Search results for " start"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ous adventitious contaminants at appropriate stages of the manufacturing process from raw materials, starting materials (e.g., cell banks, viral and bacterial seeds), and manufacturing intermediates;…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Whether it is just-in-time preparation, one day in advance of use, or before any purification is started, will influence how much space is required for buffer storage or whether a system of built-in p…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Late-phase development starts from the manufacture of product for the first registration dose (FRD) using commercial manufacturing processes and ends with process validation and submission of the prod…
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GMP Challenges for Advanced Therapy Medicinal Products
In particular, they often do not have adequate systems in place for evaluating the quality of starting and raw materials, which is a vital necessity in the production of advanced, usually biological, …
Article
Fluid Handling in Biopharma Facilities
Fluid Handling Capabilities
BioPharm: What is the best way to determine which fluid handling capabilities are needed within a facility?
Butler (AdvantaPure): A good start is to overlay your proc…
Article
Modular Manufacturing Platforms for Biologics
While the idea of modular construction has been used in other industries for decades, it has only started gaining traction for pharmaceutical applications during the past 20–30 years.
Modular syst…
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Continuous Chromatography: Trends, Definitions and Approaches
Please remember that in PCC operation, when the first column in the loading zone reaches a desired saturation level and/or the second column starts to show product breakthrough, there must be a new co…
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Drug Discovery and Development in India
Ang says, “The move of Indian start-ups into the drug discovery space will present a new source of innovative medicines to the Indian pharmaceutical sector. However, we expect their impact to come pri…
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Continuous Manufacturing: A Changing Processing Paradigm
“In a batch system there are many non-productive days associated with startup and turnaround between batches.”
Even though continuous manufacturing/perfusion has been around since the 1980s–first …
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The inoculum was centrifuged at 400 × g for five minutes, after which the supernatant was discarded and the cell pellet suspended in 37 °C prewarmed test and control media to start cell concentration …