Newsletter | April 6, 2021

04.06.21 -- Are CTLs A Game Changer For COVID-19 Treatment?

 
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A Modern Take On Cell Therapy Logistics

Here are my highlights on an International Society of Cellular Therapy (ISCT) 2020 session that introduced a new way to ship and transport cellular materials, putting patients front and center.

CDMO Time Bmbs: Five Ways The Wrong Partner Can Lead To Trouble Down The Road

Overcoming the technical challenges of developing and manufacturing biologics is a tall order. You need cutting-edge technology, razor-sharp data analytics, and streamlined processes to establish a quality product, navigate high regulatory standards, and meet ever-changing market demands. 

Avoiding The Potholes Along The Pathway To Commercial Cell Therapies

Invetech hosted a panel discussion during the recent International Society Cell & Gene Therapy (ISCT) conference in Melbourne, Australia, to explore the main challenges along the pathway from process development to commercial cell therapies. Read about the panel's insightful discussion on the role that considered automation plays in navigating three of the biggest potholes in commercial cell therapies.

How To Prepare For Future Viral Vector Manufacturing Technologies And Platforms

The challenges and shortage of vector production reflect the fact that these materials and products are having strong clinical success. Let’s celebrate the reason for this demand. To meet it, we need to industrialize and rethink how we transition from what has historically been carried out in translational clinical centers at smaller scale, using flasks and open systems, toward commercial production and methodologies.

Determining Residual Bead Count: Application Of Microflow Imaging To CAR T-Cell Manufacturing

Residual bead count is typically determined manually by the naked eye and microscopy. But this approach is highly limited in its ability to accurately discern beads from cells and other potential in-process impurities, resulting in reporting uncertainties that risk regulatory approval. In this application note, you’ll see how automation via image-based microflow imaging (MFI) technology gets you the quantitative and morphological data you need to have confidence in distinguishing between beads, T-cells or other potential contaminants.

Addressing The Talent Shortage For CDMOs

Industry expert Mayo Pujols, CEO of Andelyn Biosciences, offers his perspectives on addressing the workforce challenges in the clinical manufacturing field.

Data Integrity And Compliance: What Every Lab Should Know

While FDA 21 CFR Part 11 allows life sciences organizations to use e-records in place of paper, a piece of software by itself cannot be compliant. Here's how to develop and perform GMP validation.

Cell Therapy Development And Improving Patient Access

"The first thing that comes to mind is patient access, because there’s an inherent issue if a therapy is egregiously unaffordable. If we can change how cell therapies are manufactured — and how much it costs to make them — we can increase patient access." Read more from VP of cell therapy marketing, James Lovgren, on how we can address major challenges in cell therapy development.

Vaccine Development: Strategic Approach And Response During Pandemics

Over the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have sparked ongoing conversations about strategic approaches and responses to pandemics and epidemics. Now, with the spread of COVID-19 intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring these life-saving drugs to market faster without impacting product quality, safety, or efficacy.

Low-Temperature Solutions For Bioprocess Applications

Explore the needs and requirements of equipment and processes to handle lower temperatures, including a complete, cold-resistant solution of bags, tubing, connectors, and shells for freeze/ship/thaw processes.

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