Virus inactivation ppt

SPEE3D is one of the participants in this program. The authors also acknowledge the support of BioLabs Pty Ltd. National Center for Biotechnology Information , U. Manuf Lett. Published online Aug Stephanie Hamilton c BioLabs Pty.

Angela Luttick c BioLabs Pty. Author information Article notes Copyright and License information Disclaimer. Published by Elsevier Ltd. All rights reserved. Elsevier hereby grants permission to make all its COVIDrelated research that is available on the COVID resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source.

This article has been cited by other articles in PMC. Abstract In this work, cold-spray technique was employed for rapid coating of copper on in-use steel parts. Experimental procedure 2. Open in a separate window. Material characterization A Taylor Hobson Profilometer 7. SARS-CoV-2 viricidal activity test The virucidal activity of copper was determined in vitro by exposure of the virus to copper.

Results and discussion 3. Cold-spray copper coatings Stainless steel push plate Fig. Table 1 Evaluation of virus titres with respect to the exposure time. Viricidal effect of 3D-printed Copper-coated and stainless steel metallic surfaces.

Conclusions This work highlights the application of cold-spray process to fabricate copper coatings onto in-use steel push plates in about 7 mins, with total time for re-deployment within 17 mins.

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Footnotes 1 Chemical composition: References 1. N Engl J Med. Ong S. The Lancet. Infectious diseases, p. Isolation, quarantine, social distancing and community containment: pivotal role for old-style public health measures in the novel coronavirus nCoV outbreak. Journal of Travel Medicine, Grass G. Metallic copper as an antimicrobial surface. Appl Environ Microbiol. Noyce J. Victor C.

Kinetically deposited copper antimicrobial surfaces. Warnes S. Stier O. Fundamental cost analysis of cold spray. J Therm Spray Technol. PowerPoint PPT presentation free to view. Validation of Virus Removal - Viral clearance studies should not be done in the production facility. Anti-tumor immunity - Anti-tumor immunity Regulatory T cells prevents removal of cancer cells and thus contribute to the development of the tumor.

Regulatory T cells prevents removal of Removal of Pathogenic Bacteria by Wetlands Enteric Pathogens and Pathogenesis. Skin infection. Staphylococcus aureus Pathogen Biology The E. Co-ordinate gene regulation. Antisepsis: Removal of pathogens from Bacteriostasis: Inhibiting, not killing, microbes.

MCB , Spring - Killing or removal of all living. Update on viral inactivation - the efficacy of CSL's dedicated viral inactivation and removal steps in the Donor screening is still the cornerstone of viral safety Identification of the pathogen 6. Control of Microbial Growth - Sterilization: Removal of all microbial life Filtration removes microbes Bacteriostasis: Inhibiting, not killing, microbes Chapter 22 - Pathogens - Chapter 22 - Pathogens Objectives Be able to describe the difference between a frank and opportunistic pathogen Be able to list the five modes of transmission of Still, throughout the low pH titration study for viral inactivation, sample extraction is required for offline analysis to document various quality attributes such as aggregation or deamidation through methods such as Size Exchange Chromatography SEC.

Although precision is possible from skilled scientists, the viral inactivation process is typically laborious and suffers from the natural variations, inaccuracies and challenges of reproducibility of any manual process. While the principal need for low pH viral inactivation studies in downstream bioprocessing is to define the scope of reagent addition and time needed for the process, characterization of process kinetics and the impact of compounding process parameters is also of importance and ultimately a requirement to ensure design of a viral inactivation process which is both robust and optimized.

Yet, temperature monitoring and control is often an overlooked, and therefore, an uncontrolled parameter during process development studies for viral inactivation. This oversight may be due in part to the use of pilot or even commercial manufacturing-scale systems which perform viral inactivation in hold or transfer vessels which might record but not control temperature.

Representativeness of scale, in particular representativeness of mixing is often another parameter easily overlooked in low pH viral inactivation studies such as those performed via manual platforms controlled by magnetic stir plates. Lack of data capture for something as simple as mixing makes it impossible to verify if the assumed conditions of the study were correct and consistent.

The low pH treatment for virus inactivation unit operation presents a potential risk for in-process product aggregation during downstream processing for a monoclonal antibody. Presented by Hiren D. Ardeshna of GlaxoSmithKline, this presentation discusses a full-factorial experimental design to investigate the effect of four process parameters:. Solvent or detergent viral inactivation methods are commonly employed against enveloped viruses.

Reagents used generally have negligible impact on the lability of the therapeutic protein or antibodies which are subject to the challenges of denaturation or deamidation possible with some low pH methods. Solvent or detergent treatment methods for viral inactivation have many of the same needs and drivers as low pH methods; principally to define the scope of reagent addition in this case a solvent or detergent and time needed for the process. As with low pH viral inactivation, conditions vary between immunoglobulins or other Drug Substance DS types.

Therefore, studies must be undertaken for each molecule to characterize and validate the design space or the operational boundaries in which effective solvent or detergent viral inactivation can take place.

These boundaries and the outcome of a viral inactivation process are similarly defined by Critical Process Parameters CPPs including temperature, protein content, solvent or detergent content, time at inactivation conditions, as well as mixing and effectiveness of solvent or detergent homogenization.

While detergent viral inactivation studies do not require the same manner of reagent titration as low pH studies, a design space of critical variables still needs to be evaluated. As with low pH, viral inactivation studies utilizing solvent or detergents traditionally characterize the process entirely manually.

Reagent dosing and controls are similarly dependent on the accuracy and precision of highly skilled persons simultaneously performing multiple critical tasks. Solvent or detergent viral inactivation studies are likewise subject to natural variations, inaccuracies and challenges of reproducibility. Viral inactivation methods relying on solvents or detergents generally require a further point of consideration not typically pertinent to low pH methods.

Any added solvents or detergents must be removed from the Drug Substance DS or immunoglobulin solution and verified by an appropriate analytical method. Typically, solvents or detergents are removed via either chromatography or buffer exchange via tangential flow filtration. The removal of added solvents or detergents is somewhat analogous to purpose for reverse-pH titration from a low pH inactivation back to within an appropriate physiological or slightly basic range.

At scale, buffer exchange or chromatographic methods would likely occur as continuous or semi-continuous unit operations as the material moves from a hold vessel through a column or other appropriate membrane for solvent or buffer exchange.

In process development, the solvent or detergent viral inactivation is likely to occur separate and distinct from the following purification or removal step. As such, data or information continuity can be compounded by this practice. Various vaccine products undergo viral inactivation, including toxoid, recombinant-protein, sub-unit, polysaccharide, and even a select few virus-like particle vaccines.

Again, the selection of an appropriate viral inactivation method will consider the nature of the biotherapeutic product, as well as, the breadth of viruses which need to be effectively cleared. Generally, strict consideration needs to be given to alternative methods or practices which prevent extraneous viral contamination for vaccine types such as live-attenuated viruses — where the biotherapeutic product is a viral particle.

Specific methodologies for such products may include one or more nanofiltration or chromatographic processes for effective extraneous viral load reduction in the respective raw material sources. Inactivated or destroyed viruses may still undergo an appropriate low pH or solvent or detergent based viral inactivation process — as this may still maintain the desired immuno-stimulatory effect even if the viral product is denatured or otherwise disrupted.

Viral inactivation methods for oligonucleotide product or molecule types are not widely considered necessary.