Study of Chromatography Resin Storage

Oct 24,2025

Bestchrom

In biopharmaceutical downstream production processes, chromatographic purification has increasingly become an indispensable part, playing an irreplaceable role in improving product purity, impurity removal, and viral clearance. As the core component of these processes, the performance of chromatography resins directly affects product safety and efficacy, and conducting a robust resin storage study is the key step to ensure that the resin maintains stable performance during storage.

Why do we need to conduct storage studies for chromatography resins?

The purpose of a resin storage study is to verify the resin’s stability under the current storage conditions and to provide a scientific basis for defining storage conditions, shelf life, and re-test periods. Without an appropriate storage study, the resin’s performance may degrade; which might directly affect purification outcomes, thereby affecting drug-product quality and even safety and efficacy, and ultimately driving up manufacturing costs.

Regulatory requirements for resin storage studies

There is no single, unified regulatory standard for resin storage studies; however, because storage directly affects resin lifetime, multiple regulations and guidelines set forth relevant expectations. The core requirement is that storage studies must ensure stable resin performance throughout its period of use so as not to impact drug quality. The following regulations and guidance documents relevant to resin lifetime studies are provided for reference:

Table 1 Applicable Regulations, Guidance and Requirements for Chromatography Resin Lifetime Studies (Including Storage Studies)

Supplier-Conducted Shelf-Life Studies for Chromatography Resins

Each supplier conducts shelf-life studies on the resin in accordance with its SOPs; typical approaches are shown in Table 2.

Table 2 Examples of Supplier-Conducted Shelf-Life Studies for Chromatography Resins

Resin Storage Studies Conducted by Biopharmaceutical Manufacturers

Although chromatography resin suppliers may provide data on storage duration, as well as the antimicrobial and antifungal effectiveness of the shipping solution, additional storage validation studies are still required. This is primarily because the supplier’s storage data are generated using new, unused resin stored under unpacked conditions.

In most biopharmaceutical manufacturing processes, the chromatography resins being stored are typically used rather than new, and are often preserved directly in-column. Therefore, resin storage validation should take such practical conditions into account. In the early stages, storage studies were relatively simple and largely based on supplier recommendations and user experience. With the advancement of the biopharmaceutical industry—particularly the continuous strengthening of GMP requirements—resin storage studies have become increasingly systematic and scientifically structured.

An example of an operational approach for chromatography resin storage validation is shown below.

Table 3 Example of Chromatography Resin Storage Validation

Although specific practices for resin storage may vary among different companies and suppliers, several fundamental industry-wide consensus points have been established:

1. Resin storage strategies should be based on scientific research and experimental data rather than subjective judgment.

2. Conducting resin storage studies requires cross-functional collaboration among departments such as R&D, manufacturing, and quality management.

3. It should be recognized that resin storage validation is an integral part of the process validation lifecycle and must be continuously confirmed and optimized throughout routine use.

Considerations for Resin Storage Studies

Key points to note when conducting resin storage studies:

1. Conduct studies under conditions representative of actual storage (including temperature, humidity, and light exposure).

2. Define a justified sampling and testing frequency based on resin characteristics, storage mode (unpacked and/or in-column), and historical data.

3. Establish scientifically justified acceptance criteria.

4. Maintain comprehensive documentation (protocol, data, and results) to support regulatory submissions.

5. Ensure any changes to storage conditions during the study are assessed and approved through formal change control.

References

[1] FDA “Guidance for Industry：Process Validation: General Principles and Practices”

[2] EMA “CPMP Position Statement on DNA and Host Cell Proteins (HCP) Impurities, Routine Testing Versus Validation Studies,” CPMP/BWP/382/97

[3] PDA Technical Report No.60-3: Process validation: A lifecycle approach Annex 2: biopharmaceutical drug substances manufacturing. Parenteral Drug Association: 2021

[4] General Theory of Recombinant Monoclonal Antibody Products for Human Use, Part III, 2023 Edition of the Chinese Pharmacopoeia.