Whitepapers

Innovations in the use of viral vectors as a gene delivery vehicle are a key factor in the growth of the gene and cell therapy field. However, the long-term impact of viral vectors requires continued research in their design to address both efficacy and the problems with immunogenicity and toxicity.

This benchmarking study compares the Advanced Instruments Solentim ICON™ viability assay to the performance of a commercially available cell counter. The results demonstrate lower variation, increased precision, and time savings.

There’s no doubt clinical research has changed. With 77% of surveyed pharma executives planning to run a hybrid or decentralized trial this year, it’s important to understand the benefits of web-enabled research tools and how they work. Learn the benefits of DCTs with this eBook.

Medable eConsent improves the trial experience for patients, sites, & sponsors. Learn how eConsent in conjunction with other decentralized solutions helped save one organization save $20M in trial costs, reduce trial site visits by 75%, and cut enrollment timelines in half with this case study.

The goal of this paper is to introduce and support the use of osmolality in the Downstream Ultrafiltration/Diafiltration (UF/DF) process steps in the mAb workflow.

The data is conclusive, DCTs provide better returns on investment than traditional trials. In fact, new analysis by Tufts CSDD shows DCTs can provide up to 13x ROI in phase III trials & 5x ROI in phase II trials through reductions in clinical trial cycle time, screen failure decreases, and more. Learn more with your free copy of the analysis.

A recent study by Morning Consult finds that >54% of US adults would be willing to participate in a clinical trial if it had a 30-minute-or-less commute. This is quite striking, given that <4% of the 328 million people in America are actively participating in clinical research today. The solution? - An accessible, intuitive digital clinical platform that connects sponsors, sites & patients, and replaces burdensome paper forms and physical visits with electronic consents (eConsent), electronic Clinical Outcome Assessments (eCOA’s), and remote visits (TeleVisits). Find out how Medable, the recognized industry leaders in Decentralized Clinical trials, can partner with your organization to digitally transform your clinical protocols. Your research teams can experience benefits such as; improved patient experience, higher quality outcomes data, & savings of US$25,000,000+ for individual studies. Download the White Paper now to learn how.

This benchmarking study compares the Advanced Instruments Solentim ICON™ viability assay to the performance of a commercially available cell counter. The results demonstrate lower variation, increased precision, and time savings.

The goal of this paper is to introduce and support the use of osmolality in the Downstream Ultrafiltration/Diafiltration (UF/DF) process steps in the mAb workflow.

Using a pre-packed column platform enables seamless scale-up for downstream process purification. We demonstrate that neither the capacity of the packed resin nor the separation efficiency is affected when increasing the column volume.

The 5’ capping is a CQA for mRNA vaccines and therapeutics, and needs to be fully characterized. Learn a sensitive, robust LC-HRAM-MS/MS method for identification and quantitation of 5’ cap.

Learn about the key benefits of adding automation to flow imaging microscopy and how these are implemented in ALH for FlowCam™

In this application note we show how flow imaging microscopy and FlowCam can help analyze particles in biotherapeutic samples. To demonstrate this ability, a simulated protein formulation consisting of silicone oil microdroplets spiked in a protein formulation was prepared and run on a FlowCam 8100 FIM instrument and analyzed with VisualSpreadsheet software.

In this white paper, we utilize FlowCam LO to obtain simultaneous Flow imaging Microscopy (FIM) and LO measurements of a single sample. The results demonstrate that LO can undersize or even completely fail to detect highly transparent particles such as ETFE and some protein aggregates that FIM easily detects. These results highlight the importance of pairing LO measurements with an orthogonal technique like FIM.

In this white paper, we demonstrate the analysis capabilities of FlowCam Nano for biotherapeutic formulation development. This study compares the results from FlowCam Nano with those from FlowCam 8100 when analyzing samples containing protein aggregates, sucrose particles, and bacteria. We also demonstrate the consistency of the particle concentration measurements with FlowCam Nano and how the instrument may also be used to determine relative particle concentrations in samples.

In our new white paper, we present detailed performance results for FlowCam's Artificial Intelligence software, VisualAI, using images of different protein aggregates including monoclonal and polyclonal antibodies and silicone oil that were obtained with multiple FlowCam 8100 instruments. We also demonstrate VisualAI’s effectiveness at measuring protein aggregate content in samples with known ratios of protein aggregates and silicone oil droplets.

To gain a better appreciation for saliva and its growing use within the diagnostics research market, we’ll take a closer look at some foundational questions about saliva’s composition, physiological function, and its underappreciated history in the medical field.

Insights from lab data – often separate from the enterprise – is increasing as AI and machine learning move into the lab. Explore this shift from data collection to data science.   

The clinical value of biologics for the treatment of many disease indications has been accompanied by phenomenal sales. By 2026, the global market for biologics is projected to increase to $537 billion. However, getting a promising drug candidate can be daunting. This white paper details how to optimize formulation development and tech transfer to ensure successful biologics production.