Whitepapers

There has been a Growing concern among regulators driving a need for awareness for manufacturers to understand the risk associated with nitrosamines in pharmaceutical and biopharmaceutical products. In this session of Changing the Conversation with SGS Live, we tackled a variety of aspects of this important issue from the risk associated with nitrosamine contamination to discovery and mitigation of nitrosamine impurities. Our experts shared the current testing requirements, along with how SGS is helping drug manufacturers along the path of development to ensure their products are free from nitrosamine contamination.

Rapid sample analysis using AEMS technology improves bioanalytical study turnaround

In this study, HEK293F cells grown in scale-X bioreactor produce >3x higher AAV-2 vector, with 25-52% lower cost than the reference process.

End-to-End Workflow Solutions for Oligonucleotide Analysis - From research discovery to production QA/QC

This short video provides an overview of a complete, end-to-end oligonucleotide workflow solutions

In this application note, LC separation and MS1 mass identification of a variety of oligos without the use of ion‑pairing reagents is demonstrated. The LC separation allows subsequent positive mode use with little to no flushing or hardware changes. This HILIC-based method uses an Agilent InfintyLab Poroshell 120 HILIC-Z column and MS-friendly ammonium acetate-based mobile phases. The samples were analyzed on an Agilent 1290 Infinity II LC system and a 6545XT AdvanceBio quadrupole time-of-flight mass spectrometer (LC/Q-TOF).

Characterization of oligonucleotides requires robust analytical instrumentation and methods as well as ease-of-use data analysis tools. Biocompatibility mitigates non-specific sample binding to flow path and it ensures the integrity of biomolecules and robustness of the system. In this study, two workflows, the Target Plus Impurities (TPI) and Sequence Confirmation workflows in Agilent MassHunter BioConfirm software, were carried out to characterize two oligonucleotide samples.

In this application note, the determination of oligo sequence confirmation using HILIC LC and high-resolution MS/MS data is described. As with the previous studies, an InfinityLab Poroshell 120 HILIC-Z column was used along with an Agilent 6545XT AdvanceBio LC/Q-TOF mass spectrometer.

UV-Vis spectrophotometers have been used widely for nucleic acid quantification and quality control (QC) utilizing the fact that nucleic acids have a maximum absorbance at 260 nm (1). The concentration of nucleic acids can be easily estimated using the absorbance at 260 nm and the established absorption coefficient. Often a background correction is also performed, for example collecting a baseline using a solution containing everything but the nucleic acid or by measuring the absorbance at a wavelength that nucleic acids do not absorb. Double stranded nucleic acids are bound by hydrogen bonds between the base pairs. The temperature at which double stranded nucleic acids denature to become single stranded depends on the: – sequence and length of the nucleic acid – the pH and buffer conditions – and any mismatches in base pairs between the two strands As such, the melting temperature is very useful analytical tool and can be studied by monitoring the absorbance at 260 nm as temperature is increased or decreased. As the temperature is increased, the hydrogen bonds between the strands are broken and the double stranded nucleic acid separates into two

This customer note demonstrates the implementation of native SEC-MS using the Vanquish Duo UHPLC system.

Analytical techniques are crucial to protein biotherapeutics research, development, and manufacturing. It is important to understand diverse particle characterization techniques and how they relate to each other to ensure the safety and efficacy of drug products.

With advances in the technologies used in LC-MS-based proteomics workflows, sensitive, reproducible, and efficient single-cell proteomics is now possible. Learn about these advances and how they work in concert to maximize the combination of protein and peptide identifications and sample throughput.

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.