The road to a successful approval and launch of a new medicinal product is long and fastidious. Clinical and non-clinical activities only represent a portion of the work necessary to ensure the product is safe for the patient. Chemistry, Manufacturing and Controls (CMC) information is collected from the early development to the approval of the Marketing Authorization and beyond once the product is commercialized to ensure a product delivered to the patient is safe and effective, that it meets the appropriate standards, and is manufactured consistently from clinical to commercial batches.
Where is CMC data used?
At first, CMC data is used internally within a biopharmaceutical company to ensure the continuity of the development of the medicinal product. Internal reports are generated to retrace the experiments performed and to document the decisions taken during the pharmaceutical development. In addition, those internal documents report any changes that are made.
When a medicinal product is in the clinical phases, CMC data is regrouped in Regulatory Dossiers such as the Investigational New Drug (IND) or Investigation Medicinal Product Dossier (IMPD) etc. Those dossiers are submitted to the Health Authorities. The CMC data is usually a synthesis of all the CMC obtained at the time of submission. It may be revised depending on the necessity.
Drug manufacturers work hard from concept to patient: They create and optimize formulated products, gain regulatory approvals and manage consumer medicine deliveries. The complexity of the drug lifecycle increases with frequent mergers, acquisitions and quality and regulatory compliance requirements (e.g., ISO IDMP and ICH Q12), presenting a challenging innovation environment for companies. More agile and integrated approaches to product development and commercialization are now necessary, especially when changes occur and assessing impact becomes exceptionally critical.
With up to 1,000 medicinal products per substance or brand, the number of interconnected product-related changes per year in a company is crucial. When these cases arise, the biopharmaceutical companies may submit variations to the initial submissions, and therefore impacts CMC.
What does CMC cover?
CMC data cover the raw data from the laboratory notebook to the internal reports such as stability study reports, investigations, substance characterization, process development reports etc. It also covers the actual sections that are submitted to the Health Authorities as part of the clinical studies or later as part of the Marketing Authorization approval to sell the product on the market to the wider population.
Since the development of a medicinal product spans over years, the related raw data is often found on multiple supports (Electronic Laboratory Notebooks, Laboratory Information Management Systems etc.). Also because the studies can happen in different laboratories, such as Contract Research Organization (CRO) or Contract Manufacturing Organization (CMOs).
When data is used in an internal report, data verification is essential to ensure integrity.
CMC data is often used in internal reports, such as stability study reports, analytical method validation reports, or process validation reports. Those internal reports often serve as intermediate reports for the compilation of the dossier that is prepared for the INDs or IMPDs and for the Marketing Authorization Dossiers such as NDAs, ANDAs, MAAs.
What are the challenges?
CMC data is currently unstructured. The traceability of the data can be challenging, stored in multiple sources. Biopharmaceutical companies need to ensure that they are capable to trace the data all the way back to the laboratory notebook. This is a challenge when data is generated on multiple supports, by multiple laboratories. To generate the internal reports and the various sections of the regulatory dossiers, experts need to manually transcribe the data, and a second person needs to verify the entered data. This process is highly time consuming and error-prone.
How can BIOVIA help?
BIOVIA provides a solution for collaborative Structured Document Management, which automates the creation of documents, for example CMC dossiers. Moving away from static documents, structured templates are autopopulated with relevant, existing data. CMC documents can be compiled by pulling the data into the authoring pool, reviewing and finalizing it. The data is traceable from its source to its final use. Common content can be reused driving accuracy and consistency in several documents. Authoring and sharing content can be standardized and automatically updated in response to events and new data in a secure and controlled manner. Users can now focus on more valuable work while documents are consistent, accurately structured and of improved quality.