Newsletter | June 7, 2023

06.07.23 -- Not All Plate Counting Technologies Are The Same

Featured Editorial
Industry Insights
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.

Advances In High-Throughput Upstream Process Development

Our expert authors explore temperature effects on product titer automated cell culture development workflow, maximizing DOE strategies and data management.

Viral Clearance: Something Went Wrong, What Do I Do Now?

Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Learn how to troubleshoot these and manufacturing deviations that impact viral safety.

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. 

A Compliant-Ready Workflow For Peptide-Based Multiple Attribute Method

Here, we demonstrate an end-to-end analytical workflow developed for the peptide-based multiple attribute method (MAM) with a platform that provides a compliant-ready environment for automated data acquisition.

Components Of An Effective Disinfectant Prequalification Strategy

Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.

Accelerating Cell Culture Media Manufacturing: Rapid Prototyping To cGMP

Learn ways to decrease logistical roadblocks, increase quality, and simplify the journey from finalization of media performance to scale-up, including how media analytics help optimize prototyping formulation.

Intensified Fed-Batch Process Using N-1 Perfusion And ambr® 15

Learn how to combine N-1 perfusion with the ambr 15 bioreactor system to create a powerful tool for rapid development of a highly efficient cell culture process.

Cell-Free Expression Of A Vaccine Candidate In Scalable Bioreactors

Currently, no licensed vaccine is available to prevent shigellosis. Explore the results of a study of IpaB expression optimization and scale up.

An End-To-End Industrialization Roadmap For Autologous Cell Therapy

Explore specificities and challenges, leveraging automation for scalability with the Cocoon® Platform, and building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.

Epigenomic Programming With Omega Therapeutics’ Mahesh Karande

Designed at the intersection of engineering and biology, an exciting new drug mechanism aims to target and resolve a wide range of diseases at the pre-transcription level.

Fc-fusion Cell Line Development: Expression & Analytical Solutions

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.

Improve Biopharma Fermentation With Innovation, Collaboration

Organizations developing products requiring fermentation often create custom processes from scratch, leaving room for inefficiencies, lost value, and, in the case of significant error, costly time delays.

Is It Better To Develop And Manufacture A Drug In-House Or To Outsource?

While this critical decision is not novel for the life sciences, the factors impacting it change year to year and have become increasingly complex.

From Bench To Batch: Strategies For Scaling HPAPI Production

Highly potent materials bring additional challenges to manufacturing processes. Examine considerations for optimizing HPAPI production methods to reduce risk and deliver therapies to patients with speed.

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