OP White Papers - random
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Streamlining And Standardizing Cell And Gene Therapies From Process To Product
1/13/2023
Cell and gene therapies are transforming the lives of patients with various rare genetic diseases and more common conditions such as cancer. However, the rapid pace of scientific progress has overwhelmed supply infrastructure, creating pressures to scale manufacturing, increase capacity and meet a wide range of deliverable requirements.
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Optimization Of Hydrogen Peroxide Decontamination
6/6/2022
Understanding critical influencing factors of hydrogen peroxide bio-decontamination is key for reliable process parameters.
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Using Next Generation Sequencing Methods For Virus Vector Identity Testing
9/7/2022
Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Learn what advantages NGS offers for obtaining accurate sequences.
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Pharma Research, Development, & Launches Save Lives — & The Earth
6/1/2023
Understand how a defined framework and way of measuring allows companies to align priorities, short- or long-term goals, and what ESG success looks like.
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β-Glucan As A Process-Related Impurity In Biopharmaceuticals
5/17/2022
In this white paper, we dig deeper into the sources of β-glucan, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product.
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Potent Rifampicin Derivatives Can Clear MRSA Infections At Single Low Doses When Concomitantly Dosed With Vancomycin
1/4/2024
Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies
2/24/2023
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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Optimizing Your Clinical To Commercial Journey
8/22/2022
How should you think about optimizing the journey from the development stage of clinical trials to commercialization? Review considerations to eliminate avoidable delays and have a seamless transition.
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Increasing Bioavailability With Amorphous Solid Dosage Formulations
11/10/2023
Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.
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Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs
8/14/2023
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.