Small and mid-sized biotech companies often turn to experienced contract manufacturing organizations to produce their investigational compounds. As a CMO, it’s critical to be thorough and transparent with your biotech clients to make their IND applications a success and set them up for efficiency at later stages of the FDA regulatory process.

Strict Quality Control and Qualification Processes Can Help

Dedicated quality control and qualification professionals can review your plans and execute various quality checks to ensure your facilities are primed for IND success and that all reporting and documentation mechanisms are in places to capture the information your biotech clients will need.

Of most importance is the Chemistry, Manufacturing, and Control (CMC) portion of the IND application. The FDA describes the purpose of the CMC section of the IND application:

“Throughout the life cycle of an IND application and in each phase of the investigation, sufficient information should be submitted to assure the proper identification, quality, purity, and strength of the investigational drug. The amount of information needed to make that assurance will vary with the phase of the investigation, the proposed formulation, and duration of the investigation.”

Sections of the IND application related to manufacturing and quality include:

Drug Substance

  • Name and address of manufacturer.
  • Description of the general method of preparation of the drug substance, including a list of the reagents, solvents, and catalysts used. A detailed flow diagram is suggested as the most effective presentation. More information may be needed to assess the safety of biotechnology-derived drugs or drugs extracted from human or animal or plant sources.
  • The acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug substance, with a brief description of the test methods used (e.g., Nuclear Magnetic Resonance, Infrared, UV spectra to prove the identity, and High Performance Liquid chromatograms to support the purity level and impurities, etc.). Submission of certificates of analysis is also suggested.

Drug Product

  • A list of all components and composition used in manufacturing process, including reasonable alternatives for inactive compounds used in the manufacture of the investigational drug product. This list is expected to include both those components intended to appear in the drug product and those which may not appear, but which are used in the manufacturing process.
  • Summary of quantitative composition of the investigational new drug product, including any reasonable variations that may be expected during the investigational stage.
  • Brief general description of the manufacturing process (in the form of a flow diagram is suggested) and packaging procedure, as well as other relevant tests, as appropriate for the product. Final specifications for the drug product intended to be used in toxicological and clinical studies should be included. For injectable products, sterility and pyrogenicity tests, endotoxin levels and particulate matter should be included. Submitting a copy of the certificate of analysis of the clinical batch is also suggested.
  • The acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug product.

Placebo Formulation

  • This section is expected to include a brief general description of the composition, manufacture, and control of any placebo formulation to be used in the proposed clinical study. The description may be structured similarly to the description of the drug product recommended above.



  • This section is expected to include an assessment of effects of the investigational product on the environment. Most products qualify for a categorical exclusion from such an assessment. Granting of a categorical exclusion will also depend upon the size of study population and amount of active moiety manufactured for the study.

Find official and up-to-date IND application guidance from the FDA here.

Are You Set Up to Help Your Clients Succeed?

While CMC section requires a minimum amount of data for the application, being more thorough here will pay off in shorter time-to-market and lower costs of expensive later-stage trials.

Here are some things to keep in mind to help your biotech clients complete their IND application efficiently and avoid any significant issues during the process.

  • Provide as many details as possible about the manufacturing process and analytical controls used in production.
  • Follow cGMP practices that are required for phase 1 trials. The more knowledge and quality control you can demonstrate, the better.
  • Expect to have conversations with the FDA about the CMC contents.
  • Demonstrate the use of state-of-the-art technologies, a history of compliance, and on-time delivery.

Are Your Processes Up to Speed?

As a CMO, you play a critical role in achieving IND approval for your biotech clients who rely on you for this expertise.

Proving your expertise in balancing budgets, accelerating project timelines, and achieving regulatory compliance is critical to your success and that of your clients.

Contact us to learn how we support CMOs with the critical project controls experience to get the job done right the first time.