Newsletter | July 20, 2021

07.20.21 -- The Future Of Tissue-Based Therapies On Cell & Gene: The Podcast

 
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5 Key Takeaways: Drug And Device Development Secrets In The World Of Medical Aesthetics

New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. Premier Research explored this evolving landscape in depth in our recent webinar “Drug and Device Development Secrets in the World of Medical Aesthetics.” In this blog, we discuss five of the most important takeaways for creating a competitive, differentiated aesthetic development program.

Payers Create CAR-T Approval Systems As Adoption Increases

Spurred by CMS’s decision to cover CAR-T cell therapies under Medicare, commercial payers are beginning to systematize approvals for CAR-T treatment as use of these breakthrough cancer therapies is beginning to ramp up. In this article, experts weigh in on factors driving authorizations now and what to expect as more CAR-T therapies are approved.

Transportation Solutions For Cell And Gene Therapy Supply Chains

Developing a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.

Forget Lean Cleanroom Construction, Practice Lean Installation

Lean construction, as a buzzword, gets a lot of play in the cleanroom industry for good reason. It is an idea that got its start with Toyota in the 1950s to maximize efficiency and eliminate waste in production. With lean installation we take out almost all the risks to your commissioning and manufacturing timeline before our modular walls, ceiling, or HVAC components even make it to your site. In this blog you can learn more about how the benefits of this practice could benefit your company.

Simplifying AAV Protein Analytics With Maurice

Adeno-associated viruses (AAVs) are promising vectors for the delivery of genetic material in gene therapy. During the manufacture of AAVs, critical quality attributes (CQAs) such as charge heterogeneity, purity, and empty/full status must be carefully monitored because they can impact the product’s safety and efficacy. This poster demonstrates how we used a single Maurice platform to analyze AAVs by icIEF and CE-SDS methods to ensure product stability, identity, and purity.

Shipping Temperatures For Cell Therapies

Cryopreserved cells are often stored at a central facility before being shipped to the clinical location. This study explores the required shipping and storage temperatures for cryogenic cold chain delivery of biological samples.

Efficient Lentiviral Vector Production In A Chemically Defined, Blood-Free And Serum-Free Medium, Scalable To The iCELLis Bioreactor Technology

In this poster we explore the optimization of parameters for lentivirus production in serum-free medium flatware. To determine if a serum-free, blood-free, chemically defined medium could be used for lentivirus (LV) production at scale with adherent HEK293T cells, production parameters were first optimized in flatware. Second-generation pseudo-typed LV was produced in OptiPEAK HEK293t medium and compared to DMEM+10% fetal bovine serum (FBS), which is traditionally used for adherent HEK293T.

5 Common Clinical Supply Chain Speedbumps

Clinical trials are so complex, you need to connect planning and oversight from sourcing to shipping and master such requirements as cold chain, border slowdowns, and data privacy.

Pandemic Demand Forces Rapidly Increased Production And Expertise

Solis BioDyne, one of the leading reagent suppliers in Europe, manufactures a ribonuclease inhibitor used in COVID-19 diagnostic tests. Previously manufactured at bench scale, the company now needed to quickly increase production 50-fold to meet demand.

10 Tips For Setting Up A Successful Cell Sorting Experiment

Presented here are some tips to keep in mind when starting a cell sorting experiment. They will help you to maximize cell viability, separation, and isolation and set you up for successful downstream applications.

Sort Cells Using Data In Real Time

Researchers working in flow cytometry require the highest-quality data from every sample in order to achieve increasingly challenging scientific goals. The Bigfoot Spectral Cell Sorter’s acquisition and sorting application, Sasquatch Software (SQS), allows the operator to sort and analyze either spectrally unmixed data or traditional compensated data. In this paper, we will demonstrate a cutting-edge technique of combining spectral workflow and multiparameter six-way cell sorting.

Manufacturing Innovation Across New Modalities

The successful outcomes delivered by cell and gene therapies, coupled with the emergence of modalities across nucleic acid therapeutics and microbiomes, pose the next challenge for innovators to make these new modalities available at scale.

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