OP White Papers - random
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Achieving Rapid, High-Titer Expression For Next-Generation Biologics
3/5/2025
This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.
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Safety, Containment, And Analysis Of Highly Potent Compounds
5/16/2024
Explore a comprehensive overview of the challenges, requirements, and best practices for safely working with highly potent compounds in drug development and manufacturing.
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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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Accelerated Development Of Solid Oral Dosage Formulation For IND Submission
12/11/2024
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.
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Developing Effective Procedures
10/21/2024
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
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The Problem With Construction Quality
10/21/2024
Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.
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Compound Library Consortium
5/16/2024
Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.
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Analytical Techniques For Characterization, Release, And Stability Testing
4/28/2025
Review the analytical considerations for subunit vaccines, vaccines that contain only the antigenic component(s) of a pathogen, and more specifically the assays needed.
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Analytical Development Services
4/28/2025
Understand the basic principles of analytical development for cGMP assays and the assays that are generally relevant to major biopharmaceutical modalities.
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Solving The AAV Scalability Challenge
12/18/2024
Explore the effectiveness of a flexible, scalable AAV manufacturing platform that incorporates well-characterized bioreactors and advanced production systems to drive the development of cost-effective, high-quality gene therapies.