Successful Tech Transfer Plans Ensured On-Time Launches for Two Sponsors

Successful Tech Transfer Plans Ensured On-Time Launches for Two Sponsors

By Koshy George, Dylan Amig and Sundeep Sethia

Softgel Oraldose

The tech transfer planning process should begin with a review of the dosage form’s Critical Quality Attributes (CQAs), equipment train used, excipient functionality, and process. Pii staff consider whether anything technically can be made better, question the drug sponsor’s intentions behind the process, and attempt to mold that process in the similar equipment train at Pii.

In one example, a drug sponsor contracted Pii to handle a tech transfer from a competing CDMO. This was a first-to-market chewable tablet for veterinary use that comes in four strengths. These tablets have a unique shape and high tablet weight, especially for the highest strength. In test production, it was discovered that the highest strength tablet would break and chip during downstream processing. The high weight of the tablets resulted in plastic deformity and relaxation post compression, and the unique shape exacerbated the chipping issue.

In order to meet the sponsor’s launch goals, Pii formulation and MSAT teams proposed a short- and long-term solution. In the short term, instead of one common blend for the four strengths, Pii modified the blend for the higher strength within the SUPAC guidance to reduce the tablet weight and minimize the handling issues. For the long-term solution, Pii recommended round tablets to completely remove the chipping and breaking issues. The launch was on time and successful.

In another example, Pii handled the tech transfer of a liquid formulation for an Orphan New Drug Application (NDA). The liquid formulation drug was already developed at lab scale. After due diligence and creating a framework and tech transfer plan, commercial-scale production was set in motion with a specific equipment train.

During the engineering batch, particles were observed in the solution towards the later part of the filing process. The particles came from the gaskets of the displacement filling pump. The formulation developed was a simple solution of API in mostly water without any other excipients that could lower the friction between the gasket and the walls. This resulted in gasket wear out after a certain period of filling.

Options to change to different filling pumps were available, but involved long lead time and cost. Maintaining the launch time was critical for this product. The formulation and MSAT teams determined the exact failure point of the gasket and decided that the filling be validated with a specific number of bottles whereupon the gasket would be replaced to mitigate the issue. The sponsor was able to launch the product on time.

Talk to a Pii Scientist


Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) located in Hunt Valley, Maryland. The experienced scientists, engineers, and staff at Pii pride themselves on adroitly employing a phase appropriate method of drug development for the prudent use of their customer’s resources as they solve challenging problems. In addition to offering end-to-end development services, Pii manufactures a variety of dosage forms to include complex parenteral drugs and has a wealth of analytical testing capabilities. Its Hunt Valley campus has four aseptic suites with lyophilization capabilities. Our talented professionals stand ready to help!

Koshy George

Koshy George
Associate Director of the Manufacturing, Science and Technology

Koshy George is Associate Director of the Manufacturing, Science and Technology at Pii. He began working for Pii in 2003, setting up the Validation/Qualifications and Technology Transfer department as a group leader within the Formulation Development and Operations Departments. Mr. George has successfully performed numerous product tech transfers (site change, pilot-scale development, commercial scale), validated, and launched multiple New Drug Applications (orphan drugs, hormones, potent, DEA-schedule drugs, veterinary chewable tablets, tablet in tablet and soft gels) and Generic Abbreviated New Drug Applications (tablet, hardgel capsule, soft gel capsules, nanosuspension, solution, lotions, creams, and ointments) throughout his tenure at Pii.

Mr. George has more than 25 years of experience in Oral Dosage Formulation Development, Quality Compliance/Assurance, Manufacturing Science & Technology, Product Life Cycle Management, Process and cleaning validation, CSV, Calibrations, Tech Transfer, and Packaging with DSCSA emphasis. He has dual Graduate degrees: a Master of Science in Pharmaceutical Sciences and a Master of Science in Biotechnology from the University of Maryland, Baltimore County. He holds certifications from the National Institute of Health (NIH) in Clinical Pharmacology and in Clinical Research and is affiliated with the International Society for Pharmaceutical Engineering and American Association of Pharmaceutical Scientists, through memberships and mentorship programs.

Dylan Amig

Dylan Amig
Head of Manufacturing and Packaging

Dylan Amig is the Head of Manufacturing and Packaging for orals, solids, and non-sterile liquids. Dylan’s leadership has grown in increasing responsibility where he leads and supports strong Manufacturing Science & Technology (MS&T), Manufacturing, and Primary/Secondary Packaging teams. Dylan practically grew up at Pii, starting as a Manufacturing Technician for solid dose production in 1999 while still in high school. Mentored by Pii’s founder and former CEO, Dr. Syed Abidi, Dylan went on to hold a variety of positions at Pii, including Production Supervisor; Senior Supervisor, Manufacturing; and Senior Manager, Manufacturing. Throughout those years, Dylan cemented himself as an integral part of Pii’s growth, successfully working on programs from early stages of development and seeing them through to commercialization – having been an integral part of commercializing over 30 programs.

Sundeep Sethia PhD Senior Director R&D

Sundeep Sethia, Ph.D.
Head of R&D

Sundeep Sethia joined Pii in September 2018 as Senior Director of Pharmaceutical R&D. He has over 15 years of experience in the pharmaceutical industry.

Dr. Sethia formerly served as the Director of Pharmaceutical R&D at Amneal Pharmaceuticals. Prior to Amneal, he held positions of increasing responsibility at both Teva and Barr Laboratories in R&D. His expertise is in drug development across a broad range of therapeutic areas and dosage forms. He has a proven track record in generic drug development and approvals.

Dr. Sethia received his Ph.D. in Pharmaceutical Sciences from St. John’s University, NY. He earned a Master’s and a Bachelor’s degree in Biotechnology and Pharmacy, respectively from Jadavpur University in India. He has co-authored various peer-reviewed scientific publications and patents/patent applications.

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