Camargo
MAY 2, 2021
CMC: Innovative technologies, product manufacturing, reagents, starting materials, critical product components, novel delivery device qualification, and complex software issues. A sponsor must provide concise detail in the meeting package and ask specific , targeted questions so that the FDA can provide meaningful guidance.
Drug Discovery World
JANUARY 10, 2023
Our catalog of over 6,500+ primary antibodies, 1,200+ secondary antibodies, and 50+ ELISA kits includes reagents for multiplex IF, flow cytometry, and more in fields including immunology, oncology, and neuroscience.
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Drug Discovery World
MAY 7, 2024
The goal of these approaches is to improve process economics by eliminating steps and the amount of reagents, water and buffer. There have been numerous studies that have documented the ability to reduce time and labor, along with reagents and consumables, with single-use technologies compared to its counterpart.
pharmaphorum
JUNE 1, 2021
Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients.
Pharmaceutical Technology
FEBRUARY 3, 2023
“For each production process, you have to generate the plasmids in huge quantities with GMP quality and then do a transient transfection, meaning you mix them with a transfection reagent and add that to the cells in a very controlled way,” explains Faust. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. 1] BioNews.
The Pharma Data
OCTOBER 19, 2020
DB ( Becton, Dickinson and Company ) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. It allows the test to be used for people without any symptoms or suspicion of COVID-19, supporting widespread population testing.
The Pharma Data
JANUARY 22, 2021
The Biden team said it had identified 12 “immediate supply shortfalls” that have been critical to the pandemic response, including N95 surgical masks and isolation gowns, as well as swabs, reagents and pipettes used in testing, the Times reported. But the president, who has proposed a $1.9
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