11.22.22 -- Viral Vectored Vaccines: Assessing Their Quality

The life sciences industry has risen to the occasion in the fight against COVID-19. Yet the pandemic has disrupted research, clinical trials, and supply chains in a sector already facing significant challenges.

Single-use strategies and tools are constantly evolving to better serve industry needs, and adept solutions providers can help streamline development with simple, custom adaptations.

A “long-term” study is one that gathers data on research subjects for five years or more. Learn about several arguments for conducting studies to assessing the long-term risk of drugs in this blog.

Partnership scrutiny is critical for cell and gene sponsors transitioning from pure R&D and early preclinical work into clinical-phase development.

Read insights into the challenges, solutions, and key considerations to optimize success when looking to radically reduce design and construction schedules for research lab projects.

Determining the appropriate critical tasks to be evaluated and assessed is crucial to the human factors engineering (HF/HFE) process and needs to be addressed with the appropriate risk-based approach.

Learn how a modern manufacturing execution system is using digital production records to help manufacturers regulated by the FDA improve their quality and efficiency goals.

Discover how both batch DLS and FFF-MALS-DLS measurements can be applied in every stage of the manufacturing process for screening, quantitation, extended characterization, process development, and quality assurance.

Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.

Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.

A cell line development platform that enables the generation of producer cell lines (PCLs) directly in suspension, in accelerated timelines, has been successfully implemented.

Discover how you can accelerate the time to patients for new vaccines and therapies with innovative, streamlined technology that is quicker and more intuitive.

In building your new drug program, investors are betting on you to effectively manage development. Answering their questions well increases the likelihood of receiving support for your company’s vision.

This paper demonstrates that extraction column spin devices can efficiently isolate and purify high-quality RNA and genomic DNA with yields and qualities similar to devices found in commercial kits.

Learn about a scalable process for the production of rAAV using triple plasmid transfection of suspension cells in an animal-derived component-free medium.

A client was preparing for the U.S. launch of a CAR T cell therapy into a new, rapidly evolving, and highly competitive market. In order to move forward, they needed assistance assessing the current landscape and gathering relevant inputs needed for access and distribution strategy development.

Achieving appropriate scientific oversight and thorough, efficient sample management throughout studies are challenges that many pharma and biotech companies encounter. In this Q&A, explore a highly specialized outsourcing model that addresses these challenges.

Terumo Blood and Cell Technologies' Global Product Manager for Cell Therapy Technologies explains incorporating automation into fill and finish procedures and its impact on production costs and product quality.

Four experts in post-discovery strategy share insights into methodologies, robust platform process design, high-throughput automation technologies, optimized workflows, and life cycle approaches.

The rapid success of gene therapies also brings with it a number of challenges, the most significant being ensuring a sufficient viral vector supply, despite shortened development timelines. This infographic demonstrates how cells grown in suspension are much better suited for large-scale production of viral vectors, what to consider in order to successfully scale up your viral vector production, including the challenges faced in upstream upscaling, and a specific solution we’ve developed to help you address these challenges.

Learn how an online cell counting platform can improve process and product understanding through real-time attribute monitoring, plus more.