Sterilization- biologics, proteins and peptides

David M. Bednarski, Ellen E. Lantz, Cedric E. Bobst, Anthony R. Eisenhut, Stephen J. Eyles, Julien P. Fey
“Sterilization of epidermal growth factor with supercritical carbon dioxide and peracetic acid; analysis of changes at the amino acid and protein level”

Technology Review

Soares GC, Learmonth DA, Vallejo MC, Davila SP, González P, Sousa RA, Oliveira AL
Supercritical CO2 Technology: The Next Standard Sterilization Technique?
Mater Sci Eng C Mater Biol Appl 99:520-540 (2019)

Cell Removal and Tissue Cleaning

Halfwerk FR, Rouwkema J, Gossen JA, Grandjean JG
Supercritical Carbon Dioxide Decellularised Pericardium: Mechanical and Structural Characterisation for Applications in Cardio-Thoracic Surgery
J Mech Behav Biomed Mater 77:400-407 (2018)

Casali DM, Handleton RM, Shazly T, Matthews MA
A Novel Supercritical CO2-based Decellularization Method for Maintaining Scaffold Hydration and Mechanical Properties
J Supercritical Fluids 131:72-81 (2018)

Antons J, Marascio MG, Aeberhard P, Weissenberger G, Hirt-Burri N, Applegate LA, Bourban PE, Pioletti DP
Decellularised Tissues Obtained by a CO2-philic Detergent and Supercritical CO2.
Eur Cell Mater 36:81-95 (2018)

You L, Weikang X, Lifeng Y, Changyan L , Yongliang L, Xiaohui W , Bin X
In Vivo Immunogenicity of Bovine Bone Removed by a Novel Decellularization Protocol Based on Supercritical Carbon Dioxide
Artif Cells Nanomed Biotechnol 46:334-344 (2018)

Duarte M, Silva I, Eisenhut A, Bionda N, Duarte AR, Oliveira A
Contributions of supercritical fluid technology for advancing decellularization and post processing of viable biological materials
Materials Horizons, Advance Article (2022)

Technology Review

Sawada K, Terada D, Yamaoka T, Kitamura S, Fujisato T
Cell Removal with Supercritical Carbon Dioxide for Acellular Artificial Tissue
J Chem Technol Biotechnol 83:943–949 (2008)

Huang YH, Tseng FW, Chang WH, Peng IC, Hsieh DJ, Wu SW, Yeh ML
Preparation of Acellular Scaffold for Corneal Tissue Engineering by Supercritical Carbon Dioxide Extraction Technology.
Acta Biomater 58:238-243 (2017)

Guler S, Aslan B, Hosseinian P, Aydin HM
Supercritical Carbon Dioxide-Assisted Decellularization of Aorta and Cornea
Tissue Eng Part C Methods 9:540-547 (2017)

Wang JK, Luo B, Guneta V, Li L, Foo SEM, Dai Y, Tan TTY, Tan NS, Choong C, Wong MTC
Supercritical Carbon Dioxide Extracted Extracellular Matrix Material From Adipose Tissue
Mater Sci Eng C Mater Biol Appl 75:349-358 (2017)

Seo Y, Jung Y, Kim SH
Decellularized Heart ECM Hydrogel Using Supercritical Carbon Dioxide for Improved Angiogenesis
Acta Biomater 67:270-281 (2018)

Harris, A.F., Lacombe, J., Liyanage, S. et al.
Supercritical Carbon Dioxide Decellularization of Plant Material to Generate 3D Biocompatible Scaffolds
Sci Rep 11, 3643 (2021)

Duarte, M.M., Ribeiro, N., Silva I.V, Dias, J.R., Alves, N.M., Oliveira, A.L.
Fast decellularization process using supercritical carbon dioxide for trabecular bone
The Journal of Supercritical Fluids,  Vol 172 (2021)

Sterilization – Microbial Inactivation

White A, Burns D, Christensen TW
Effective Terminal Sterilization using Supercritical Carbon Dioxide
Biotechnol123:504-515 (2006)

