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Get the Right Lipid Nanoparticle Formulation Ensuring Effective Drug Delivery

September 13, 2023

Critical Quality Attributes Biologics Biologics are a class of pharmaceutical products derived from living organisms, including proteins, nucleic acids, and cells, which are used to treat various diseases. These therapeutic agents possess critical quality attributes that are essential for their safety and efficacy. These attributes include structural integrity, purity, potency, and stability. Structural integrity ensures that the biologic maintains its three-dimensional conformation necessary for its biological activity. Purity refers to the absence of impurities, such as other proteins or contaminants, which may affect the product's safety or function. Potency represents the biological activity of the biologic, indicating its ability to exert the desired therapeutic effect. Stability is crucial to maintain the product's efficacy over time, as any degradation or loss of activity can compromise its clinical utility. The characterization and control of these critical quality attributes are essential throughout the development, manufacturing, and regulatory processes to ensure the consistent and reliable performance of biologics.

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Blog LNP formulation hero image 750x250 1

Get the Right Lipid Nanoparticle Formulation Ensuring Effective Drug Delivery

September 13, 2023

Critical Quality Attributes Biologics Biologics are a class of pharmaceutical products derived from living organisms, including proteins, nucleic acids, and cells, which are used to treat various diseases. These therapeutic agents possess critical quality attributes that are essential for their safety and efficacy. These attributes include structural integrity, purity, potency, and stability. Structural integrity ensures that the biologic maintains its three-dimensional conformation necessary for its biological activity. Purity refers to the absence of impurities, such as other proteins or contaminants, which may affect the product's safety or function. Potency represents the biological activity of the biologic, indicating its ability to exert the desired therapeutic effect. Stability is crucial to maintain the product's efficacy over time, as any degradation or loss of activity can compromise its clinical utility. The characterization and control of these critical quality attributes are essential throughout the development, manufacturing, and regulatory processes to ensure the consistent and reliable performance of biologics.

Identifying Critical Quality Attributes in Drug Products: Your Key to Ensuring Safe and Effective Therapeutics

August 30, 2023

Schematic of experimental set-up. (A) A 50 µm I.D. glass capillary in a microtensiometer set-up is used to flow air into sample solution during microbubble aeration. (B) Following the applied stress, the entire sample is transferred to the membrane well plate for BMI using a pipette. (C) Vacuum is applied to the bottom of the membrane plate and sample is pulled through the membrane, leaving particles over 2 µm diameter deposited on the membrane for measurement using BMI from publication reference: Wood, C. V., Razinkov, V. I., Qi, W., Furst, E. M., & Roberts, C. J. (2021). A Rapid, Small-Volume Approach to Evaluate Protein Aggregation at Air-Water Interfaces. Journal of pharmaceutical sciences, 110(3), 1083–1092. https://doi.org/10.1016/j.xphs.2020.11.024

Advanced Prediction for Protein Aggregation Based on Air-Water Interfaces

August 23, 2023

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How Aura PTx is Empowering Biologics Developers to Work More Efficiently

August 17, 2023

A comparison of background membrane imaging versus flow technologies for subvisible particle analysis of biologics

Under the Microscope: Better Subvisible Particle Analysis Methods for Biologics

August 2, 2023

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Perform Low Volume Particle Analysis with a Strong Statistical Foundation

July 19, 2023

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Reinventing Membrane Imaging with BMI: A Better Way to Perform Particle Analysis

July 12, 2023

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Breaking the Bias: Women Leadership in Biotech

June 28, 2023

particle analysis

Light Obscuration May Not Be Enough to Detect SVPS in Your Drug Product

June 15, 2023

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