Newsletter | November 22, 2022

11.22.22 -- Viral Vectored Vaccines: Assessing Their Quality

Featured Editorial
Industry Insights
14 Real Estate Strategies To Reduce Costs In Life Sciences And Fuel R&D

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.

Overcome Single-Use Customization Misconceptions

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.

Long-Term Follow-Up Studies: Gene Therapy Products, Protocols, And Potential Issues

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.

Gene Therapies: From Research To Reality

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

Radical Schedule Reduction Design And Construction Strategies For Life Sciences

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.

Developing Your Human Factors Risk Assessment And Evaluating Critical Tasks

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.

Achieving Next-Level Quality With Digital Technology In Manufacturing

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.

Characterizing Lentiviral And Gammaretroviral Vectors By Batch DLS And FFF-MALS

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.

Crystallization Process Development: Peptide Crystallization

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.

Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA

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.

Lentiviral Vector Producer Cell Line Generation For CAR T Cell Therapies

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

Let The Future Start Today: Development Of Better LNP-Based Genetic Medicines

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

10 Questions Investors Ask — And How To Respond To Them

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.

Alternatives For Low- And High-Throughput RNA Isolation/Extraction

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.

Recombinant Adeno-Associated Virus Type 5 Production Process

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

Developing Market Access And Distribution Strategies In CAR T Cell Therapy

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.

Specialized Scientific Support Streamlines Clinical Trials

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.

Incorporating Automation Into Your Fill And Finish Procedure

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.

Post-Discovery Priorities: Streamlining Your Molecule’s Route To IND

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

Ensuring Viral Vector Supply For Gene Therapies

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.

Automation Of T Cell Expansion Using The iLine F Microscope

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

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