticals Ltd, Navi Mumbai; Serum Institute of India Pvt Ltd, Pune; Hester Biosciences Ltd, Ahmedabad; Sovereign Pharma Pvt Ltd, Daman and Diu; Sovevax, Biologics Pvt Ltd, Daman and Diu; Tofflon India Pvt Ltd., Mumbai; and Apothecon Pharmaceuticals Pvt Ltd, Vadodara, participated in the training course. The part of this training program was financially supported by Lyophilization Systems India, Telangana – a leading lyophilizer equipment manufacturer in India.

The course detailed topics such as stages of the lyophilization process, pre-formulation and formulation development, container and closure systems, characterization of freeze-dried products, process development and cycle design, QbD and Risk Assessment (RA) concepts, and equipment, validation and regulatory aspects.

During the span of two days, Dr Kamat gave a detailed account of the technical aspects of lyophilization in a very simplified manner in eleven lectures that included almost 490 slides. The sessions were received enthusiastically by the attendees and had several interactions and discussed many problems experienced by them in relation to the lyophilization process at their respective labs/companies/individual practices.

The course was concluded with a valedictory function presided by Mr. Maniar, the Chairman of Bombay College of Pharmacy and by Dr Krishna Iyer, the Principal of Bombay College of Pharmacy. The vote of thanks was delivered by Dr. Mala Menon, Adjunct Professor.

Following M. Pharm students volunteered during the entire two day course taking care of the attendees and ensuring smooth logistics of the event: Ms. Rashmi Singh, Ms. Nisha Sharma, Mr. Prajay Gugliya, Ms. Bhakti Kubal, and Mr Harshad Wagh.

BCP plans to organize more of such courses with Dr. Kamat and other expert professionals in various fields in the coming years.

From the report prepared by Ms. Rashmi Singh, S.Y. M.Pharm student, Bombay College of Pharmacy.