Whitepapers

Process development methods & analytical requirements are integral parts of gene therapy manufacturing. This whitepaper explores the analytical and development approaches needed for success.

Creating a new therapeutic drug can take a decade or more to get to patients. Antibody production and discovery play an integral role in setting the stage for success at later stages of development. If a high affinity, functional antibody candidate is discovered early, the timeline to a finished targeted and effective therapeutic drug may be significantly reduced. In this podcast we will go through the untold tales of antibody production and discovery, as well as how Twist has optimized a process for antibody production and screening for potential therapeutics.

While continuous bioprocessing has been around for decades, it is becoming more attractive as technological advances and new trends in the biopharma industry emerge.

Quality management is inherently complex. That’s why you need QMS software that’s suited to your company’s unique needs. This comprehensive resource shows you the key quality management software features to look for and ways modern tools can give you an edge today while paving the way for success tomorrow. Wherever you are on your buyer journey, the foundation provided in this guide will help you make the right choice.

Connected applications, advanced analytics, and AI have become essential tools as the pharma industry intensifies focus on data. Learn how to go beyond proactive quality management by tapping into your data’s hidden intelligence. Get your guide.

This application notes demonstrates the long-term reproducibility and performance of the SCIEX 7500 system with challenging matrices..

Transferring from a conventional batch mode to a multi-column chromatography (MCC) process significantly increases the productivity of the Fab fragment capture.

Time to results can be significantly reduced with the use of RapidFire high-throughput mass spectrometry (MS). With this technique, a lab’s next great innovation can be brought from conception to reality in a timely and efficient manner.

Air and oxygen bubbles in bioreactors and fermentation vessels can cause substantial noise on signals from dissolved oxygen sensors, leading to a significant negative impact on processes. In this white paper, we examine a unique solution that eliminates DO sensor signal noise and outline a case study on the solution’s implementation.

Digital measurements provide real-time sensor health diagnostics, improve measurement reliability and enhance process control capabilities. Get the guide to see 5 specific ways that digital sensors improve bioprocessing.

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.