What Is The Benefit Of Doing An Engineering Batch In The Pharmaceutical Industry?

By Mike Fan, Engineering Manager, Bora Pharmaceuticals

So, your new product is ready for the next step – commercial manufacturing production. You have decided not to invest in new equipment or building a new manufacturing line. You’re now looking to partner up with a contract manufacturing organization (CMO) for your commercial needs. What should you expect from your CMO/CDMO partner? Better quality, fewer product failures, and stronger expertise are some skills that probably come up immediately in your mind.

Working with your CMO partner to invest in new equipment or build a whole new line for Oral Solid Dosage (OSD), semi-solid, or liquid manufacturing and packaging, you will need to collaborate with your contract manufacturing partner to target solutions to achieve outstanding results. Before producing that first batch, the equipment or the whole line needs to be qualified under cGMP requirements and that includes purchasing, construction, installation qualification, operational qualification, performance qualification, and process performance qualification (IQ/OQ/PQ/PPQ). These all require engineering expertise which a good contract manufacturing partner will provide because they have a strong background in manufacturing and quality systems.