Newsletter | September 22, 2022

09.22.22 -- Limitations Of Precision Medicine?

 
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Industry Insights
Will The Real Critical Tasks Please Stand Up: How To Develop Your Human Factors Risk Assessment And Evaluate 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.

Why Decentralized Research Is The Path To Inclusive Medicine

In the U.S. today, Latin Americans account for 18% of our total population, but only 1% of enrolled trial participants. At this rate, the industry will make medicines that are only effective for half of our population by 2045. Learn about the problems with diversity in clinical trials, and how we can address them.

Lipid Nanoparticle Development, Manufacturing Advance Novel Therapeutics

An effective partner must possess the necessary unique analytical capabilities for LNP characterization and the ability to support clients from concept to commercialization.

Challenges And Innovation In Gene Therapy Manufacturing

The road to final approval for a biotherapeutic is long and filled with obstacles, from manufacturing and scale-up to regulatory adherence and business practices.

Controlling Risk: Poor Analyte Recovery And Lack Of Assay Robustness

A robust peptide MAM assay requires an LC system that delivers an unbiased and consistent protein digest separation. This work demonstrates increased peptide recovery and robust MS response.

Improved Lentiviral Vector (LVV) Purity With Multi-Modal Chromatography

Polishing involves the removal of major impurities such as residual host cell DNA and protein. Examine the utility of multi-modal chromatography as a novel strategy during polishing to improve lentiviral vector (LVV) purity.

Gene Therapies: Transformative Medicines

Gene therapies are transformative medicines that hold promise for treating diverse genetically driven diseases. Explore the essential components of a gene therapy.

The Critical Role Of CDMOs In Driving Biomanufacturing Resilience

CDMOs play a critical role in advancing the growing pipeline of novel product types, as innovators can utilize the advantages of these strategic collaborations until they are more assured of the future of their projects.

Commercializing Advanced Therapy Medicinal Products (ATMPs) Manufacturing Processes

Improving this one aspect of viral vector manufacturing can help enable scalable production of high-quality vectors with acceptable costs and timelines.

Continuing The Conversation: The Future Of Reimbursement For Cell And Gene Therapies

Cell and gene therapies were expected to pose significant payer challenges; however, several high-cost cell and gene therapies have achieved rapid and broad reimbursement to date across major payer bodies.

Single-Use Bag Particle Testing To Ensure Surface Cleanliness

This application note explains the use a liquid particle counter to qualify the cleanliness of single-use 2D bag assemblies.

Media Adaptation For Suspension Cells

We review a procedure to adapt suspension CHO and 293 cultures, which also serves as a general protocol that has been successful with multiple other cell types and media.

Closed Manufacturing System For Autologous Cell Therapy Production

A complete manufacturing system delivered technology innovation, novel automation solutions, and substantial IP in the cell therapy manufacturing automation domain.

5 Things We Need To Do To Improve The U.S. Healthcare System
Mark Sawicki, Ph.D., chief executive officer at Cryoport Systems, shares his perspective of the current state of the healthcare system, what areas can be improved, and specific steps to achieve the change.
Sample Tracking With SampleGISTICS Technology

See how LabConnect’s SampleGISTICS provides real-time sample tracking to monitor your valuable samples.

The Impact Of Compensation On Clinical Trial Participation

See the results of a joint survey with 1nHealth on how compensation is likely to impact participation in clinical trials, followed by a thought-provoking roundtable on this timely topic. 

Confronting Scalability With Autologous Therapies

Autologous immunotherapies have evolved to provide breakthrough treatments, but complexity of the production process often results in extended timelines and high manufacturing costs.

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