US FDA offers guidance on analytical procedures and methods validation for biologics

By Zachary Brennan

- Last updated on GMT

Related tags Food and drug administration Fda

US FDA offers guidance on biologics
The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies. 

The recommendations in the guidance​ apply to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications.

The FDA notes that this revised draft guidance does not address investigational new drug application (IND) methods validation, “but sponsors preparing INDs should consider the recommendations in this guidance​.”

The draft focuses on:

  • Analystical methods development;
  • Content of analytical procedures;
  • Reference standards and materials;
  • Analytical method validation;
  • Statistical analysis and models;
  • Life cycle management of analytical procedures; and
  • FDA methods verification.

The revised draft stops short of addressing specific method validation recommendations for biological and immunochemical assays for characterization and quality control of many drug substances and drug products. “For example, some bioassays are based on animal challenge models, and immunogenicity assessments or other immunoassays have unique features that should be considered during development and validation​,” the agency says.

In addition, the need for revalidation of existing analytical methods may need to be considered when the manufacturing process changes during the product’s life cycle​,” the FDA added.

Each BLA must include a full description of the manufacturing methods, including analytical procedures that demonstrate the manufactured product meets prescribed standards of identity, quality, safety, purity, and potency.

In anticipation of life cycle changes in analytics, an appropriate number of samples – based on scientific principles and risk assessment -- should be archived to allow for comparative studies. For complex products that are sensitive to manufacturing changes, “archived samples can be an important tool to make these comparisons​,” and they should include samples that represent pivotal clinical trial material and marketed product, according to the FDA.

For certain biologics, samples of the product for licensure along with summaries of results of tests performed on the lots represented by these samples should be submitted. The FDA laboratory verifies the performance of the methods and the results, and during a pre-BLA meeting or after submission of the BLA, the FDA laboratory can send industry a request to provide standards, controls, reagents, material safety data sheets, and supplies.

This revised draft guidance, which was first released 2000, also is meant to complement the International Conference on Harmonisation guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and validating analytical methods. 

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