Outsourced Pharma White Papers
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Navigating The Regulatory Maze: Fundamentals For Drug Development
7/15/2022
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
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Clear MRSA Infections At Single Low Doses
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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COGs Process Economics For Autologous Cell Therapy
8/11/2023
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.
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Switching To Direct-To-Patient Rapidly In The EU
10/4/2022
Explore the logistical risk management factors to consider when deciding to switch to direct-to-patient shipments in the EU.
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Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations
7/12/2022
Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.
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Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying
3/10/2023
A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.
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Extractables And Leachables: Risk Management And Analytical Solutions
10/11/2023
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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Quantitation Of Monoclonal Antibodies In Serum
2/8/2024
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
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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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Developing A Scalable RNA-LNP Drug Product For Clinical Translation
9/22/2022
Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.