Whitepapers

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.

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.

Here, we explain how results from DLS instruments at different wavelengths and scattering angles are related using practical examples and established light scattering theory

If you want to learn more about the physical characterization of your pharmaceutical powders, download this free e-book. You will find real measurement data that has been collected from a range of characterization methods, including particle, surface area and pore size analysis, powder rheology, and X-ray diffraction. Deepening your understanding of bulk particle properties is just the first step to get more predictable formulations and optimized processes.

Several parameters influence pharmaceutical powders. While research and development of drug formulation is highly dependent on material characteristics like purity and stability solubility, production deals with powder flow and packing and tableting processes. Furthermore, quality control ensures compliance and conducts elemental purity analysis. Understanding how to manage these parameters is the first step to optimizing your pharmaceutical powders and your final product

Any responsible business or industry takes quality seriously. It’s crucial to customer safety and satisfaction, and its prioritization in the development of healthcare products and services – especially pharmaceuticals – is obviously even more so. Nonetheless, it can be easy in development for smaller teams and companies to overlook some components of Quality, despite governmental requirements around complex quality initiatives. Those concerns are well-founded.

This infographic highlights variables for supply chain oversight and management for cell and gene therapies, which should be considered early - before the finished therapy is ready for patient administration.

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

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).

The overall success of an organization is driven by the team that makes it. Many seek to create a culture of continuous improvement, but the path to get there is not always clear. Empowering employees and involving them in key decisions is vital in achieving an environment of operational excellence and strong company culture.

The art of modified release dosage forms is highly specialized. The approach that Societal™ takes is one of thoughtful planning and execution.

It is no secret that Opioid abuse is an ongoing public health emergency. Societal™’s client stood at an impasse in pursuit of providing pain relief to patients, while following the recommendation of the FDA to reformulate the product for abuse deterrence.

Planning for CMC considerations early in the development process is key to the development process. If you have not properly planned your approach to these forms of documentation, you have opened your project to potentially detrimental delays.

Learn how Gibco™ Rapid Prototyping can accelerate your journey to cGMP

Learn how Gibco™ Rapid Prototyping can help idenitfy the most feasible cell culture media for cGMP scale-up.

This session will address ways to help streamline media manufacturing, including rapid, small-scale non-cGMP media prototyping and proprietary media formulation outsourcing options.

With so many outsourcing/insourcing options across drug development workflows, pharmaceutical companies are faced with finding the right partner to fit the needs of their unique molecule. There are criteria to consider when outweighing the benefits and risks associated with buying or building a bioanalytical lab.

Spatial bioanalysis is a unique solution that can help you quickly and efficiently generate quality and unique data to file an IND.

It’s crucial to follow strict guidelines for importing and exporting biological samples to ensure your drug discovery program’s timeline stays on track. Too often, mistakes are made that result in costly delays, handling mishaps and project rework.

The significance of oligonucleotides (OGNTs) in drug development is increasing rapidly, as they offer promising and life-changing treatments that can improve patients' lives. Within bioanalysis, there are five main approaches to consider, each of which has its advantages and disadvantages.

In bioanalysis, the future of small and large molecules offers exciting prospects for advancements in drug discovery, diagnostics, and therapeutics. With emerging technologies and larger substances, drug developers are faced with both new opportunities and challenges.

Mass spectrometry imaging (MSI) is beneficial in early development and murine models across many therapeutic areas. This technique is especially suited for oncology due to the availability of tissue.