Indian Pharmaceutical Association – Maharashtra State Branch’s (IPA-MSB’s) Bombay College of Pharmacy (BCP) organized a two-day comprehensive training course on “Lyophilization Technology: The Theory and Practice of Freeze Drying of Pharmaceuticals” on 27th and 28th May 2024 at BCP. The course was designed for professionals from India’s Pharmaceutical, Diagnostic, Biotechnology, and Vaccine industries and aimed to provide in-depth knowledge of the theoretical and practical aspects of lyophilization in formulation and process development of lyophilized pharmaceutical products.

The course content was developed by Dr. Madhav Kamat, founder/CEO of Kamat Pharmatech LLC, a pharmaceutical consultancy/development firm in New Jersey, USA. Dr. Kamat graduated from BCP (B.Pharm 1979), earned an M.Pharm from Grant Medical College, Mumbai, in 1983, and obtained a Ph.D. from the College of Pharmacy at the University of Kentucky, USA. His Ph.D. dissertation focused on Lyophilization Technology. Dr. Kamat has over 40 years of experience in sterile product/process development, lyophilization, scale-up/technology transfer, nanosuspensions, and manufacturing. He has commercialized over 24 lyophilized products in the US.

The training was attended by twenty-four delegates from various companies across Indian Pharmaceutical Industries namely Pfizer Products India Pvt Ltd, Mumbai; Schott Poonawalla Pvt. Ltd., Mumbai; NATCO Pharma Ltd, Hyderabad; Serum Institute of India Pvt Ltd, Pune; Tofflon India Pvt Ltd., Mumbai; Rubicon Research Pvt. Ltd., Mumbai; Syngene International Limited, Bangalore; Hetero Labs Limited, Hyderabad; Panacea Biotec Ltd., New Delhi and ImageProVision Technology Pvt. Ltd., Pune.

The training program was sponsored by

• Schott Poonawalla Pvt. Ltd, one of India’s leading primary packaging provider for the pharma and biotech industries,

• Tofflon India Pvt Ltd., Mumbai, a comprehensive pharmaceutical equipment supplier, offers process support, core equipment, integrated systems, and pharma engineering for pharma as well as biotech industries,

• ImageProVision Technology Pvt. Ltd., Pune, specializes in processing and detailed analysis of images, along with developing image processing applications.

The workshop commenced on 27th May 2024 with a welcome speech by Dr. (Mrs.) Ujwala Shinde, HOD, Pharmaceutics Department, BCP, followed by an introduction to the course by Dr. Kamat and an introduction of the participants.

Twelve lectures in two days course, approximately five hundred slides, Dr. Kamat presented a comprehensive and straightforward exposition on the technical aspects of lyophilization, accompanied by pertinent observations and recommendations from his extensive 40 years of experience. Topics including physical properties and characterization of materials, fundamentals of freezing and various stages involved in freeze drying, container-closure systems, formulation development of small and large molecules, development of the lyophilization process, quality control tests and validation along with scale-up and transfers, were covered in detail in the course. Other specific topics discussed were non-aqueous lyophilization, syringe freeze-drying, remote sensing of product temperatures, and bulk freeze-drying.

Experts delivered additional talks from the Sponsors’ teams, which included:

a) Container-closure systems by Mr. Ajith Kumar, Director of Operations, Schott Poonawalla Pvt. Ltd. He touched upon topics like properties of materials used, processes used to manufacture, types, geometry, and compatibility of container-closure systems. The Schott team also had an exhibit table showcasing several container-closure systems, syringes, cartridges, vials, ampoules, and other products.

b) Mr. Sandeep Kulkarni, CEO and Founder of Image ProVision Technology Pvt. Ltd., Pune, along with Mr. Anil Pandey, General Manager (Global Application Support) gave a brief overview on Microscopic Particle Analysis assisted by Artificial Intelligence/Machine Learning and Hot-Stage Microscopy.

The attendees heartily embraced all the sessions on both days, which featured many exchanges and discussions on numerous issues regarding the lyophilization process that they had encountered at their practices, companies, or labs.

Participants got a detailed course booklet and meaningful souvenirs courtesy of BCP, enhancing their overall experience.

The course was concluded with a valedictory function wherein all the participants were given certificates, and volunteers were felicitated. This was followed by the felicitation of Dr. Kamat by the Principal and Professor of Pharmaceutical Chemistry, Dr. Krishna Iyer. Further, Dr. Mala Menon, Adjunct professor, gave a vote of thanks.

During the entire course, M. Pharm students, including Ms. Kasturi Pawar, Ms. Anupama Patil, Ms. Dipti Solanki, Ms. Gauri Lokhande, Mr. Mayur Mahajan, Ms. Sakshi Bundake, Ms. Poonam Pusdekar, and Ms. Aishwarya Dabhade graciously volunteered to oversee attendee assistance and ensure the seamless coordination of event logistics.

The participants have enthusiastically provided overwhelming feedback regarding the comprehensiveness and relevance of the course content, as well as the professionalism and effectiveness of the course. Success and positive feedback have prompted BCP to plan and organize more such courses with Dr. Kamat and other expert professionals in various fields in the coming years.

Report from write up compiled by Ms Kasturi Pawar, M.Pharm student of BCP