Search results for "analytical"
Article
Automating Bioprocesses
In addition, good process analytical technology (PAT) and ‘soft sensors’ (i.e., predicting values based on modeling) are important to ensure product quality. It is important to understand how disturba…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Due to limitations in the analytical capability of the SEC method used, and the relatively low aggregate level, it was not possible to quantitatively assign the percent of dimer versus higher-order mu…
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Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
The Tide Stays High
…, especially in those services that cater to clinical development (clinical supplies manufacturing, analytical services, clinical packaging, and clinical research). Many CDMOs have told PharmSource t…
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Managing Risk in Raw Material Sourcing
…g changes to manufacturing processes, raw materials, product specifications, product transfers, and analytical testing, be managed and approved in a structured, cross-functional way,” he says.
To…
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Advancing Single-Use Technology Through Collaboration
…at answers common questions suppliers might have about the scope, study design, sample preparation, analytical methods, and reporting involved in extractables testing. “To me, a key reason some manuf…
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Efforts Accelerate to Streamline Postapproval Change Process
…ed to increase batch size, shift to a new manufacturing facility, or improve process robustness and analytical methods.
Expanded global sourcing and sales complicates lifecycle product management…
Article
Perfusion in the 21st Century
Notably, because of the sophistication and efficacy of the controls used for all aspects of perfusion processes, such as pumps with feedback control or advanced in-line and on-line analytical tools, i…
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A Q&A with Eric Langer: CMOs Embrace New Technology
In comparison, biopharmaceutical innovators sought improved analytical assays and development, control systems, fill-finish services, and downstream PD services.
Why are CMOs early adopters?
…
Article
Managing Biomanufacturing Capacity Expectations
Analytical testing concerns and adequate hiring of qualified personnel to manage the facilities are among the other top issues that are expected to create capacity limitations in the future (Figure 2)…