Biosimilar White Papers
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Strategies For Ensuring Biomanufacturing Resilience For Biologics
6/29/2023
Long-term collaboration in resilient biomanufacturing capacity and supply chains ensures the reliable delivery of health technologies. Investigate biomanufacturing resilience strategies for biologics.
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Establishing Analytical Methods For mRNA-Based Therapies
6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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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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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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How Can The Industry Drive Down The Cost Of Viral Gene Therapies?
4/5/2023
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
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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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Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization
8/25/2023
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
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The Dynamic Regulatory Environment Of Drug-Device Combination Products
11/29/2022
Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
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Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development
12/27/2023
Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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Taking Charge Of Your Stability Program
10/5/2022
Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.