Search results for " formulation"
Article
Downstream Processing for Cell-Based Therapies
… expansion stage and, depending on the therapy, can include harvesting, washing, cell concentration, formulation, final fill/finish, and preservation.
Despite the fact that most CGT manufacturing…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
This test compares the spectrum of each media with the spectrum of each corresponding control and was successfully employed for identification of different types of growth media with diverse formulati…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Since then, HTPD in chromatography applications has been well established among most biopharmaceutical companies, but has also expanded to upstream and cell culture screening as well as to formulation…
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Improving Process-Scale Chromatography
Second, because buffers are multi-component formulations, the common ion effect (CIE) limits the concentration grade when preparing stock solutions. In addition, the subsequent dilution may cause pH a…
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Setting Standards for Biotech Therapeutics in India
Similarly, IP 2007 contained 271 new monographs with focus on those drugs and formulations that cover the National Healthcare Programs and the National List of Essential Medicines. The addendum in 200…
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High-concentration monoclonal antibody drugs: manufacturing challenges
Manufacturing unit operations that are directly impacted by higher concentration formulations range from ultrafiltration to sterile filtration, filling, mixing and storage. Solutions that maintain qua…
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Evolving demands of process development services
Integrated models provide much greater flexibility and enable API and formulation teams to work side by side.
Phase-appropriate development is also often asked of many CDMOs, and this usuall…
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Reimagining Affordable Biosimilars
Nano differential scanning fluorimetry (nano-DSF) has emerged as a high throughput platform for screening biotherapeutic formulations. Light scattering tools permit label-free size characterization, t…
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Using Multiple Techniques in Biosimilar Analysis
Each molecule and/or formulation system can present unique obstacles. For example, the sequence of the molecule may preclude certain techniques, or make other techniques difficult because of the size …
Article
Preclinical Evaluation of Product Related Impurities and Variants
This may be attributed to the complexities related to the use of cell lines, media formulation, and other bioprocessing steps that are prone to variability to varying degrees (4).
The inherent …