With the complexities involved in the safe handling of potent molecules and increasing regulatory requirements, it is imperative to choose the right partner for the successful HPAPI development, manufacturing, packaging, and ultimate commercialization.
Identifying a partner with the relevant capabilities, expertise, and experience to collaborate through this journey is a critical decision point for any company looking to outsource.
Watch our speakers discuss the critical factors that should be considered when choosing the right CDMO for end-to-end HPAPI Development services.
Starting with the first and most critical step of accurate potent classification and the importance of OEL assessment, through to the adoption of a risk management approach through SMEPAC testing as the product moves through the various stages of processing from dispensing, through granulation to final dosage.
Topics covered also include the best practice of using fully-contained engineering solutions and applying the latest in regulatory guidance. Following the development and manufacturing processes, as well as the key considerations for both primary and secondary packaging. During the packaging discussion, specific aspects of packaging highly potent products including, heightened air filtration systems, ISO8 standards, room pressure differentiation and the general principles of containment controls to ensure operator safety were covered.
If you are in the process of assessing your outsourcing options for the development, manufacturing and packaging of highly potent products or simply wish to know more about the processing of such specialist products, this webinar is designed to combine theory with practice, drawing on the experience built up over 35 years of working in this specialist space.