Whitepapers

Cell culture media is a foundational component of any biotherapeutic manufacturing workflow, crucial for maintaining cellular health and viability, maximizing titers, and supporting high product quality. As such, building a biotherapeutic manufacturing process with an optimized basal medium and feed system is vital to achieving optimal results and accelerating the speed-to-market of your product. However, the process of finding the most suitable basal medium and supplementation strategy can be challenging, as it requires balancing many key cell culture process variables to achieve specific technical goals within budget and time constraints. This guide will provide an insight into each development stage and offer best practices to help you achieve your project goals on time and within budget.

This whitepaper explores the criteria for defining true quality in a CDMO partnership, including multiple product, process, and relationship variables

With this white paper, explore how advanced lab informatics and digital tools can help unlock the potential of scientific data for business growth.

This application note demonstrates how Aura® systems can quickly and accurately characterize therapeutics for particles and product purity and stability.

Reaching sustainability and efficiency goals simultaneously is possible in RMID, a regulatory-enforced part of (bio)pharmaceutical drug manufacturing.

This technical overview discusses best handling practices for IVT mRNA and analysis with the Fragment Analyzer systems, including sample handling and quantification tips.

A two-step mAb purification process was developed, tested, and intensified. Increased process productivity, while exhibiting robust impurity clearance and high yield, was achieved.

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the industry. Technology to support their rapid growth must simplify and streamline processes during drug development.

To support the growing need for nitrosamine testing, SGS has expanded its volume for nitrosamine testing beyond its current service offering in Mississauga, Canada. SGS has added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) at its West Chester, PA and Markham, Canada laboratories to allow for expanded capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.

SGS has developed a network of centers of excellence for Nitrosamine testing across all regions to better serve our clients. Our experts specialize in method development solutions to identify and quantify all nitrosamine contaminants, including the challenging nitrosamine drug substance related impurities (NDSRIs).

This article provides an assessment of nitrosamine contamination specifically in biologics and contrasts the potential risks between these product types.

Discovery why evaluating a CMO’s internal processes, facilities, capacity, capabilities, and communication is key to successful ophthalmic scale up and manufacturing.

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.