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Sterilization is traditionally one of the biggest bottlenecks in biologics manufacturing. The delicate nature of biologics creates challenges, and most conventional sterilization methods use harsh conditions that can degrade sensitive proteins like GLP-1 (glucagon-like peptide-1) and EGF (epidermal growth factor). Since these biologics cannot withstand standard sterilization techniques, manufacturers must seek alternative methods. Fortunately, supercritical carbon
Hydrogels are an innovative and versatile class of biomaterials that are pivotal in applications ranging from injectable therapies to advanced implants. Naturally, before they can be used for any medical or pharmaceutical function, they must be sterile. However, due to their unique properties, finding a suitable terminal sterilization method for hydrogels poses many challenges. That’s
When an experiment is compromised and discarded due to contamination, the result is countless hours of lost work and unusable data. Innovations in sterilization that can save money, shorten turnaround times, and improve outcomes are leading many organizations to reevaluate and upgrade their current approaches to R&D sterilization. However, justifying the acquisition of new laboratory
Research and development (R&D) is the lifeblood of innovation and advancements in medicine and science. As new technology, research avenues, and guidelines are introduced, it impacts how academic and corporate R&D teams in life sciences approach their work. In recent years, growing regulatory pressures and the pursuit of cost savings, shorter timelines, and enhanced outcomes
In the medical device industry, ensuring that products are sterile and remain so until use is a critical requirement. Packaging plays a crucial role in maintaining the sterility and integrity of medical devices. The interplay between packaging and sterilization is complex. As the industry moves away from ethylene oxide (“EtO”) to replacement modalities such as
Embracing Innovation Requires Intestinal Fortitude, an Understanding of History, and Measured Patience Every week, if not every day, you can find a headline claiming that the sky is falling because of pending restrictions on ethylene oxide (EtO) sterilization. Depending on what side of the issue you are on, it is either “you will die because
NovaSterilis, a pioneer in medical device sterilization using supercritical carbon dioxide (“scCO2”), has been awarded a $1.75 million SBIR (Small Business Innovation Research) Phase II grant by the NIAID (National Institute of Allergy and Infectious Diseases). This funding furthers the development of NovaSterilis’ scCO2 terminal sterilization platform for the pharmaceutical and biotechnology industries. This effort will
As decision-makers in the medical device and therapeutics industries, why do we do what we do? Sure, we want to make money and to some degree, stroke our ego. More likely, our primary driver is that we are wired to help our fellow humans. Our vision is straightforward – we want to improve people’s lives by
NovaSterilis, a leading innovator in medical device sterilization using supercritical carbon dioxide ("scCO2"), announces a collaboration with Dr. Jason Spector, M.D., Professor of Surgery and Chief of the Division of Plastic and Reconstructive Surgery at Weill Cornell Medicine, through New York State's Center for Advanced Technology (CAT) grant program. NovaSterilis and Dr. Spector's research group will embark on an important regenerative medicine research initiative.
Sterility Assurance Level is typically an afterthought but can significantly impact product development schedules. Integrating sterilization strategies early on is vital for ensuring successful and timely introductions. In this article, Tony Eisenhut, CEO of NovaSterilis emphasizes the importance of considering sterilization in the early stages of R&D for new medical devices or therapeutics. Exploring Alternatives for Effective
Ethylene oxide sterilization is a broadly used method within the industrial and healthcare industries for sterilizing a wide range of products. However, its potential environmental and health effects have raised concerns among advocacy groups and government agencies. In this article, Tony Eisenhut, CEO of NovaSterilis, stresses the importance of finding better alternatives to EtO sterilization.
Supercritical CO2 (scCO2) sterilization is a safe and highly efficient method for sterilization with many applications in the MedTech industry. While ethylene oxide (EtO) has long been the leading industrial sterilization modality, its emissions have raised concerns regarding its impact on human health and the environment. In this context, scCO2 has emerged as a promising
October 1, 2019 Advanced Regenerative Medicine Institute (ARMI) features NovaSterilis in its new member spotlight. https://www.armiusa.org/news/2019/10/1/new-member-spotlight-novasterilis
November 25, 2019 The FDA chooses NovaSterilis to work directly with the FDA on new approaches to medical device sterilization focused on identifying alternatives to ethylene oxide (EtO) sterilization methods. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies
February 2, 2020 NovaSterilis technical team co-authors paper published in Biochimica et Biophysica Acta (BBA) – Proteins and Proteomics titled “Sterilization of epidermal growth factor with supercritical carbon dioxide and peracetic acid; analysis of changes at the amino acid and protein level” https://www.sciencedirect.com/science/article/abs/pii/S1570963919302195
February 18, 2020 NovaSterilis places NovaGenesis benchtop supercritical CO2 system at Universidade de Santiago de Compostela prior to the university hosting “EIFS 2020, the First Iberian Meeting on Supercritical Fluids” https://flucomp.es/eventos/eifs2020
August 1, 2020 Surfaces in Biomaterials Foundation Summer 2020 newsletter chronicles NovaSterilis’ and iFyber’s rapid mobilization of resources to address demands for reprocessing of PPE in support healthcare providers through COVID-19 pandemic. https://www.surfaces.org/resources/Documents/SurFACTS/2020/SurFACTS%20Summer%202020.pdf
August 21, 2020 The FDA issued an emergency use authorization (EUA) to NovaSterilis, Inc. for its Nova2200, which uses the NovaClean decontamination process. Nova2200 can be used to decontaminate compatible N95 respirators for single-user reuse by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) during
February 9, 2021 NovaSterilis will present at the Advanced Regenerative Manufacturing Institute’s workshop on March 11, 2021. The workshop topic is Scaffold Fabrication Tools and Equipment. Tony Eisenhut, CEO of NovaSterilis, will present Supercritical Carbon Dioxide: A Terminal Sterilization Solution for Bio-based Materials. Register for the event at https://www.armiusa.org/events/2021/2/11/a-template-for-the-future-of-biomanufacturing-virtual-workshop-series-zh2np
February 13, 2021 NovaSterilis working with medical device manufacturers and regulators to reduce EO emissions. https://www.packagingdigest.com/medical-packaging/medical-device-makers-see-progress-eo-sterilization
December 21, 2021 NovaSterilis and iFyber researchers collaborate with Universidade Catolica Portuguesa and Universidade Nova de Lisboa on a technology review publication that identifies contributions of supercritical fluid technology for decellularization of biological materials. https://doi.org/10.1039/D1MH01720A