| 1. |
- Abbot, Stewart, et al.
(författare)
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Report of the international conference on manufacturing and testing of pluripotent stem cells
- 2018
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Ingår i: Biologicals. - : Elsevier BV. - 1045-1056. ; 56, s. 67-83
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Sessions included an overview of past cell therapy (CT) conferences sponsored by the International Alliance for Biological Standardization (IABS). The sessions highlighted challenges in the field of human pluripotent stem cells (hPSCs) and also addressed specific points on manufacturing, bioanalytics and comparability, tumorigenicity testing, storage, and shipping. Panel discussions complemented the presentations. The conference concluded that a range of new standardization groups is emerging that could help the field, but ways must be found to ensure that these efforts are coordinated. In addition, there are opportunities for regulatory convergence starting with a gap analysis of existing guidelines to determine what might be missing and what issues might be creating divergence. More specific global regulatory guidance, preferably from WHO, would be welcome. IABS and the California Institute for Regenerative Medicine (CIRM) will explore with stakeholders the development of a practical and innovative road map to support early CT product (CTP) developers.
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| 2. |
- Arbesu Valdivia, Alejandro, et al.
(författare)
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Characterization of recombinant antibodies for cancer therapy by infrared spectroscopy
- 2013
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Ingår i: Biologicals (Print). - : Elsevier BV. - 1045-1056 .- 1095-8320. ; 41:2, s. 104-110
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Tidskriftsartikel (refereegranskat)abstract
- Fourier transform infrared (FTIR) spectroscopy was used to study the structure of the recombinant antibodies 1E10, anti-CD20 and hR3, which are used as anti-cancer therapeutic drugs. We tested their sensitivity against different conditions and treatments such as pH, temperature, freeze-thaw cycles and drying, which are relevant for the practical usefulness of the drugs. All antibodies were stable against moderate temperature increases (up to 50 degrees C) and pH changes (range 5-9). 1E10 was sensitive to extreme pH values (pH 3 and 12), whereas hR3 was most sensitive to temperature (at and above 60 degrees C). We did not observe any significant changes upon freeze-thaw and drying treatments. The secondary structure content of all three antibodies was estimated to be similar to that of IgG with similar to 64% beta-sheet, 0% alpha-helix and similar to 36% other structure. (C) 2012 The International Alliance for Biological Standardization.
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| 3. |
- Asper, M., et al.
(författare)
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Removal of xenotropic murine leukemia virus by nanocellulose based filter paper
- 2015
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Ingår i: Biologicals (Print). - : Elsevier BV. - 1045-1056 .- 1095-8320. ; 43:6, s. 452-456
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Tidskriftsartikel (refereegranskat)abstract
- The removal of xenotrpic murine leukemia virus (xMuLV) by size-exclusion filter paper composed of 100% naturally derived cellulose was validated. The filter paper was produced using cellulose nanofibers derived from Cladophora sp. algae. The filter paper was characterized using atomic force microscopy, scanning electron microscopy, helium pycnometry, and model tracer (100 nm latex beads and 50 nm gold nanoparticles) retention tests. Following the filtration of xMuLV spiked solutions, LRV >= 5.25 log(10) TCID50 was observed, as limited by the virus titre in the feed solution and sensitivity of the tissue infectivity test. The results of the validation study suggest that the nanocellulose filter paper is useful for removal of endogenous rodent retroviruses and retrovirus-like particles during the production of recombinant proteins.
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| 4. |
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| 5. |
- Chauhan, Shakti, et al.
