FEATURED EDITORIAL
This article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the Emergency Use Authorization (EUA), post-approval surveillance and monitoring, and more.
- Baxalta v. Genentech: The Latest Case In Patenting Functionally Claimed Antibodies
- In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist?
- New Developments In mRNA Vaccine Efficacy Show Promise
- Legal And IP Protection For New Biotechs
- An Overview Of FDA Efforts To Encourage DHT Use In Drug & Biological Product Development
- Key Considerations For Cell & Gene Therapy Developers To Tap Into AI
- Opportunities For AI To Assist Cell & Gene Therapy Companies
FEATURED APPLICATION CONTENT
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Explore the challenges faced by a large CDMO as well as the solutions that were provided to achieve significant time savings, cost savings, and the removal of a major downstream process limitation.
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See how enhanced T cell expansion as well as the generation of an early-differentiated phenotype can be achieved using a cell culture medium for T cells and cytokines, in a static bioreactor system.
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Explore how valuable insights into the status of cells in culture from the analysis of spent media can support more productive processing as well as medium formulation or culture parameter optimization.
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Here, we demonstrate a rapid method for the separation of empty and full AAV8 particles by linear gradient elution on CIMmultus® QA monoliths with 80% recovery.
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We demonstrate how a mAb purification batch process can be converted into a stepwise intensified batch process, successfully eliminating intermediate steps and achieving more than 13% cost reductions.
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This study explores the feasibility of using single-use chromatography membrane technology as an alternative to resin-based chromatography in an ADC process.
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Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor (TKI) drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.
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Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.
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To meet large-scale production challenges, a modular platform-based approach was developed to offer a simplified, standardized design for protein- and virus-based therapy production processes.
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Review the capabilities and robustness of a new single-use fermenter in a fast, exponentially growing, high cell density Escherichia coli (E. coli) process.
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Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.
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Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.
FEATURED NEWS HEADLINES
- Queen’s And Almac Discovery Launch State-Of-The-Art Chemoproteomics Facility In Belfast
- Montefiore Einstein Comprehensive Cancer Center Awarded FDA Grant For Clinical Trial On Experimental AML/MDS Treatment
- Carisma Therapeutics Announces FDA Clearance Of IND Application For CT-0525, A Novel HER2-Targeting CAR-Monocyte
- Scientists Harness Flower ‘Super Power’ To Pave The Way For New Drug Treatments
- Orexo Announces FDA Acceptance Of New Drug Application Filing For OX124, A High-Dose Rescue Medication For Opioid Overdose
- Evommune And Accutar Biotechnology Announce AI Drug Discovery Collaboration
- PRISM BioLab And Lilly Enter Into A Drug Discovery Collaboration On A Protein-Protein Interaction Target
- Renewed Partnership To Boost The Skills Needed To Drive Drug Discovery And Development In Africa
- Arcturus Therapeutics Receives Orphan Drug Designation From The U.S. FDA For ARCT-032, For The Treatment Of Cystic Fibrosis
- Artificial Intelligence Finds Ways To Develop New Drugs
ARCHIVED NEWSLETTER
- 11.28.23 -- FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology
- 11.21.23 -- Respiratory Viral Infections: The Next Frontier For Antiviral Drug Development
- 11.20.23 -- Increasing Oral Bioavailability And Solubility: Solid Form Strategies
- 11.15.23 -- Spray Drying Technology Developments For Challenging Combination Formulations
- 11.14.23 -- Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture