The following books, in which our researchers participated in writing, have been published.。
Book: Procedures for Implementing Technology Transfer (Test Method, Manufacturing Process) and Ensuring Equivalence – Case Studies of Management of Contract Manufacturers (Domestic/Overseas) by Each Stage
Publication date: September 27, 2019
Author: Part 2, Chapter 4 “Successful Technology Transfer of API Manufacturing in the Early Stage of Development – API Process Development from the Drug Discovery Stage
Author：Mitsuhisa Yamano（Associate Director , Chemical R&D Division)
In recent years, the emphasis on speed in new drug development has not given adequate time for the development of API manufacturing methods. Therefore, there is a need to implement technology transfer with scale-up manufacturing within a tight limited time frame. In this book, our researchers explain the necessary know-how to avoid manufacturing troubles in the case of technology transfer with examples.
This book is a collection of the experiences and wisdom of companies in the field of “technology transfer”, and contains commentary on early development, APIs, formulations, and biopharmaceuticals from professional and technical points of view that only experts in the field can provide. In addition, the section on outsourcing cases includes many considerations about competitive.
SPERA PHARMA is committed to contributing to the rapid creation of pharmaceutical products by solving the challenges faced by our customers through further refinement based on our cultivated technology and experience.