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Nonclinical Studies for Biosimilars
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
Karen De Smet, Leon AGJM van Aerts
Pharmacopoeial bioassays with potency determination in animals exist for some biologicals. Such assays are employed to express the biological activity of the product in international units (IUs). However, there may be considerable variability in these in vivo assays, which limits their use in a comparability exercise (Mulders et al., 1999; Zimmermann et al., 2011). Therefore, the results are not expected to contribute significantly to establishing biosimilarity.
Enzymatic hydrolysis of barley straw for biofuel industry using a novel strain of Trametes villosa from Paranaense rainforest
Published in Preparative Biochemistry & Biotechnology, 2020
Romina O. Coniglio, Gabriela V. Díaz, María I. Fonseca, María L. Castrillo, Florencia E. Piccinni, Laura L. Villalba, Eleonora Campos, Pedro D. Zapata
Enzymatic activity of the cell-free supernatant was determined as reducing sugars released from beechwood xylan or cellulose [Phosphoric Acid Swollen Cellulose (PASC), Avicel, and Carboxy Methyl Cellulose (CMC)]. Reducing sugars released were determined by dinitrosalicylic acid (DNS) assay[41] using glucose or xylose standard curves, based on the substrate (cellulose or xylan, respectively). In short, reactions were carried out in a final volume of 1 mL, with the appropriate dilution of cell-free culture supernatant, 0.5% xylan, Avicel or PASC, or 1% CMC, in 0.05 M acetate buffer (pH 4.8) and incubated 1 h at 50 °C and 300 rpm. 100 μL of each supernatant was transferred to a new tube and 200 μL of DNS was added, incubated for 5 min at 100 °C and incubated 10 min on ice. 200 μL were transferred to a microplate and absorbance was measured at 540 nm. Control reactions without enzymatic extract and without substrate were performed. One international unit (IU) was defined as the amount of enzyme that released 1 µmol of product per minute under the assay conditions.