(författare)
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Designing peptide-based vaccine candidates for Plasmodium falciparum erythrocyte binding antigen 175
- 2020
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Ingår i: Biologicals (Print). - : Elsevier. - 1045-1056 .- 1095-8320. ; 67, s. 42-48
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Tidskriftsartikel (refereegranskat)abstract
- Plasmodium falciparum leads to a virulent form of malaria. Progress has been achieved in understanding the mechanisms involved in the malarial infection, still there is no effective vaccine to prevent severe infection. An effective vaccine against malaria should be one which can induce immune responses against multiple epitopes in the context of predominantly occurring HLA alleles. In this study, an integrated approach was employed to identify promiscuous peptides of a well-defined sequence of erythrocyte binding antigen-175 and promiscuous peptides for HLA alleles were designed using bioinformatics tools. A peptide with 15 amino acids (ILAIAIYESRILKRK) was selected based on its high binding affinity score and synthesized. This promiscuous peptide was used as stimulating antigen in lymphoproliferative responses to evaluate the cellular immune response. It was observed this peptide evokes lymphoproliferative and cytokine responses in individuals naturally exposed to the malaria parasite. The intensity of PBMCs proliferation was observed to be higher in sera obtained from P. falciparum exposed as compared to unexposed healthy individuals, suggesting earlier recognition of peptide of this region by T cells. Furthermore, the binding mode of HLA–peptide complex and their interaction may lead to a rational and selective peptide-based vaccine candidate design approach which can be used as a malaria prophylaxis.
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| 6. |
- Manukyan, Levon, et al.
(författare)
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Virus removal filtration of chemically defined Chinese Hamster Ovary cells medium with nanocellulose-based size exclusion filter
- 2019
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Ingår i: Biologicals (Print). - : ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD. - 1045-1056 .- 1095-8320. ; 59, s. 62-67
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Tidskriftsartikel (refereegranskat)abstract
- Sterility of bioreactors in biotherapeutic processing remains a significant challenge. Virus removal size-exclusion filtration is a robust and highly efficient approach to remove viruses. This article investigates the virus removal capacity of nanocellulose-based filter for upstream bioprocessing of chemically defined Chinese hamster ovary (CHO) cells medium containing Pluronic F-68 (PowerCHO (TM), Lonza) and supplemented with insulin-transferrinselenium (ITS) at varying process parameters. Virus retention was assessed by spiking ITS-supplemented PowerCHO (TM) medium with small-size Phi X174 phage (28 nm) as a surrogate for mammalian parvoviruses. The nanocellulose-based size exclusion filter showed high virus retention capacity (over 4 log(10)) and high flow rates (around 180 L m(-2) h(-1)). The filter had no impact on ITS supplements during filtration. It was further shown that the filtered PowerCHO (TM) medium supported cell culture growth with no impact on cell viability, morphology, and confluence. The results of this work show new opportunities in developing cost-efficient virus removal filters for upstream bioprocessing.
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| 7. |
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| 8. |
- Eggers, Sonke, et al.
(författare)
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Predator-induced reductions in nest visitation rates are modified by forest cover and food availability
- 2008
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Ingår i: Behavioral Ecology. - : Oxford University Press (OUP). - 1045-2249 .- 1465-7279. ; 19:5, s. 1056-1062
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Tidskriftsartikel (refereegranskat)abstract
- Bird parents can alert predators to the location of their nest. One mitigating option is that parents reduce their nest visitation rate in exchange for a lower predation risk. Here, using field data and experiments, we show that Siberian jay Perisoreus infaustus parents adjust feeding visit rates depending on an interaction of 3 factors: predator activity, nest concealment, and food availability. The rate of nest visits increased with the degree of nest concealment; yet, this relationship was modified by the presence of corvid predators. As the vegetation became more dense, parents at sites with high corvid activity disproportionately increased their feeding visit rates when compared with birds at sites with low corvid activity. We experimentally assessed how nesting cover affects this response of parents to the presence of corvids by using an Eurasian jay Garrulus glandarius model. Parents nesting at open sites ceased nest visits, whereas those nesting in dense forest continued feeding, albeit at a lower rate. Cover may thus not fully compensate for the effect of predator activity on feeding visit rates. However, offspring exposed to high predator activity might still receive the same amount of food because parents may adjust load sizes to compensate. This idea was confirmed by an experiment showing that in areas of high predator activity, food-supplemented birds significantly decreased nest visits when compared with nonsupplemented birds. These results indicate that some bird species can employ multiple nest-defense strategies to reduce predator-attracting nest visits; yet, these strategies may carry fitness consequences through reduced offspring quality.
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