Freeze Drying Technology: Recent Advances, Innovations and Applications

Guest Editors:
Shreya Kulkarni, Ph.D., AbbVie Biotherapeutics Inc., United States
Harshil Renawala, Ph.D., Merck & Co., Inc., United States
Alina Alexeenko, Ph.D., Purdue University, United States
Akhilesh Bhambhani, Ph.D., Ultragenyx Pharmaceutical Inc., United States
Bakul Bhatnagar, Ph.D., Pfizer Inc., United States
Robin Bogner, Ph.D., University of Connecticut, United States
Xiuling Lu, Ph.D., University of Connecticut, United States

Submission Status: Open | Submission Deadline: 30 April 2025

AAPS Open is calling for submissions to our Collection on "Freeze Drying Technology: Recent Advances, Innovations and Applications".

Since the early industrial applications of freeze-drying plasma and penicillin to improve storage stability and transportation during World War II, tremendous progress has been made in the commercial freeze-drying technology to manufacture sensitive therapeutics and enable access of shelf-stable medicines to patients globally, with hundreds of lyophilized drug products approved and commercialized to date. While technological advances have improved efficiency of the modern freeze-drying process, several novel drying technologies have emerged as alternatives to conventional vial-based freeze-drying, with potential to enable new product types and expand manufacturing scale. On behalf of the Editorial Team for AAPS Open and the American Association of Pharmaceutical Scientists, we are pleased to announce the August 2025 special issue on Freeze Drying Technology: Recent Advances, Innovations and Applications to highlight the current state-of-the-art and future directions of pharmaceutical drying technologies.

The Guest Editors are also pleased to announce the dedication of this special issue honoring the work of Dr. Steven L. Nail. Dr. Nail is recognized as one of the world’s leading experts and a luminary in freeze drying technology, whose expansive contributions spanning an almost five-decades-long career have shaped the field of industrial pharmaceutical freeze drying as we know today. His distinguished career, marked by significant contributions as both an industry scientist and academic researcher, has yielded several groundbreaking publications and inventions that have become integral to contemporary freeze-drying technology. His teaching and mentorship have inspired generations of students and scientific leaders alike. Dr. Nail is a Fellow of the American Association of Pharmaceutical Scientists (AAPS) and has earned several accolades, including the 2007 AAPS Research Achievement Award in Pharmaceutical Technology. Dr. Steven L. Nail can be described in many ways: a scientist par excellence, a mentor, a colleague, a friend, but above all, he is an exceptionally kind human being.

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Meet the Guest Editors

Shreya Kulkarni, Ph.D., AbbVie Biotherapeutics Inc., United States
(Issue Co-Lead) Shreya Kulkarni is a Principal Research Scientist at AbbVie Biotherapeutics Inc., where she supports formulation and process development of biologic drug products including monoclonal antibodies, bispecifics, trispecifics, antibody drug conjugates and ultra-low dose protein products. In addition to lyophilization, her research interests also include alternate drying technologies such as spray drying and spray freeze-drying. She also serves as the Chair of the Lyophilization Working Group in the IQ Consortium.

Harshil Renawala, Ph.D., Merck & Co., Inc., United States
(Issue Co-Lead) Harshil Renawala is a Senior Scientist at Merck & Co., where he is involved in process development and commercialization of biologics drug products, particularly focused on lyophilization process. His research interests also include alternate drying technologies such as microwave freeze-drying and spray drying of biologics and vaccine therapeutics, and characterization of protein stability in the solid-state.

Alina Alexeenko, Ph.D., Purdue University, United States
Alina Alexeenko is Professor at the School of Aeronautics and Astronautics and Davidson School of Chemical Engineering at Purdue University. She is a founding co-Director of Advanced Lyophilization Technology Hub – LyoHUB established in 2014 and focused on advancing the science and technology of lyophilization for manufacturing pharmaceuticals and vaccines. Her research is in rarefied gas dynamics, heat and mass transfer process engineering in application to spacecraft technologies, vacuum systems and pharmaceutical manufacturing.

Akhilesh Bhambhani, Ph.D., Ultragenyx Pharmaceutical Inc., United States
Akhilesh Bhambhani is Vice President of Technical Development, Global CMC Development and Technical Operations at Ultragenyx Pharmaceutical Inc. In his current role, Akhilesh is responsible for providing strategic leadership, technical prowess, and operational guidance for global CMC development of the company’s pipeline molecules and drug candidates, spanning mRNAs, ASOs, proteins, antibodies, and small molecules, from preclinical stages through Phase III clinical trials and commercialization. Additionally, he also serves as Professor of Practice (Gratis) UCONN(Storrs, CT), BoD member at BioTechnique (York, PA) and is an affiliate of the Lawrence Berkeley Laboratory (Berkeley, CA).

