Drug products used for clinical trials are referred to in Europe as investigatory medicinal products (IMPs) and are controlled by legislation requiring their manufacture in facilities that pass inspection by the appropriate regulators. The US FDA regulates the manufacture of drugs for clinical trials in their document entitled: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH Topic Q7A) and requires that manufacturing companies have CGMP to produce active pharmaceutical ingredients (APIs). Such controls are necessary to ensure the same level of purity of drugs as is found when they are manufactured for widespread marketing, thus protecting the test subjects participating in clinical trials.
As a result, manufacturing facilities with CGMP are increasingly in demand. Small biotech startups with new discoveries entering clinical trials will likely not have the facilities money or time to produce APIs that comply with regulations for their trials. Thus, the CSO market is booming as contract manufacturing organizations (CMOs) obtain the credentials to fulfill this need.
For more details, see the ICH Topic Q7A GMP Guidance for APIs and the European Commission's Rules for Governing Medicinal Products in the European Union.
Comments
I work in exactly this line of work, managing manufacturing and quality for clinical trials materials. Your comments maintain some common misperceptions about CGMP. First, the concern about the manufacturing facility is only one part of CGMP. Control of materials, processes, test methods, documents and records, and personnel/training are all equally essential components, and these along with extensive qualification and validation programs are what makes a full CGMP system. Second, the FDA approaches CGMP compliance on a “sliding scale,” acknowledging that not all components of full CGMP need be implemented for product in phase 1 or 2 trials where manufacturing methods and formulation may still be part of the research program. Participants in the clinical trials are protected by good QC testing knowledge of the product, rather than by having the API produced from fully compliant facilities and processes. Here is one FDA reference to support this position: http://www.fda.gov/cder/guidance/6164dft.htm.
Regards,
Lee McDonald