Search results for " production" in Articles / App Notes
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Such advances, though, require further clarification of regulatory policies governing gene therapy production and quality assurance.
FDA is considering at least three CAR-T applications, and mo…
Article
Vaccine Development Faces Urgency and Challenges
Public and private funding for vaccine development and production has grown noticeably, from $822 million in 2000 to $3.6 billion in 2014, spurred by the “Decade of Vaccines” (2011-2020) initiative la…
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Application of Quality by Design to Viral Safety
QbD in the Viral Safety of Raw Materials
A wide variety of biological raw materials can be used in a biopharmaceutical process, ranging from production cells to buffer components to excipients. Th…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
To accommodate an expanding pipeline, the scale of clinical manufacture was increased to 1,200 L, enabling the production of sufficient supplies in a shorter campaign. This increase in scale made it n…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Article
Putting Viral Clearance Capabilities to the Test
Viral clearance studies assess the capability of a downstream process to remove or inactivate potential contaminants and are based on a scale-down model of a biopharmaceutical production process. The …
Article
Transformative Medicines Challenge FDA and Manufacturers
The company also may find it appropriate to tighten specification limits and may explore room temperature storage possibilities and a continuous manufacturing system for future production.
The…
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Platform Technologies Improve Protein Expression
In addition to exploring novel production methods such as continuous processes and disposable production technology, manufacturers also heavily invest in platform technologies for protein expression t…
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Bioburden Control in the Biopharmaceutical Industry
Establishing Microbiological Control Measures
The biopharmaceutical production line is subject to contamination from two main sources: firstly, operational endogenous organisms that are prod…