Search research articles

Search research articles

Related Experiment Videos

Lyophilization cycle development for interleukin-2.

¹Cetus Corporation, Emeryville, CA 94608.

Developments in Biological Standardization

|January 1, 1992

Summary

This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Physical exertion exacerbates decline in the musculature of an animal model of Duchenne muscular dystrophy.

Proceedings of the National Academy of Sciences of the United States of America·2019

Same author

Comparison of assays for determination of peptide content for lyophilized thymalfasin.

The journal of peptide research : official journal of the American Peptide Society·2005

Same author

A screening technique to study the mechanical strength of gelatin formulations.

Drug development and industrial pharmacy·2000

Same author

The inhibition of capacitative calcium entry due to ATP depletion but not due to glucosamine is reversed by staurosporine.

The Journal of biological chemistry·1999

Same author

Characterization, stability, and formulations of basic fibroblast growth factor.

Pharmaceutical biotechnology·1996

Same author

Preparation and characterization of liposomes as therapeutic delivery systems: a review.

Pharmaceutica acta Helvetiae·1995

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Lyophilization of interleukin-2 (IL-2) is feasible within 30 hours. Optimized temperature and pressure conditions ensure the protein

Area of Science:

Biopharmaceutical Formulation
Protein Lyophilization
Process Optimization

Background:

Interleukin-2 (IL-2) is a critical cytokine for immune response.
Lyophilization (freeze-drying) is a common method for stabilizing protein therapeutics.
Understanding lyophilization parameters is crucial for maintaining protein integrity.

Purpose of the Study:

To investigate the impact of temperature and pressure on the lyophilization of human recombinant IL-2.
To determine optimal primary drying conditions for IL-2.
To assess the stability and quality of lyophilized IL-2.

Main Methods:

Differential scanning calorimetry (DSC) to determine collapse temperature (-25°C).
Lyophilization experiments with varied chamber pressures (100-300 mTorr) and shelf temperatures.

Related Experiment Videos

Analysis of lyophilized cake quality using Karl Fischer (residual moisture), RP-HPLC (monomeric content), and SDS-PAGE (oligomeric content).

Main Results:

Human recombinant IL-2 was successfully lyophilized in a pilot unit within 30 hours.
Lyophilization under varied primary drying conditions preserved IL-2 purity and potency.
Process uniformity was confirmed by assessing residual moisture across different cake locations.

Conclusions:

Lyophilization is a viable method for stabilizing human recombinant IL-2.
Optimized temperature and pressure conditions during primary drying maintain protein quality and efficacy.
Lyophilized IL-2 demonstrated stability for 12 months under study conditions.