Don’t miss our top posters and presentations of 2021! I have compiled a list of our most popular for 2021 in alphabetical order.

Accelerating drug development by employing established platforms and pathways

There are many challenges faced by biopharmaceutical start-ups in navigating through the discovery, development and commercialization pipeline that can be barriers to forward progress. Backed by years of expertise and a diverse portfolio of products and services to support these workflows, MilliporeSigma offers services that can help identify a path forward, no matter how complex the molecular journey. This is especially true for cell and gene therapy developers where a process template may not exist requiring you to draw your own path as you go, despite uncertainty and unique challenges, to meet the urgent needs of patients. This video published by MilliporeSigma highlights the best practices for biopharmaceutical start-ups at every stage, from development to outsourcing and regulatory guidance…

Fit for purpose, closed automated cell processing system provides improved cell therapy workflows for research through manufacturing

Cell and gene therapies are poised to provide a vast new arsenal of therapies to treat disease. Much like monoclonal antibody manufacturing in the early 1980’s, cell and gene therapy manufacturing is constantly evolving with improved fit-for-purpose technologies being developed to meet expanding industry need. Despite smaller volumes, cell and gene therapy manufacturing is more complex and labor intense than protein-based biologics. Cell and gene therapy processing requires multiple steps and procedures including cell separation, concentration, washing and others. For a successful cell therapy to be produced, it is important to be able to conduct these activities as simply, safely and efficiently as possible…

Gaining Real Time Bioprocess Insights Using Raman Spectroscopy

Mammalian cell culture is an integral part of biopharmaceutical manufacturing, but in-process monitoring strategies often lack real-time measurements. Unfortunately, the process mostly remains a highly manual low-throughput process that can increase the risk of batch contamination. Advances in process analytical technology (PAT) have surged because of industry-wide adoption of Quality by Design (QbD) principles. QbD seeks to build the quality of a product into the manufacturing process itself rather than simply relying on end-product testing. PAT plays an integral role in QbD since it can provide important metrics during the manufacturing run for bioprocess insight. These metrics not only ensure consistent product quality but can also inform strategies to increase throughput and introduce automation to build efficiency throughout the workflow…

Get hassle-free AAV titer and empty/full characterization on Stunner

In this mini-webinar and accompanying article, Kevin Lance, PhD, Marketing Manager at Unchained Labs, shares how to obtain AAV titer and empty/full characterization quickly and efficiently with only a small amount of sample required. Kevin began the webinar by discussing the complexity of AAV characterization. Proper characterization requires the answers to several questions including: how much protein is present, how much DNA is present, are things intact, are they the right size and is there any aggregation. As a result, AAV characterization can’t be completed using just one method and thus several techniques must be combined to provide a full picture. In addition, the use of multiple methods and the sample volume required for most methods requires large sample volumes to complete AAV characterization work…

Get the fast, simple, and accurate DNA quant you deserve with Lunatic

In this webinar, Nelis Denys, Product Manager for Lunatic & Stunner, outlines the benefits of Lunatic and provides use-case examples for quantification of nucleic acids. The system is a full spectrum UV/Vis spectrophotometer with 96-well plates containing built-in microfluidic circuits and fixed measurement pathlengths. Capable of running 96 samples in ≤10 minutes with only 2 µL of sample, this unique platform has a wide dynamic range of 0.03-275 OD (0.5 – 13750 ng/µL dsDNA), which eliminates the need for sample dilution…

Hassle-free nanoparticle characterization with Stunner

The ability to execute rapid and accurate nanoparticle characterization was the focus of a recent webinar presented by Nelis Denys of Unchained Labs. As Nelis described, once a nanoparticle platform is produced, there are two key questions developers will need to characterize: nanoparticle size and payload concentration. Stunner platform by Unchained Labs is uniquely designed to be able to address these two attributes simultaneously with its UV/Vis and dynamic light scattering (DLS) technologies. UV/Vis absorbance determines the total payload concentration while DLS is used for nanoparticle sizing. Nanoparticle sizing is particularly important, with numerous publications identifying a correlation between nanoparticle potency (effective dose) and size…

Rethink T Cell Therapy with Lipid Nanoparticles

Lipid nanoparticles (LNP) have been clinically validated to successfully deliver RNA, from the first approved siRNA-LNP Onpattro^®, to mRNA-LNP COVID-19 vaccines from Moderna and Pfizer/BioNTech. RNA-LNP leverage existing endogenous cellular uptake pathways to enter the cells, making this technology a gentle method to introduce genetic materials…

Proteogenomic Strategies to accelerate Drug Discovery and Increase Success

There are countless diseases that are in desperate need of new, more effective therapeutics to address unmet needs or to improve current standards of care. Addressing these needs is no easy task considering the long timeline to approve new drugs coupled with how few drugs successfully make it through clinical trials in the first place.

The challenges of moving a therapeutic candidate through clinical trials was highlighted in the report Biopharmaceutical Research & Development: The Process Behind New Medicines, published by PhRMA. In the report authors’ state that the process for researching and developing new medicines is growing in difficulty and length with the overall probability of clinical success estimated to be less than 12%…

Sterile Connections – A Critical Part of Fluid Transfer in Viral Vaccine Production

Being able to move fluid aseptically using sterile connections is a critical part of the viral vaccine production process. Sterile connections are responsible for how fluid is transferred from one technology to another unit operation. From upstream to downstream and into final formulation and fill, there are multiple points of fluid transfer in vaccine production. The points of transfer must be sterile and failsafe to avoid lost batches due to contamination and ultimately to ensure patient safety. Too often, creating these sterile connections and processes can take considerable time and resources. One challenge is that many available connectors are difficult to use and thus there is an increased risk of failure…

Understanding Cell Culture Media

Cell culture media greatly impacts biomanufacturing in both positive and negative ways. Variability in cell culture media and associated raw materials can create variation in the upstream manufacturing process, as well as impacting final product quality. New analytical technologies have made it possible to have a better understanding of what contributes to cell culture media variability and as a result it is incumbent on cell culture media suppliers to implement control processes and a robust quality assurance program…