Bakul Bhatnagar, Ph.D., Pfizer Inc., United States
Bakul Bhatnagar is an Associate Research Fellow within BioTherapeutics Pharmaceutical Sciences at Pfizer, where he supports formulation and process development of biologics, including the development of alternate drying technologies. His research interests include formulation, process development, and characterization of small and large molecule freeze-dried drug products. Additionally, he also serves on the BoD at ISL-FD (International Society of Lyophilization – Freeze Drying, Inc.).

Robin Bogner, Ph.D., University of Connecticut, United States
Robin Bogner is faculty at the University of Connecticut serving as Professor at the School of Pharmacy and member of the Institute of Materials Science. She also directs the multi-university/industry research consortium -- Dane O. Kildsig Center for Pharmaceutical Processing Research (CPPR). Her current research interests include lyophilization formulation and process development.

Xiuling Lu, Ph.D., University of Connecticut, United States
Xiuling Lu is Professor at the University of Connecticut and Associate Director of Center for Pharmaceutical Processing Research (CPPR). Her research is focused on innovative nanotechnologies that target difficult-to-treat cancers, nanoparticle stabilization, optimization and evaluation of drug formulations and pharmaceutical processing, as well as the use of versatile imaging tools to improve pharmaceutical product quality.

About the collection

The Guest Editors have developed a scope for the dedicated issue and are particularly interested in articles encompassing the following topic areas:

- Advances, innovations and applications of existing and emerging pharmaceutical drying technologies including lyophilization, lyospheres or lyobeads, spray drying, spray freeze-drying, microwave freeze-drying, spin freeze-drying, foam drying, thin film freeze-drying and microglassification, etc.; advantages, disadvantages and barriers to commercial application; criterion for performance comparison with conventional freeze drying and current technology or manufacturing readiness levels; applications in continuous manufacturing and considerations for improving process efficiency and energy utilization.

- Pharmaceutical formulations and processing of biologics, vaccines and small molecule therapeutics in the dried form including but not limited to monoclonal antibodies, bi- and tri-specific antibodies, fusion proteins, protein-drug conjugates, enzymes, oligonucleotides, live-virus vaccines, cell therapy products, small molecule therapeutics and diagnostic reagents; mechanistic understanding of solid-state stabilization in amorphous or crystalline formulations; effects on product critical quality attributes and stability; considerations for drying drug encapsulated delivery systems (e.g., LNP’s, liposomes) and drug-device combination products.

- Analytical characterization methods to analyze the molecular structure, stability attributes and material properties of the drug product in the solid-state including but not limited to ssNMR, ssHDX-MS, ssFTIR, NIR, DSC, PXRD, polarized light microscopy, X-ray microscopy, SEM, surface area by BET gas adsorption, mercury intrusion porosimetry, Karl Fisher titration, chromatography, sub-visible and visible particle analysis, etc.

- Equipment considerations for pharmaceutical drying operations at laboratory, pilot and commercial scales; process analytical technologies (PAT) and modeling (first principles heat and mass transfer, computational fluid dynamics) approaches for process design, optimization, control and validation; scale-up and technology-transfer for commercial manufacturing.

- Regulatory agency considerations and industry best practices for development of dried pharmaceuticals.

There are currently no articles in this collection.

Submission Guidelines

AAPS Open and the Guest Editors will welcome original scientific articles (i.e., Research Articles, Reviews and Mini Reviews, Rapid Communications, Notes and Commentary) within the scope of the dedicated issue. We encourage individuals interested in contributing articles relevant to the scope to contact Dr. Harshil Renawala (Harshil.Renawala@merck.com) or Dr. Shreya Kulkarni (Shreya.Kulkarni@abbvie.com). We encourage and anticipate Dr. Steve Nail’s many colleagues, collaborators, students, friends, and readers to contribute articles to this dedicated issue in his honor. The Guest Editors will accept submissions until 30^th April 2025, with some flexibility, to allow time for the peer-review and revision process before the release of the special issue in August 2025.

Before submitting your manuscript, please ensure you have read our submission guidelines. Articles for this Collection should be submitted via our submission system. During the submission process, under the section additional information, you will be asked whether you are submitting to a Collection, please select "Freeze Drying Technology: Recent Advances, Innovations and Applications" from the dropdown menu.

Articles will undergo the journal’s standard peer-review process and are subject to all of the journal’s standard policies. Articles will be added to the Collection as they are published.

All articles published in AAPS Open are freely and permanently accessible online immediately upon publication, without subscription charges or registration barriers. AAPS Open's open access policy ensures maximum visibility of articles as they are available to a wide, global audience. The journal currently levies an article-processing charge of £1290.00/$1990.00/€1690.00 for each article accepted for publication. For further information, please visit the journal's section on Fees and Funding.

The Guest Editors have no competing interests with the submissions which they handle through the peer review process. The peer review of any submissions for which the Guest Editors have competing interests is handled by another Editorial Board Member who has no competing interests.