OP White Papers - random
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Nasal Vaccine Development, Manufacturing, And Device Selection
7/11/2023
When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.
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Preclinical Immuno-Oncology Models For CAR T-Cell Therapy Development
5/21/2025
The following preclinical IND-enabling oncology studies conducted by scientists at Aragen over the past 10 years highlight the role of robust preclinical models in advancing the fight against cancer.
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Phase-Appropriate Approaches To Manufacturing And Testing
3/14/2025
Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
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Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity
2/14/2025
A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.
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Innovation In Filtration
3/18/2025
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
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Process Analytical Technology In The ADC Bioconjugation Process
4/23/2025
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
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Quality By Design (QbD) For Biologics From A CDMO Perspective
2/18/2025
Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.
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Leading European CDMO For Drug Product Manufacturing
6/2/2025
As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.
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Modern Modeling Tools For Small Molecule Solid Dose Manufacturing
3/10/2025
Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.
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Transitioning Your Product From Phase 1 To Phase 2 Clinical Studies
12/13/2024
Strategic partnerships can streamline your transition from Phase 1 to Phase 2 clinical studies, ensuring optimized dosage forms, seamless scale-up, and alignment with patient and study requirements.