Search results for " Asia" in Articles / App Notes
Article
Bracing for a Future Wave of Advanced Therapies
Rich development pipeline
ARM’s industry evaluation shows that, across North America, Europe, and Asia Pacific in 2023, the field of CGTs saw more than 2500 developers throw their hat into the rin…
Article
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
The April announcement focused on the Asia Pacific and Australian regions, but the collaboration’s benefits are already available to users in North America and Europe, says Waters.
Tive offers non…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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Article
Patenting Prospects for Cell-Based Therapies
Half of such trials are in the US with another one-quarter in Asia (1). About one-third of these trials include mesenchymal stem cells; 17% utilize hematopoietic cells, and only 5% involve embryonic s…
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Evaluating E&L Studies for Single-Use Systems
McGohan, BioPharma Asia 5 (4), 6-11 (2016).
2. FDA, Code of Federal Regulations 21 Part 211.65 and §211.94.
3. BPOG, Standard Extractables Protocol for Biopharmaceutical Single Use Sys…
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Drug Quality Key to Innovation and Access
…g shipments, they will face multiple tracking and serialization systems under development in Europe, Asia, and South America. The lack of harmonization in these efforts reflects continued challenges …
Article
Platform Approach Speeds Process Development
Figure 3 illustrates how the use of identical disposable equipment, and thus the same process flow, resulted in comparable the cell-culture performance between processes performed in Europa and Asia. …
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Innovative Therapies Require Modern Manufacturing Systems
The organization now seeks more involvement of regulatory authorities and manufacturers in Asia, Africa, and the Americas in the ICH standards-setting process. FDA, the European Medicines Agency, and …
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Taking a “Development-by-Design” Approach to Cell Therapies
Invetech has been working on cell therapy process scale-up automation for more than 10 years and has successfully completed projects in North America, Europe, and Asia for companies that include Argos…
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Biomanufacturing Outsourcing Globalization Continues
Top outsourcing destinations
Offshoring for biologics has been generally equated with emerging hubs in Asia, especially Singapore, China, India, or Korea. This trend is changing, as domestic CMOs …