Whitepapers

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.

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.

Drug developers face pressure to accelerate clinical trials to reduce costs while addressing unmet medical needs. In this Tech Talk video series, PPD’s scientists share how to improve clinical trials while the biopharmaceutical sector continues to face major headwinds. In the final video in the series, John Maier, director CDM, PPD® Laboratory services, and Renay Perry, senior director, project management, review how technology and real-time data integration can improve the clinical trial experience and outcomes.

Pharma and biotech companies strive to accelerate clinical trials to reduce their costs while continuing to meet unmet medical needs. In this Tech Talk video series, PPD’s industry scientists share improvements to clinical trials using innovative data solutions and technological advancements within the central lab.In the 2nd video of the series, Chris Clendening, SVP, lab operations, PPD® Laboratory services, and Tim Rich, VP, PPD Digital and Decentralized solutions, discuss the importance of direct-to-patient and direct-from-patient shipments as it pertains to the intersection of decentralized clinical trials (DCTs).

Drug developers face pressure to accelerate clinical trials to reduce costs while meeting unmet medical needs. In this video series, PPD’s industry scientists share how to improve clinical trials using innovative data solutions within the central lab, real-time data integration, technology and advancements in decentralized clinical trials (DCTs).The first video of the series has Olivia Aspite, executive director, PPD® Laboratory services, and Bryan Neth, manager, business analytics, PPD Laboratory services, discussing how the Phase III COVID-19 vaccine study provided a case study for how to improve clinical trial using innovative solutions.

This whitepaper describes how hot melt extrusion (HME) and a specially-engineered grade of polyvinyl alcohol (Parteck® MXP polyvinyl alcohol 3-82 Emprove® Essential Ph Eur; referred to in this publication as Parteck® MXP 3-82 PVA) can be used to increase the solubility of DCS IIb molecules.