Outsourced Pharma White Papers
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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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CRISPR RNPs And The Future Of Cell And Gene Therapy
4/21/2023
Explore the potential of ribonucleoprotein (RNP) to deliver CRISPR materials more accurately, efficiently, and effectively, as well as the manufacturing challenges which require further attention.
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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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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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Validated LC–MS/MS Method For The Determination Of Copanlisib
11/14/2022
Review study findings on a validated LC–MS/MS method for quantifying copanlisib from a mouse dried blood spot and its potential for enabling desirable sensitivity, accuracy, and precision.
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Advancing A LNP Formulation To Clinical And Commercial Manufacturing
3/21/2024
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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The Business Case For Pharmaceutical Continuous Manufacturing
6/2/2023
Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
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Spray Drying To Enable New Inhaled Drug Products
7/11/2023
The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.
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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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Overcoming Challenges In AAV And LV Viral Vector Manufacturing
12/5/2023
Manufacturing viral vectors leaves sponsors vulnerable to high costs, delays, and the possibility of failure. The right CDMO partner can help you reduce timelines and costs for viral vector production.