Whitepapers

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.

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.

Process equipment used in the healthcare and pharmaceutical industries follow rigid specifications for accuracy, consistency and cleanliness.

Successfully develop and commercialize new medicines with a highly accomplished collaborator.

How to achieve robust and consistent high-quality productivity for successful commercial manufacturing is dependent on clearly defining your criteria for successful scale-up. This article explains how using a fully optimized cell culture medium, and identifying it early in the development process, should be part of the criteria as they can avoid time-consuming and costly redevelopment at scale-up.

Counterfeiting has a profound effect on drug manufacturing and the role your secondary packaging suppliers play in ensuring compliance.

This brochure presents Gibco™ products and dedicated support services backed by a robust global manufacturing network to help you scale up your AAV manufacturing workflow with confidence and meet your project goals

Unlock the full potential of your pharma/biopharma laboratory with our comprehensive guide on mastering liquid handling techniques for any liquid type.

As processes increase in scale, the greater raw material volumes and stricter quality requirements can make it challenging to deliver an effective and economically feasible product. In this how-to guide, we discuss the common challenges that developers face when moving through process development and outline the essential steps for streamlining scale-up through effective raw material sourcing.

Although the potential of gene therapy has been established for decades, it is only in recent years that the industry has seen a major turning point with the first therapies receiving approval in the late 2010s. As the potential of these therapies is realized, the question of the hour is: how do we manufacture AAV gene therapies sustainably in the long term?

Compendia publications are periodically updated in order to align with industry trends and harmonize with global regulatory practices. Staying abreast of these changes well before they are implemented, and being ready to adapt as necessary, is in the best interest of any bio/pharmaceutical testing laboratory. Eurofins BioPharma Product Testing has proactively adjusted its procedures, collaborating with stakeholders and providing feedback to ensure smooth integration and minimal impact on existing testing methods.

Across our network of companies globally and regionally in North America, Eurofins has made a significant amount of progress related to our Environmental, Social and Governance initiatives. At Eurofins, we believe that sustainability is at the heart of what we do. We are guided by our vision to be the global leader in Testing for Life, our mission of contributing to a healthier and safer world, and our core values that provide a strong foundation towards Environmental, Social and Governance (ESG) initiatives.

Eurofins BioPharma Product Testing offers comprehensive testing capabilities to ensure our clients’ drug products are supported throughout the development process to commercial release. Our Viral Clearance Services team provides fully cGMP-compliant services from research and development assessments through manufacturing, clinical trials, and filing for Biological License Application (BLA). Our staff is experienced with varied perspectives from the research, process development, and manufacturing sectors.

Eurofins BioPharma Product Testing acquired ENCO Pharmaceutical Development in the fall of 2022 after more than two decades of operation as an independent contract service provider. The acquisition expanded Eurofins BPT’s presence in the southeast United States and brought a significant amount of experience in three key areas: ophthalmic, medical device and animal health. Now renamed as Eurofins BioPharma Product Testing ENCO, we stand ready to serve in an even greater capacity, with expanded service offerings at both the former ENCO sites as well as connecting with added service.

Microbial challenge studies are non-compendial studies that evaluate the microbial growth potential of a product to determine safe holding time, storage conditions, and effectiveness of preservatives. These studies are often performed on sterile, non-preserved drug products that are prepared and/or penetrated for the purpose of final product preparation and are often held for a period of time before administration to the patient.