Newsletter | July 1, 2022

07.01.22 -- mAb Manufacturing: Overcoming Platform Inefficiencies

 
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Early Plasmid Optimization For Long-Term Commercial Success

Securing the right plasmid for an application can be a complex endeavor. Core to this is selecting a supplier with the quality assurance protocols and GMPs to facilitate optimized plasmid production.

How mRNA Technology Is Shaping The Future Of Medicine

Discover how mRNA technologies open the doors to a whole range of new gene therapies and the role of lipid nanoparticles (LNPs) in current and future developments.

Taking Biotherapeutic Candidates From Late Discovery To The Clinic

Many initially promising biotherapeutic candidates fail due to lack of efficacy or safety, but there are candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. 

Virus Reduction, Impurity Removal With Nuvia aPrime 4A Resin

To prevent costly changes to a manufacturing process, it is important to assess each operation unit for efficiency of adventitious agent removal or inactivation during downstream process development.

Explore Alternative Analytical Methods To Solve Process Challenges

Successful and rapid analytical method development plays a key role in ensuring the development of robust processes to produce high-quality products. 

Addressing Upstream Cell Culture Challenges As A Community

See how the Advanced Mammalian Biomanufacturing Innovation Center (AMBIC) is working with new data sources to improve process modeling.

Building More Resilient API Supply Chains

It is important to pursue a dualistic, longer-term supply strategy that embraces cost control and supply reliability/diversity to improve the integrity and resilience of international supply chains.

Understanding The Roles Of Solid-State Characterization And Crystallization

Explore the importance of developing an early understanding of key solid-state properties for successful downstream processes and tips for building a robust knowledge base in solid form drug development.

Why More Drugs Than Ever Are Approved Through 505(b)(2)

Discover how bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity.

Filling Industry Gaps With Dedicated Cell And Gene Therapy Fluid Transfer Sets

Read how the incorporation of transfer sets designed to support CGTs will aid in the implementation of controllable, consistent, and safe cGMP amenable manufacturing procedures.

Lentiviral Vector Analysis For Cell And Gene Therapy Made Simple

We demonstrate Simple Western’s analytical capacity to simultaneously characterize multiple parameters of LVVs, including viral titer, stability, purity, and capsid content.

Cell Line Development: Experience More Stable Clone Development Freedom

Learn about a beginning-to-end workflow solution for the production of stable cell clones and its flexible, royalty-free commercial licensing options.

Predicting LRV Through The Use Of A Non-Infectious MVM Surrogate

Discussed here are results from studies that utilized a non-infectious mock virus particle as an MVM surrogate, demonstrating the value to be gained from a QbD approach during process optimization.

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