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Downstream Processing
Published in Sarfaraz K. Niazi, Disposable Bioprocessing Systems, 2016
Planova filters (www.planovafilters) are the world’s first filters designed specifically for virus removal. The first Planova filter was launched in 1989 by the Asahi Kasei Corporation, one of the world’s leading filter manufacturers. Planova filters significantly enhance virus safety in biotherapeutic drug products such as biopharmaceuticals and plasma derivatives. They exhibit unparalleled performance in clearing viruses, ranging from human immunodeficiency virus (HIV) to parvovirus B19, while providing maximum protein recovery. Planova filters contain a bundle of straw-like hollow fibers. When a protein solution with possible viral contamination is introduced into these hollow fibers, the solution penetrates the fiber wall and works its way to the outside of the fiber.
Cellular Therapeutics: A Novel Modality with Great Therapeutic Potential
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
For allogeneic products, guidance documents exist that dictate the type of testing that should be performed on the establishment of a bank (4). If only a single cell bank is being used, testing should be complete on this MCB before the product derived from it is used in human clinical trials. Stability should also be performed on the MCB but since there are no accelerated stability studies for cell therapy products, stability can be going concurrently with usage. Testing that should be part of the characterization panel is as follows: ViabilitySterility (USP<71>, EP2.6.27)Mycoplasma (USP<63>, EP2.6.7)Endotoxin (USP<85>, EP2.6.14)IdentityPurityKaryologyTumorigenicityHIV (human immunodeficiency virus) 1&2HTLV (human T-cell lymphotropic virus) 1&2HBV (hepatitis B virus)HCV (hepatitis C virus)SyphilisAdventitious agent assayCFR bovine adventitious agents (if bovine materials are used)CFR porcine adventitious agents (if porcine materials are used)SV40 DNA sequencesParvovirus B19Potency.
Crispr biosensing and Ai driven tools for detection and prediction of Covid-19
Published in Journal of Experimental & Theoretical Artificial Intelligence, 2023
Abdullahi Umar Ibrahim, Pwadubashiyi Coston Pwavodi, Mehmet Ozsoz, Fadi Al-Turjman, Tirah Galaya, Joy Johnson Agbo
Scientists have explored the mechanism behind the CRISPR/Cas system to develop molecular diagnostic assay for detection of infectious diseases through detection of genes associated with Duchene muscular dystrophy, Zika viruses, dengue viruses, Mycobacterium tuberculosis 165 rRNA, DNA & RNAs of Scrub typus (ST) and severe fever thrombocytopenia syndrome (SFTS), human papillomavirus 16 (HPV-16) and Parvovirus B19 (PB-19), MicroRNAs in blood sample of children with brain cancer etc. CRISPR-based biosensors can be classified based on cleavage or binding and also based on Cas effectors using Cas9 and dCas9, Cas12 and Cas13 (Li et al., 2019). In this survey, we concentrated on CRISPR-based biosensors used for detection of viruses irrespective of Cas effectors or binding and cleavage mechanisms.