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Lyophilized Formulation

Sterile powder for injection made by freeze-drying method is called lyophilized formulation, which is one of the important alternatives to liquid formulations. Any drug that is unstable at room temperature (e.g. interferon, coenzyme A and blood products) needs to be made into lyophilized formulation. Since biopharmaceutical molecules are usually inherently unstable, which is mediated by the most commonly used excipient, water. Therefore, the development of liquid formulations may not always be successful, and lyophilized formulations are the only way to achieve a stable product.

Lyophilized Formulation

Our Services

CD Formulation has the experience and technical capability to develop both liquid and lyophilized formulations step-by-step or simultaneously, tailoring formulation development to fit your time and budget. We can provide complete lyophilization process development, including the selection of appropriate excipients, bulking agents and buffers. In addition, we offer an extensive portfolio of analytical techniques for the physicochemical characterization of lyophilized products, ensuring that the lyophilization process will operate under optimal conditions and that the final product will meet the highest quality standards. Some of the services we can offer you include:

You can contact our experts to learn how we can help your product development become a success story. Our CD Formulation team is a leading expert in all aspects of pharmaceutical formulation development and dosage form optimization, and can design formulations for lyophilized formulation based on API properties and customer development objectives. CD Formulation can provide you with one-stop services to meet your needs of lyophilized formulation.

Advantages of Lyophilized Formulation

1. The product is stable over a very wide temperature range, so it can be used in all climates and conditions while maintaining the integrity of the sample.

2. Improved data quality and reliability of results through pre-assigned single-dose assays, while also reducing the risk of contamination.

3. Fewer sample handling and pipetting steps are required, simplifying the end-user's workflow.

4. Transportable without refrigeration, reducing shipping costs.

5. Less hazardous to transport than wet reagents and does not require special permits.

How to Contact Us?

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

  1. Huang, M., et al. Investigation of Fogging Behavior in a Lyophilized Drug Product-ScienceDirec. Journal of Pharmaceutical Sciences, 2019, 108( 3):1101-1109.
  2. Jin, L., et al. The Research Progress of Freeze-Drying Technology and Lyophilized Antibody Drugs[J]. Journal of Liaocheng University(Natural Science Edition), 2019.
  3. Zdravkovic, S. A. Assessment of Patient Exposure to Leachables From Lyophilized Drug Formulations Following Reconstitution, Storage, and Administration via Polymeric Packaging/Delivery Systems[J]. Journal of pharmaceutical sciences, 2019, 11: 2837-2846.

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Please note: Our products and services can only be used for research purposes. Do not use in diagnostic or therapeutic procedures!

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