Whitepapers

This study aims to evaluate harvest strategies and metabolite-based cell density estimation methods for Lentivirus production with HEK293T cells.

Complete and clean trypsin digestion can be achieved with an enzyme that provides a balance of low levels of missed cleavage, non-specific cleavage, and trypsin autolysis. RapiZyme, a next generation trypsin, offers efficiency and reproducibility.

This technical note demonstrates the comprehensive characterization and confident identification of glucuronide metabolites from hepatocyte incubations of midazolam.

We offer a growing portfolio of well characterized monoclonal antibody (mAb) reference standards and associated characterization data.

There are multiple analytical techniques like ion exchange chromatography (IEX), Capillary isoelectric focusing (cIEF) or imaged capillary isoelectric focusing (icIEF) used for charge variant analysis. This technote is focused on cIEF and icIEF which are commonly used analytical methods for charge variant analysis.

This infographic outlines the USP resources that help ensure quality of monoclonal antibody therapeutics throughout the production process.

This application note presents a side-by-side comparison of the AdvanceBio and GlycoWorks kits for the preparation and analysis of released N-glycans.

This application note presents a side-by-side comparison of the AdvanceBio and GlycoWorks kits for the preparation and analysis of released N-glycans.

Antibody therapeutics are the largest class of biotherapeutics. Over the years, development beyond traditional monoclonal antibodies (mAbs) has increased. Today, we see multispecific and bispecific antibodies, antibody fragments, and antibody drug conjugates in the development pipeline. Manufacturing platform approaches conveniently used for many traditional mAbs are being adopted or tweaked to fit the respective molecule. In this ebook, you will learn about considerations and tips for developing chromatography protocols for antibody variants.

This application note demonstrates the efficacy of an in-line optical dissolved oxygen sensor that eliminates signal noise caused by air/oxygen bubbles.

Use flow imaging microscopy, light obscuration, and dynamic light scattering for particle analysis in protein formulations.

BridgeBio Pharma, Inc., and REGENXBIO Inc. take a novel approach to AAV capsid titer quantification by using Octet® AAVX Biosensors to generate viral titer data.

This customer note will demonstrate the suitability of SEC for a fast and reproducible evaluation of adeno-associated virus (AAV) product titers

Transmission Electron Microscopy’s key advantages is its unbiased nature, making it an ideal complement to in vitro assays and molecular techniques in determining the microbiological safety of biological products. The Eurofins Electron Microscopy laboratory can aid in evaluating the size, shape, and purity of viral particles, as well as assessing their capsid content.

Critical considerations for deploying smart, fast, and flexible Life Sciences facilities

Get ahead of cyber-attacks by keeping pace with the speed of IIoT innovation

Gene therapy products require extensive experience in bioassay development, optimization, phase appropriate method validation/transfer, as well as assay maintenance to support routine lot release and stability testing. Learn how Eurofins BioPharma Product Testing can support your gene therapy products.

Cybersecurity with Clarity and Rockwell Automation

Eurofins BioPharma Product Testing supports the development of cell and gene therapies by providing comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products as well as support for manufacturing process development and validation.

Eurofins BioPharma Product Testing’s dedicated Biologics Raw Materials testing team has vast experience in cell and gene therapy manufacturing from early clinical, through process validation, product optimization, and marketed release. Work with the team that has over 20 years of biopharmaceutical experience for your raw materials program.

Mycobacterium has been a concern in the vaccine industry for many years and now for the gene therapy industry. At the speed the industry is moving, faster and alternative approaches are needed to address speed of results as well as quantity of material needed. The Eurofins Mycobacterium complex PCR detection method can issue a COA in 10 days, requiring only 1-2mL of sample.

Through advanced technology, deep industry knowledge and an unwaveringly collaborative approach, our proven capabilities help life sciences companies succeed in a highly competitive and complex marketplace from targeted biologics to cybersecurity.

The rapid development of gene therapies and high demand for therapeutic proteins pose considerable challenges for biomanufacturing. Complex production processes, product changeover, managing supply chains, and staying ahead of the curve, to name just a few. To accelerate commercialization of biotherapeutics, organizations need to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy. The solution could be a comprehensive approach for screening and characterizing molecular interactions such as protein-protein or protein-drug interactions. It enables a huge variety of applications performed at various stages of biologics development — from early selection to validation to manufacturing. Based on Bio-Layer Interferometry (BLI), it enables real-time, label-free analysis for the determination of kinetics, affinity, and antibody/protein quantitation. Download this eBook to learn how the Octet® BLI platform can streamline workflows, reduce time-to-results, and costs saving on broad range of analytical applications in bioprocessing.

Read a compelling, detailed Case Study about how an innovation partnership with Waters Corporation enhanced Alcami’s capacity, efficiency, and compliance-readiness for their pharmaceutical manufacturing and analytical services to differentiate their offerings and drive business growth.

Discover how the Ramina Process Analyzer integrates with the 500L HyPerforma DynaDrive bioreactor to perform accurate in-line measurements and prediction models.

A 2-step platform to purify Pertuzumab is developed, using 1 mL and 5 mL pre-packed columns. Then, scale-up is demonstrated using 50 and 200 mL pre-packed columns.

Octet® BLI systems reduces CQA assay development and run time enabling fast and efficient analysis. Learn how BLI is utilized across a range of CQA applications.

This eBook highlights key considerations for navigating the supply chain as newer biotherapeutic molecules drive growth and support the innovation and manufacture of newer biologics.

Lipid-based nanoparticles (LNPs) are effective non-viral vectors for delivering messenger RNA products (mRNA), most notably used for vaccine production against the recent SARS-CoV-2 pandemic. In this executive summary, you will discover a robust and high-throughput kit-based analysis of nucleic acids extracted from different mRNA-LNP samples.