Search results for " platform"
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Biopharma Seeks Balance
…, next-generation sequencing, continuous manufacturing for downstream processes, and a manufacturing platform for continuous bioprocesses (2).
New challenges to manufacturing
Manufac…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
As discussed in the current annual report, companies prefer to concentrate on one or a few platforms to be applied to as many products as possible. Most have or are moving to adopt mammalian systems a…
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Making the Move to Continuous Chromatography
For current commercial processes, however, many continuous chromatography platforms have software that aids in converting a batch process to a continuous process,” he comments.
Protein A captur…
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Modern Manufacturing Key to More Effective Vaccines
He noted that continuous manufacturing platforms can help ramp up vaccine supply on short notice and that FDA clarification of its requirements and standards should encourage industry investment in ne…
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FDA Framework Spurs Advanced Therapies
Need for new manufacturing technology
Indeed, developers of new regenerative medicines will require robust platform processes, such as automation technologies and 3-D bioreactors, to maintain cons…
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Preclinical Evaluation of Product Related Impurities and Variants
The platform should be capable of resolving all the product related species so as to allow the collection of a pool that is enriched in a particular species of interest. Multimodal chromatography has …
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Process Chromatography: Continuous Optimization
…ording to David Westman, global product marketing manager for Cytiva, are typically purified using a platform approach in which protein A chromatography resins are used in the first capture step. Pol…
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Managing Residual Impurities During Downstream Processing
He adds that the use of commercial or platform assays early in development is common, but most regulators expect a well-qualified process-specific or platform assay for later development and post-appr…
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Single-use Bioreactors Have Reached the Big Time
Many suppliers, including Cytiva, Sartorius, Pall, and Thermo Fisher Scientific, have developed new film platforms. Cytiva’s technology resulted from a strategic alliance with Sealed Air. Film validat…
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Process Chromatography Selection for Downstream Processing Applications
Protein A enables a platform process for mAbs thus enabling higher throughput of projects through process development and manufacturing.
BioPharm: What are some common chromatography column issues…