The Role of Freeze-Drying in Biopharmaceutical Manufacturing: Stability and Efficacy
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".
Deadline for manuscript submissions: 20 February 2025 | Viewed by 181
Special Issue Editors
Interests: biopharmaceutical formulation and process development; biopharmaceutical quality control and characterization; protein chemistry and high order structure analysis
Interests: freeze-drying and spray-drying; co-amorphous systems; process analytical technology and quality by design; peptides and proteins in pharmaceutical formulations
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
We are pleased to invite you to submit original research articles or reviews to the Special Issue “The Role of Freeze-Drying in Biopharmaceutical Manufacturing: Stability and Efficacy”.
Biopharmaceuticals including monoclonal antibodies (mAbs), recombinant protein therapeutics, vaccines, and cellular and gene therapies (CGTs) are becoming new therapeutical modalities for the treatment and prevention of a variety of diseases over the past several decades. However, biopharmaceuticals are generally of marginal stability, and therefore, maintaining their structural and functional integrity is of paramount importance. Freeze-drying (FD) is the most widely employed drying technique to improve their stability. However, biopharmaceuticals are exposed to various stresses during the freeze-drying process (i.e., freezing, primary drying, and secondary drying). Therefore, the optimization of both the formulation and process variables is required.
This Special Issue aims to collect recent advances and applications of FD in biopharmaceutical manufacturing, mainly focusing on formulation and process optimization, as well as analytical technologies for processes and products. In this Special Issue, original research articles and reviews are welcome. Research areas may include (but are not limited to) the following:
- Current challenges and future opportunities in the FD of biopharmaceuticals;
- Development and optimization of FD formulations for biopharmaceuticals;
- Development and optimization of FD processes for biopharmaceuticals;
- FD process scale-up, technology transfer, and validation;
- Quality risk management for change management;
- Process analytical technology (PAT) for FD;
- Technologies for the characterization of the physical matrix and the biopharmaceuticals in the solid state.
We look forward to receiving your contributions.
Prof. Dr. Wei-Jie Fang
Prof. Dr. Holger Grohganz
Guest Editors
Manuscript Submission Information
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Keywords
- freeze-drying
- biopharmaceuticals
- process scale-up, technology transfer, and validation
- process analytical technology
- analytical techniques for FD products
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