Outsourced Pharma White Papers
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A Scalable Single-Use Two-Step pDNA Purification Process
3/6/2024
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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Recommendations For Successful IND Approval Of RNA-LNP Drugs
8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
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Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing
6/1/2022
Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.
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Fc-fusion Cell Line Development: Expression And Analytical Strategies
5/15/2023
Understand high titer expression of Fc-fusion proteins using the Apollo™ X platform coupled with integrated quality assessments, enhancing support through the predicted growth in Fc-fusion clinical applications.
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PBPK Modeling For Optimized Controlled Release Formulation Development
8/24/2023
Examine the benefits of controlled release, the application of PBPK modeling in controlled release formulation development, and how modified release products can be developed to deliver optimal patient outcomes.
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Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs
8/21/2023
Explore how a platform which integrates drug substance, drug product, and clinical testing within a single organization accelerates development and reduces project costs, helping deliver positive outcomes earlier.
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Data Utilization For Advanced Analytics And Near Real-Time Monitoring
8/16/2022
Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.
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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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Revolution In The EU Pharmaceutical Legislation Ahead
2/8/2024
Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.
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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.