Search results for " therapeutic" in Articles / App Notes
Article
Epitope Binning: A Critical Step in Antibody Selection
Read about how surface plasmon resonance (SPR) is used to characterize closely related “bins” of monoclonal antibodies (mAbs) targeting the same epitope of the target protein, and how the selection …
Article
Mapping a Route for Cell and Gene Therapy Process Development
The ability to generate and manufacture well-characterized batches of cells for therapeutic use requires significantly different approaches to typically implemented laboratory-based cell-culture techn…
Article
Driving Improved Access to Biosimilars
FDA, Draft Guidance for Industry: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Related Assessments (Rockville, MD, May, 2019).
13. Z. Brenn…
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Methods Accelerate Biosimilar Analysis
FDA, Draft Guidance to Industry; Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (Rockville, MD, May 2019).
2. R. S Rog…
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Getting it Right from the Start in the Drug Development Process
As a result, the desired therapeutic outcome is achieved without compromising patient safety or introducing dangerous side effects.
Both upstream processing and downstream processing can affec…
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Case Study: Oncolytic Adenovirus Production
Oncolytic viruses constitute a promising therapeutic approach for treatment of cancer. These viruses selectively replicate in tumor cells and effectively kill these cells without harming normal cell…
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
“Biomanufacturing is going through an unprecedented period of innovation in new products and growth in legacy therapeutics that promise many new jobs over the next decade and beyond,” JIB executive di…
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Are You in Control of the Quality of Your mAbs?
…technology has been adopted to develop and qualify assays for monoclonal antibodies (mAbs) and other therapeutic proteins to ensure drug quality.
Sign up to view an on-demand recording and receiv…
Article
Biomanufacturing: The Cost of Unskilled Workers
First, a 2018 report from BioPlan Associates estimates there are well over 10,000 therapeutics in R&D, both drugs (chemical substance pharmaceuticals) and biopharmaceuticals (biotechnology-derived pha…
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Ensure SEC Column Reproducibility in Protein Drug Analysis
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you…