Let's look at the basics of CTM manufacturing, the role of quality by design in CTM manufacturing and the benefits you can expect when you partner with UPM Pharmaceuticals for your CTM manufacturing needs.
What is Clinical Manufacturing?
Clinical trial manufacturing is a specialized form of pharmaceutical manufacturing focusing on creating drugs which will be used for clinical research. Working with clinical trial materials requires careful attention to detail to ensure safety and security.
What Is a CTM?
CTM, or clinical trial materials, are pharmaceuticals that are in a finished form suitable for administration to clinical trial participants but not intended for commercial sale.
Before manufacturing clinical trial materials, a plan and timeline must be created to help guide you through the development and clinical trial process. An experienced contract development and manufacturing organization (CDMO) like UPM Pharmaceuticals is able to provide valuable insight into a realistic timeline for developing and releasing a new drug.
Current Good Manufacturing Practice (cGMP) Guidelines
When manufacturing a drug of any kind, but especially in CTM manufacturing, FDA current Good Manufacturing Practice (cGMP) guidelines must be followed closely. Improper manufacturing practices of any kind can lead to contamination, which can be costly. Biologics can not be sterilized like small molecule drugs, so the whole process needs to be sterile and managed closely.
cGMP guidelines apply to most drugs that are in phase I and II development, especially vaccines, gene therapy, recombinant and non-recombinant therapeutic products and more.
The best ways to ensure you are following cGMP guidelines is:
- 1. Have a written quality control plan.
- 2. Maintain a controlled, sterile environment.
- 3. Record accurate and consistent data from the manufacturing process.
The Role of Quality by Design in CTM Manufacturing
The idea of Quality by Design (QbD) is credited to Dr. Joseph M. Juran. In his 1992 publication, he posited that most of the quality issues found in products were caused by a design shortcoming, so the quality of a product could be improved by improving the design from conception. Studies have shown that his theory has merit, as it is impossible to improve the quality of an improperly designed product by increasing testing.
When it comes to Quality by Design in clinical trials and CTM manufacturing, a high-quality product is one that provides its intended benefit while also being contaminant-free. To protect the general public and ensure that cGMP guidelines are maintained, the FDA strongly emphasizes the use of QbD principles by all drug manufacturers.
The fundamental principles of QbD in CTM manufacturing are:
- Determine the crucial characteristics of a product.
- Identify them as a critical quality attribute
- Employ process design to create a drug product that includes the critical material attributes and identifies the critical process parameters.
Benefits of Specialty CTM Manufacturing Services from UPM Pharmaceuticals
Using a CDMO like UPM Pharmaceuticals can help you successfully navigate the clinical trial process and get your drugs on the market soon. Our dedicated team brings years of experience and knowledge on subjects like formulations, cGMP guidelines, clinical trial data management, clinical trial supply management, packaging and more that can help your business easily move from clinical trial manufacturing to getting the product ready for market. We offer the clinical trial services you need to achieve success.
Contact us today and find out how UPM can benefit your company.Contact Us
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Pharmaceutical companies face a myriad of challenges during the long and complex processes involved in developing and manufacturing new drug substances.