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Critical Factors for Fill–Finish Manufacturing of Biologics
In perspective: aspirin (upper left, front), somatropin (middle molecule), and an antibody (lower right, back) — to approximate scale — molecular models from Wikicommons Over recent decades,...
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Ask the Expert Liposome and Viral Vector Characterization: Use of Electron...
with Dr. Josefina Nilsson For this webcast, Josefina Nilsson (EM Services business unit head) discussed Vironova’s work, including case studies. She focused on characterization of drug and gene...
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Osmolality Measurements for High-Concentration Protein–Polymer Solutions:...
BRISTOL-MYERS SQUIBB (WWW.BMS.COM) Osmolality is a critical attribute for injectable formulations. It is desirable to have products match physiological osmotic conditions. Furthermore, osmolality...
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Investigation of Foreign-Particle Contamination: Practical Application of...
Figure 1: Absorbance Fourier-transform infrared (FT-IR) spectra of different test articles made of polypropylene The presence of visible foreign particulate matter is considered a critical defect in...
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Aggregation from Shear Stress and Surface Interaction: Molecule-Specific or...
WWW.PHOTOS.COM Exposure to solid–liquid and air–water interfaces during production, freezing and thawing, shipment and storage of protein therapeutics may be a contributing factor in their degradation...
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Development of a Freeze-Dried Ebola-Expressing Adenoviral Vector: Unexpected...
Replication-defective (E1 gene-deleted) chimpanzee type-3 adenovirus (ChAd3) (HTTPS://MICROBEWIKI.KENYON.EDU/INDEX.PHP/ ADENOVIRUS-BASED_GENE_THERAPY:_A_PROMISING_ NOVEL_CANCER_THERAPY) In December...
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Apparent Matrix Effects in an Iduronate 2-Sulfatase Specific Activity Assay
Figure 1: Reactions in the SHP631 I2S activity assay: In the first step catalyzed by I2S, the substrate (IdoA2S-4MU) is hydrolyzed to IdoA-4MU and sulfate. In the second step, 4MU is released by the...
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Analytical Strategies for Fixed-Dose Coformulated Protein Therapeutics
Figure 1: Comparing considerations for analytical development of coformulated products with those of coadministered products Coformulation of two or more proteins in a single formulation is an emerging...
View ArticleBiopharmaceutical Product Specification Limits and Autocorrelated Data
Calculations, including statistical tolerance intervals, can assist in the development and revision of specification acceptance criteria. Manufacturing results for attributes of a biopharmaceutical...
View ArticleStability Testing: Monitoring Biological Product Quality Over Time
Many physical and chemical factors can affect the quality, safety, and efficacy of biopharmaceutical products, particularly after long-term storage in a container–closure system that can be subject to...
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