Learn how cell performance within the context of the cell line development workflow was confirmed with the successful isolation of stable, high-producing clones from three model monoclonal antibodies.
Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing can could solve three of these key challenges regarding instrumentation.
Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.
We describe the performance of two assays for titer analysis of adeno-associated virus (AAV), serotype 2 and serotype 5, based on surface plasmon resonance (SPR).
Follow the feasibility of xeno‑free NK cell expansion, closure of key unit operations, and how future work could focus on fine‑tuning each step to generate a robust, scalable process.
In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.
Learn about one facility's transition to closed processes for the expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.
A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.
To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.
Increasing constraints on today’s supply chain from the COVID-19 pandemic mean drug companies must secure strategies that can ensure product delivery in the face of these challenges.
Get the latest articles from Biosimilar Development delivered to your inbox.