Biosimilar White Papers
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Optimizing Lipid Formulations For Targeted RNA-LNP Applications
9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
-
Process Development Considerations For RNA-LNP Therapeutics
9/13/2022
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
-
The Latest Trends In The Prevention And Treatment Of Cervical Cancer
2/8/2024
Unearth what immune checkpoint inhibitors are showing promise in treating cervical cancer and how advancements in these treatments paired with additional prevention strategies are improving patient outcomes.
-
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.