Newsletter | August 25, 2020

08.25.20 -- Immunotherapy For Glioblastoma: A Path Forward

 
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From The Editor
 

Greetings Cell & Gene readers,

 

I had the pleasure of interviewing experts from Eurofins, PhRMA, EMD Serono, MassBio, and Toft Group Executive Search about actionable ways to develop, implement, and require a diverse and inclusive working environment that drives innovation and profitability. Read their actionable and timely responses to my questions.

 

Glioblastoma (GBM) is a malignant, fast-growing, and aggressive primary brain tumor. Here’s a concise overview of the types of immunotherapy interventions that have been trialed in GBM, their associated challenges and shortcomings, and current approaches as a path forward for the field.

 

Erin Harris, editor in chief
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Industry Insights
Pharma Production Tech Transfers: Reaping Rewards, Reducing Risks

Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

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One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.

Advanced Therapies: Reimbursement And The Impact Of Hidden Supply Chain Costs

While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated. In this article, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.

Suspension-Based Process For Lentiviral Vector Production Using A Stable Inducible Cell Line

Scale-up is a major hurdle in the production of lentiviral vectors (LVV) for use in gene therapy, as traditional methods for production involve transfection of adherent cells cultured in serum-containing medium. This poster evaluates a suspension and serum-free adapted stable inducible LVV producer cell line (Broussau et al., Mol. Ther. 2008) for the production of third-generation LVVs carrying the GFP transgene.

Unifying Cell Therapy Logistics And Manufacturing

The supply chain and logistics for cell and gene therapies are especially critical to ensure the right patient gets the right treatment at the right time. Collaboration is the key to solving challenges such as data management and process variability, as stakeholders work toward a common goal — getting these life-saving treatments to the people who need them.

Extractables Testing On Single-Use Connectors

Appropriating BioPhorum Operations Group (BPOG) testing on single-use connectors to mitigate the risks of extractables and leachables (E&L), as demonstrated in this article, is crucial to delivering safe and effective drugs.

Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness Using “Manufacturing By Design” Methodology

Contract development and manufacturing organizations need to play a critical role in the scale-up and industrialization of cellular therapies by providing customized tools and processes. The manufacturing by design approach for addressing the industrialization of cell therapies allows for optimal production conditions.

Understanding The Road To Commercialization

With the current increase in development and investment, gene therapy companies will increasingly be looking to streamline the manufacture and commercialization of their therapies. Choosing a contract development manufacturing organization (CDMO) to ensure a smooth road to commercialization is essential. Contact us directly to learn more about picking the right strategic partner.

Risk Mitigation Critical For Successful Cleanroom Construction Projects

Your cleanroom design-build project is critical to the success of producing your product, whether it be medicine, therapy, or device. Risk mitigation is critical to a successful cleanroom construction project. Learn how to prequalify potential contractors, subcontractors, and suppliers to minimize risk.

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