Qiu Q-Q, Leamy P, Brittingham J, Pomerleau J, Kabaria N, Connor J
Inactivation of Bacterial Spores and Viruses in Biological Material Using Supercritical Carbon Dioxide with Sterilant
J Biomed Mater Res Pt B:  Appl Biomater 91B:572-578 (2009)

Bernhardt A, Wehrl M, Paul B, Hochmuth T, Schumacher M, Schütz K, Gelinsky M
Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
PLoS One 10:e0129205 (2015)

Setlow B, Korza G, Blatt KM, Fey JP, Setlow P
Mechanism of Bacillus subtilis Spore Inactivation by and Resistance to Supercritical CO2 plus Peracetic Acid
J Appl Microbiol 120:57-69 (2016)

Bennet D, Harris A, Lacombe J, Brooks C, Bionda N, Strickland A, Eisenhut T, Zenhausern A
Evaluation of supercritical CO2 sterilization efficacy for sanitizing personal protective equipment from the coronavirus SARS-CoV-2
Science of The Total Environment Volume 780,(August 2021)

Scaffolds Impregnation

Champeau M, Thomassin JM, Tassaing T, Jérôme C
Drug Loading of Polymer Implants by Supercritical CO2 Assisted Impregnation: A Review
J Control Release 209:248-259 (2015)

Santos-Rosales V, Magariños B, Starbird R, Suárez-González J, Fariña J, Alvarez-Lorenzo C, García-González C
Supercritical CO2 technology for one-pot foaming and sterilization of polymeric scaffolds for bone regeneration
Intl J of Pharmaceutics Volume 605, (10 August 2021)

Santos-Rosales V, Magariños B, Alvarez-Lorenzo C, García-González C
Combined sterilization and fabrication of drug-loaded scaffolds using supercritical CO2 technology
Intl J of Pharmaceutics Volume 612, (25 January 2022)

Sterilization – Applications

Aortic valves

Hennessy RS, Jana S, Tefft BJ, Helder MR, Young MD, Hennessy RR, Stoyles NJ, Lerman A
Supercritical Carbon Dioxide-Based Sterilization of Decellularized Heart Valves
JACC Basic Transl Sci 2:71-84 (2017)

Hennessy RS, Go JL, Hennessy RR, Tefft BJ, Jana S, Stoyles NJ, Al-Hijji MA, Thaden JJ, Pislaru SV, Simari RD, Stulak JM, Young MD, Lerman A
Recellularization of a Novel Off-the-shelf Valve Following Xenogenic Implantation Into the Right Ventricular Outflow Tract
PLoS One 12:e0181614 (2017)`

Whole Lung

Balestrini JL, Liu A, Gard AL, Huie J, Blatt KM, Schwan J, Zhao L, Broekelmann TJ, Mecham RP, Wilcox EC, Niklason LE
Sterilization of Lung Matrices by Supercritical Carbon Dioxide
Tissue Eng Part C Methods 22:260-269 (2016)


Choe JA, Jana S, Tefft BJ, Hennessy RS, Go J, Morse D, Lerman A, Young MD
Biomaterial Characterization of Off-the-shelf Decellularized Porcine Pericardial Tissue for Use in Prosthetic Valvular Applications
J Tissue Eng Regen Med  12:1608-1620 (2018)

Amniotic Membranes

Wehmeyer JL, Natesan S, Christy RJ
Development of a Sterile Amniotic Membrane Tissue Graft Using Supercritical Carbon Dioxide
Tissue Eng Part C Methods 7:649-659 (2015)


Nichols A, Burns DC, Christopher R
Studies on the Sterilization of Human Bone and Tendon Musculoskeletal Allograft Tissue Using Supercritical Carbon Dioxide

J Orthopaedics 6:e9 (2009)

Irani M, Lovric V, Walsh WR
Effects of Supercritical Fluid COand 25 kGy Gamma Irradiation on the Initial Mechanical Properties and Histological Appearance of Tendon Allograft
Cell Tissue Bank 19:603-612 (2018)

