Whitepapers

Delivering COVID-19 vaccines to 7.8 billion people was a daunting challenge that stretched supply chains past their limits. This white paper dives into vaccine distribution plans and what vaccine manufacturers, distributors and administrators can take away from this monumental time in both the industry and history. Learn how temperature indicators and monitoring solutions played an essential role in the administration of the COVID-19 vaccine.

With telemedicine, more medications and diagnostics are being shipped directly to patients’ homes and – for diagnostics, from a home to a lab. Discover how a freeze indicator can guarantee this precious cargo does not freeze during the process. A simple visual check alerts the recipient if the temperature has been unacceptably cold.

With millions of doses of the influenza vaccine being administered during the flu season, it's essential to make sure every vaccine is well protected. Discover how indicators can trigger only when product temperatures have exceeded maximums for a specific period of time. With at-a-glance ease, healthcare professionals can know instantly whether vaccines maintained proper temperatures during shipping adding confidence that vaccines have maintained their efficacy.

Data loggers, data monitors and temperature indicators are three reliable solutions for determining what has occurred during shipping and handling of pharmaceuticals. Deciding which temperature monitoring solution will work best for your operation depends upon the product, its value, delivery method and stage in the supply chain. Discover which solution is right for you in our white paper.

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.

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.

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.

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.

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.