Search results for " drug"
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Trends in BioPharma Approvals in 2013
This drug is Herceptin to which a small cytotoxic molecule (DM1) has been conjugated, and like Herceptin, it is approved for the treatment of HER2-positive metastatic breast cancer. As in the case of …
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Early Communication with Regulators is Essential for SMEs
The importance of early dialogue with regulators
Companies are encouraged to contact the agencies as early as possible during the drug-development stage to ensure that their manufacturing proces…
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Implementing QbD in Sterile Manufacturing
… aseptic processing?
Weikmann: The potential critical quality attributes of a customer’s drug product in terms of aseptic processing are determined by the nature of the product and by the d…
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Operational Excellence: More Than Just Process Improvement
FDA Commissioner Margaret Hamburg told participants at the Annual Meeting of the Generic Pharmaceutical Manufacturers Association that the agency will increasingly focus on GMPs to improve drug qualit…
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Navigating Emerging Markets: Middle East and North Africa
Jordan does serve as a major manufacturer of pharmaceuticals, exporting the majority of its drugs to other Arab countries (9).
Overall, according to the Central Intelligence Agency’s (CIA) Worl…
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Exosome isolation by tangential flow filtration and size exclusion chromatography
We demonstrate a scalable workflow for the isolation of exosomes—a type of extracellular vesicle with significant potential for targeted drug/gene delivery. For research and development and di…
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Bracing for a Future Wave of Advanced Therapies
HHS Secretary Responds to the President’s Executive Order on Drug Prices. Press Release, Feb. 14, 2023.
12. FDA. Establishment of the Office of Therapeutic Products. fda.gov (accessed Jan. 11, 2…
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Boosting biopharma resilience: The need to shift focus and increase collaboration
Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength an…
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Discussing the Origins of the mRNA Therapeutics Field
Andy Geall, co-founder and chief development officer at Replicate Bioscience, discusses the historical context and buildup of the mRNA therapeutics field.
Watch video
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How can you harness the potential of nucleic acid therapeutics?
At Cytiva, the new team is here to support you. We can help you throughout the
development of your manufacturing workflow for oligonucleotides
and the purification of mRNA drug subs…