Newsletter | June 10, 2021

06.10.21 -- Thermo Fisher Scientific's CEO On Partnering In Cell & Gene Therapy

 
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Efficient Pharmaceutical Cleanroom Commissioning Methodologies

With both speed-to-market and lives in the balance, a lot of pressure will be brought to bear on your commissioning plan. Commissioning is the systemic and documented approach to verify that your cleanroom performs as designed and in accordance with your manufacturing needs. Read more about the components that make up your commissioning plan.

8 Ways Osmolality Tests Improve Cell And Gene Process Development, Manufacturing

Cell and gene therapies have the potential to revolutionize incurable, debilitating, and often fatal diseases. This paper outlines eight emerging and novel uses for osmolality testing in advanced therapy production.

Controlling Complexity (Not Cost) Of Advanced Therapy Supply Chains

Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex. Once efficacy and safety are demonstrated, the focus of advanced therapy developers moves to controlling cost. However, the biggest cost within the supply chain is caused by its complexity. In this article, we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.

How Can A Closed CAR-T Manufacturing Process De-Risk Your Process, Reduce Costs, And Improve Efficiency?

Though promising, CAR-Ts remain costly and largely a difficult manual manufacturing process. To create long-term solutions, developers are working on process improvements, such as system closure, that will boost safety and reliability and help to reduce costs. This blog will explore how developing customized solutions for system closure can solve a key technical bottleneck and advance CAR-T manufacturing.

Six Strategies To Improve Your Approach To Fill/Finish Manufacturing

Demand to increase speed and flexibility while maintaining sterility spurs the adoption of novel technologies and materials, all of which introduce new challenges.

Perspectives On Gene Therapy: Defining And Demonstrating Value To Payers

Since August 2017, we have seen the approvals of the first chimeric antigen receptor (CAR) T-cell therapies and the first directly administered gene therapy. Though these novel treatments are offering new hope to patients with unmet medical needs, they come at a significant cost, raising important questions about how novel therapies should be evaluated and paid for. In this white paper, we explore the current landscape of gene therapy to highlight the challenges payers, health systems, and manufacturers face in bringing these innovative medicines to the patients who need them most.

Considerations For Improving Outcomes In Biopharmaceutical Process Development

In this article, we look at how biopharmaceutical process outcomes can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

The Relief Through Customized Manifolds

A CMO faced a challenge with the commercialized automated filling of small bags with a volume of 500 ml. There were 1,000 bags to fill per batch. None of the single-use manifold assemblies matched the requirements of the CMO. Read how a customized solution of single-use manifolds was the solution.

Groundbreaking Work Leads To First Gene Therapy Ever Approved In Europe

Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in completely uncharted waters — our team had to create industry best practices that didn’t exist before, anywhere. With no classic route to market, Veristat’s experts created the map on patient recruitment, regulatory and health agency engagement, natural history studies, and the Central Site Model.

Navigating The Road To Gene Therapy Commercialization

With increases in development and investments in the gene therapy field, companies will increasingly be looking at manufacturing and commercialization of their therapies. The road to commercialization goes through a series of process validation phases. In this webinar, we take a closer look at the road to commercialization and focus on addressing primary questions.

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