Manufacturing best practices are critically important to your product’s transition from drug substance to human-ready clinical material. Dr. Gerhard Reuter, a quality expert authorized by the EU, explains which cGMPs are most important for your clinical batch.
Key insights in this video
Dr. Gerhard Reuter, Qualified Person
Dr. Reuter is a veteran quality specialist who plays a critical role in managing the integrity medication manufacturing systems and authorizing the release of product batches. In his role, he works closely with pharma and biotech to help them develop cGMP-compliant aseptic manufacturing processes.
Why cGMPs matter to your clinical trial material
Manufacturing best practices are critically important to clinical, operational, and financial success of your development program. In just the past five years, the FDA has issued more than 600 manufacturing citations. That’s more than 600 setbacks, 600 delays, 600 additional costs that have held back programs like yours. Current good manufacturing practices – cGMPs – are something to take seriously as soon as your product leaves the laboratory.
In this video, Dr. Reuter explains what you need to know about cGMPs for your injectable drug product, how and where to start planning a cGMP-compliant clinical batch, and why you need to take the time to get these early process steps right. As Dr. Reuter notes, factoring these guidelines in early can help you save significant amounts of time and capital downstream.
So what are cGMPs? They’re a continually evolving set of standards and regulations that help ensure the quality and safety standards of a product that will be used in humans. For an injectable medication, those regulations are particularly complex and stringent; the shift from preclinical to clinical development comes with a range of new procedural, logistic, and regulatory considerations. Since these guidelines are always evolving with the science, technologies, and products they pertain to, it’s important to have an expert partner like Vetter to help you understand, navigate, and compy with all relevant cGMPs for your molecule.
3 key components of a cGMP-compliant clinical batch
As quality expert Dr. Gerhard Reuter explains, teams developing a parenteral medication ultimately need to integrate a comprehensive quality system into their manufacturing processes. That system should include three essential steps:
1. Qualification: Matching your molecule with the right manufacturing equipment (eg, filling machines, sterilization equipment, containers, tubing) as well as professional experts with the right training and technical, operational, and scientific skills to handle your product.
2. Validation: Developing the right manufacturing process for your molecule. This includes not just filling methods, but also filter validation, media runs, and testing methods optimized for your molecule.
3. Documentation: Recording every step to regulatory standards. Any and all decisions and changes need to be documented, from start to finish. Regulators will want to see the thought behind your processes.
Creating this kind of system can be a daunting process for drug development teams, but a CDMO like Vetter can help you navigate this process and set you up for success with each of these three components. When you’re ready to fill your clinical batch, you may be focused on getting your product into the clinic as quickly as possible – but it’s vitally important to take your time, look at the cGMPs, and ensure you are compliant with these critical regulations.
As Dr. Reuter says, “If I can give you one piece of advice, don’t rush good manufacturing practices. Take the time to get this part right. It will save you a lot of time and a lot of money.”