Whitepapers

This guide explains how biopharmaceutical production and bioprocessing trends demand flexibility and consistency in R&D, scale-up, and production processes, requiring optimization through analytics. METTLER TOLEDO's sensor range meets these requirements, covering various reactor types, from benchtop bioreactors to stainless steel reactors and single-use bags.

CO2 impacts extracellular and intracellular pH and can directly and indirectly effect glycosylation patterns and molecule stability. This guide to CO2 gives an overview of the role that dissolved carbon dioxide measurement can play in bioprocess development, scale-up and manufacturing.

Dependable in-line measurement of oxygen levels in liquid and gaseous mixtures is vital for providing continuous, real-time O2 data to enable efficient process control. Our oxygen theory guide provides an overview of oxygen measurement theories, an explanation of amperometric and optical sensor technologies, and much more.

On average, cargo is handled seven times between a manufacturer and a client. As medical equipment moves through the supply chain and hospitals, it can experience mishandling which effects the performance and calibration of the product. With medical devices becoming increasingly sophisticated, they’re more likely to be damaged unless proper precautions are taken. RFID impact indicators alert teams to possible damage due to impact as well as track equipment in use, lowering the loss of due to misplaced or stolen devices.

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.

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.