OP White Papers - random
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Advanced Methodology Of PLGA-Based Parenteral Formulations
5/7/2025
To enable the development of optimized PLGA-based sustained release formulations, this paper offers essential insights into the polymer’s properties, fabrication techniques, and drug release mechanisms.
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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.
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Liposomal And Nanoparticle Technology
9/3/2025
Specializing in oncology, anti-infective, and complex formulations, Pfizer Melbourne provides manufacturing services for sterile dosage forms.
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Preclinical Evaluation Of Vaccines And Antivirals In RSV Challenge SCID Mouse Models
6/10/2025
Advance your RSV therapeutic pipeline with trusted, IND-enabling preclinical services that deliver clinically relevant data through optimized study designs and validated rodent models.
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Enabling Digital Twins With Computational Fluid Dynamics Modeling
1/16/2025
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
8/15/2024
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
6/12/2025
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
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Protein Stress Testing
4/28/2025
Start your forced degradation studies early to uncover molecular risks, strengthen product stability, and ensure regulatory-ready development from the start.
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Revolutionizing Particle Characterization With Image Analysis And ML
9/27/2023
The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.
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Compliance With Annex 1- Sterile Fill Finish
5/5/2025
Eurofins ensures Annex 1 compliance through robotic isolators, PUPSIT, contamination control strategies, and rigorous training for aseptic sterile fill-finish of early-phase clinical products.