Transforming chemistry, manufacturing, and controls (CMC) submissions

Chemistry, Manufacturing and Controls (CMC) is an essential part of any pharmaceutical product application to the FDA or other regulatory authority and is critical to achieving a successful registration filing. A CMC dossier is intricate, and creating it takes considerable work.

The information included defines the manufacturing process as well as analytical procedures and specifications for release and stability of the product in addition to the primary manufacturing and packaging facility as well as its support utilities.

The traditional approach

The data included in the dossiers typically comes from unstructured data present in numerous systems and applications, including paper lab notes. It takes time and effort to obtain these.

Manual transcription for document creation using copy-and-paste is error-prone, results in discrepancies, and lacks traceability. To maintain data reliability, every single data point must be manually verified.

The creation of documents is an ongoing process. For instance, during ten to fifteen years of product development, development reports supporting the first submission of a Marketing Authorization Application are created and continue to be updated after submission.

For example, generating eCTD Module 3 of the CMC submissions that include product quality-related information takes, on average, more than 7000 hours.

Several specialists must work on the various sections of the same document while creating a complex CMC dossier. In traditional systems, reports and documents are shared via Google Docs or Dropbox, kept on a network drive or SharePoint, or distributed via email.

It is possible to lose or include the wrong version of a crucial document. This strategy is also not secure enough for very sensitive information, as it may enable intellectual property theft.

The effort required to produce CMC dossiers for New Drug Applications (NDA) or Marketing Authorization Applications (MAA) is high and includes non-profitable activities, so many organizations have outsourced them to specialized consulting firms, generating additional expenses.

Structured, automated, and collaborative

By moving away from static documents to data-centric automated dossier creation, BIOVIA offers a new strategy for CMC document creation. Documents are represented in BIOVIA Structured Document Manager using content and data.

Data lakes can be used to integrate all of the CMC dossier’s data, findings, and recommendations currently present in other systems. CMC documents can be created by pulling the data into the authoring tool, reviewing and then finalizing it before reusing it in one or more documents

Transforming chemistry, manufacturing, and controls (CMC) submissions

Figure 1. View of a structured document with different topics that different users can edit, freeze or release independently. Image Credit: BIOVIA, Dassault Systèmes

Rather than focusing on document preparation, users can now focus on content. The produced documents have improved quality, consistency, and accuracy, enabling customers to skip laborious and time-consuming data verification. Document creation and review thus become significantly more efficient.

Organizations can ensure that new submissions always contain the most up-to-date content. It is also simple to access any prior versions of data, meaning that a version of the dossier submitted and authorized by the Health Authorities can always be accessed.

With Structured Document Manager, online document authoring, editing, sharing, and live referencing are possible. Users within an organization and across the value network can collaboratively and intuitively create, version, and approve documents.

Technical documentation can be developed in a truly collaborative manner, thanks to the robust web-based authoring experience.

Transforming chemistry, manufacturing, and controls (CMC) submissions

Figure 2. Structured overview of document sections, showing the revision and maturity state, owner, modification date, and lock status. This allows easy collaboration and status overview at a glimpse. Image Credit: BIOVIA, Dassault Systèmes

Capabilities

  • Leverage multi-channel publishing to create documents in formats like HTML, PDF, Microsoft Word, etc.
  • Provide visibility on the impact of updating content and where it is used
  • Leverage flexible data representations with advanced table management and design
  • Standardize document layout, format, and content
  • Author and share documents across a value network chain
  • Reuse common content driving accuracy and consistency
  • Collaborate on document content securely and in a controlled manner
  • Automatically update documents in response to new information and events
  • Standardize report appearance, format, and layout

Gain NDA/MAA approvals easier and faster

By automating document creation, organizations in the biopharma industry can produce CMC dossiers faster and more accurately. Dossiers will contain current and up-to-date information.

Confidence in data quality and integrity permits companies to reduce tedious manual verification, providing time savings of 30-70%. Users can also collaborate in a secure environment that protects all critical IPs.

Organizations can streamline the production and management of scientific and medical documents with BIOVIA Structured Document Manager. This will lower prices, reduce the time-to-patient for life-saving medications, and speed up the process of getting agency authorities (such as the FDA) to give approval for a license for a drug product or substance.

Value

  • Reduce the time required to create the dossier’s stability, batch analysis, and specifications sections by 80%
  • Ensure current and up-to-date data in new submissions
  • Maximize transparency by direct access to source data and traceability
  • Reduce time to market
  • Rapidly produce documents by removing manual transfers (copy and paste)
  • Produce accurate reports through automated document generation
  • Save 30–70% of the time used by omitting manual data re-verification
  • Protect IP with a secure cloud-based collaborative environment

Transforming chemistry, manufacturing, and controls (CMC) submissions

Image Credit: BIOVIA, Dassault Systèmes

About BIOVIA, Dassault Systèmes

BIOVIA™ provides global, collaborative product lifecycle experiences to transform scientific innovation. Our solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the way we live.

The industry-leading BIOVIA portfolio integrates the diversity of science, experimental processes and information requirements, end-to-end, across research, development, QA/QC and manufacturing. Capabilities include Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics.

BIOVIA is committed to enhancing and speeding innovation, increasing productivity, improving quality and compliance, reducing costs and accelerating product development for customers in multiple industries.


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Last updated: Oct 11, 2022 at 9:44 AM

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