Search results for " formulation" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
For example, changes in formulations may cause different leachable profiles requiring increasing emphasis on extractables/leachables techniques (i.e., high-resolution MS) to support characterization o…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Climate Change in Outsourcing
…commercial-scale CMOs are investing in their development capabilities to satisfy post-POC demand for formulation and manufacture of Phase III and commercial requirements.
The differing requiremen…
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QbD and PAT in Upstream and Downstream Processing
One of the key parameters to monitor in the implementation of QbD in mAb production is the glycosylation process during formulation. Glycosylation is one of the overriding contributors to mAb heteroge…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
He also notes that adherent expression systems generally rely on serum-containing media formulations, and animal-derived components pose an additional risk for the introduction of adventitious agents …
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Assessing Manufacturing Process Robustness
In manufacturing, this relates to attributes attributes of material, formulation, and associated processing parameters including scale-up factors, processing equipment, test method, personnel, and fac…
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Good Manufacturing Practices: Challenges with Compliance
The amount of complex formulation work involved in biologic products is highly challenging. There is an underlying assumption in regulations that most biologics are destined for simple filtration and …
Article
Advances in Engineering of Protein-Based APIs
This advance can be seen in drug candidates based on constrained peptides, such as those from Protagonist Therapeutics, and in the formulation design of an oral GLP-1 agonist from Novo Nordisk,” he sa…
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Understanding Validation and Technical Transfer, Part I
The clinical formulations must be scalable to commercial production, retaining their effectiveness and safety attributes. Commercial production processes must be robust and reliable to ensure consiste…
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Impact of Media Components on CQAs of Monoclonal Antibodies
The formulation of optimal culture media for propagation of cultured mammalian cells has received a lot of interest for many years as a result of its critical impact on the animal cell technology base…