Search results for " industry" in Articles / App Notes
Article
Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
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Methods Accelerate Biosimilar Analysis
Conclusion
The biosimilar industry in the United States has been evolving more slowly than anticipated and drug competition that would have resulted in lower costs for biologics has yet be realize…
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Tools and Processes for Mature and Emerging Therapies
…requirements for emerging cell therapies and gene therapies may require revolutionary changes to the industry’s approach to making drugs.
In April 2019, at the INTERPHEX trade show in New York Ci…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
The biopharmaceutical industry faces an increasing demand to accelerate process development while saving on cost and time. A possible solution to alleviate this is by using high-throughput potential t…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
Clearly, industry members (including Process Development Forum readers) are extremely interested in learning about what these solutions have to offer, but the adoption of single-use systems is still c…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
New problems, new solutions
An ongoing pharmaceutical industry trend has been the adoption of faster and more sensitive glycoanalytical workflows. Over the past few years, several commercial suppl…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
Clinical development is crucial, but industry needs to have “manufacturing under control,” Marks observed.
More support
FDA’s Regenerative Medicine Advanced Therapy (RMAT) program can help exp…
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Challenges in Cell Harvesting Prompt Enhancements
The past decade has seen the biopharmaceutical industry move toward significantly higher titers, and, as a result, higher cell densities. Biomanufacturers have been shifting from large stainless-steel…
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Miniaturization to Become Even More Successful
The industry has turned to high-throughput process development (HTPD) methods—miniaturization, parallelization and automation in particular—to carry out the large number of experiments required for th…
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Automation Trend in Fill/Finish Reduces Contamination Risk
Handling sterile liquids in the pharmaceutical industry has traditionally relied on consistent techniques over the past 100 years, and changes in technology and regulations have been relatively slow, …