Sun Y, Lovric V, Wang T, Oliver R, Walsh WR
Effects of SCCO2, Gamma Irradiation, and Sodium Dodecyl Sulfate Treatments on the Initial Properties of Tendon Allografts
Int. J. Mol. Sci. 202021(5), 1565;

Dental Membranes (pericardium)

Tovar N, Witek L, Neiva R, Marão HF, Gil LF, Atria P, Jimbo R, Caceres EA, Coelho PG
In Vivo Evaluation of Resorbable Supercritical CO2-Treated Collagen Membranes for Class III Furcation-Guided Tissue Regeneration
J Biomed Mater Res B Appl Biomater [Epub ahead of print]

Bone Products

Russell NA, Rives A, Pelletier MH, Bruce WJ, Walsh WR
The Effect of Sterilization on the Mechanical Properties of Intact Rabbit Humeri in Three-Point Bending, Four-Point Bending and Torsion
Cell Tissue Bank 14:231-242 (2013)

Russell NA, Rives A, Bertollo N, Pelletier MH, Walsh WR
The Effect of Sterilization on the Dynamic Mechanical Properties of Paired Rabbit Cortical Bone
J Biomech 46:1670-1675 (2013)

Russell N, Oliver RA and Walsh WR
The Effect of Sterilization Methods on Osteoconductivity of Allograft Bone on a Critical-Sized Bilateral Tibia Defect Model in Rabbits
Biomaterials 34:8185-8194 (2013)

Russell N, Rives A, Pelletier MH, Wang T, Walsh WR.
The Effect of Supercritical Carbon Dioxide Sterilization on the Anisotropy of Bovine Cortical Bone
Cell Tissue Bank 16:109-121 (2015)

Bui D, Lovric V, Oliver R, Bertollo N, Broe D, Walsh WR.
Meniscal Allograft Sterilisation: effect on Biomechanical and Histological Properties
Cell Tissue Bank 16:467-475 (2015)

Gerrit J. Van de Pol, Fiona Bonar, Lucy J. Salmon, Justin P. Roe, Leo A. Pinczewski
Supercritical Carbon Dioxide- Sterilized Bone Allograft in the Treatment of Tunnel Defects in 2-Stage Revision Anterior Cruciate Ligament Reconstruction- A Histological Evaluation
The Journal of Arthroscopic and Related Surgery Vol 34, Issue 3, p 706-713 (March 2018)

Jeremy Rajadurai, Vedran Lovric, Ralph J. Mobbs, Wen Jie Choy, William R. Walsh
The use of demineralised bone fibres (DBF) in conjunction with supercritical carbon dioxide (SCCO2) treated allograft in anterior lumbar interbody fusion (ALIF)
Journal of Spine Surgery  Vol 5, No 4 (December 2019)

William R. Walsh, Matthew H. Pelletier, Tian Wang, Vedran Lovric, Per Morberg, Ralph J. Mobbs,
Does implantation site influence bone ingrowth into 3D-printed porous implants?
The Spine Journal 19 (2019)

Alginate/Collagen Scaffolds

Bernhardt A, Wehrl M, Paul B, Hochmuth T, Schumacher M, Schütz K, Gelinsky M
Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
PLoS One 10:e0129205 (2015)

Absorbable sutures

Huie JL, Nichols JA, Fey JP, Burns DC, Potuck A, Chu CC.
Novel Supercritical Carbon Dioxide Sterilization of Absorbable Sutures and new Amino Acid-Based Biomaterials as Suture Coatings
NovaScience Publications.  Biodegradable Polymers. Volume 1: Advancement in Biodegradation Study and Applications, Chapter 14 pp.381-406 (2015)


Sikin AM, Walkling-Ribeiro M, Rizvi SSH
Synergistic Effect of Supercritical Carbon Dioxide and Peracetic Acid on Microbial Inactivation in Shredded Mozzarella-type Cheese and its Storage Stability at Ambient Temperature
Food Control 70:174-182 (2016)