Whitepapers

The update for EU annex 1 is more than a simple revision, solidifying the expectation that facility fully understand their processes and systems.  

This case study shows the results after implementing a continuous monitoring of product interface temperature, using a new non-invasive technique, during the lyophilization process.

This application note demonstrates how to develop a single method with direct detection of choline salts and impurities without the need for derivatization.

This application demonstrates the efficiency, throughput, and reliability of a dual injection system for finished pharmaceutical products and in-process APIs.

This whitepaper reveals strategies that create simple, stable formulations for your sterile injectable, a solid foundation for the entire life cycle of your product.

This whitepaper explores the drug repurposing, where known clinical candidates or commercially approved molecules are evaluated for new targets and indications.

Separation of 15 nitrosamines was achieved in under 14 minutes with LOQs <2 ng/g (ppb w/w) validated to ICH regulatory guidelines and easily meeting FDA LOQ requirements of 30 ppb.

This white paper addresses the key questions to ask as you evaluate prospective supply chain partners, especially in clinical cold chain distribution and storage.

In this study, the ability of the enteric coating to properly seal and protect capsule contents through various analytical tests was analyzed using dissolution vessels containing acidic media.

In the quality industry, how you choose to implement a quality management system (QMS) can have a big impact on your organization. Adopters are faced with a decision. Do you design a custom system from scratch or invest in purpose-built software? Our white paper “The Pros and Cons of Buying vs. Building a Quality Management System” explores the pros and cons of both options so you can make the best decision for your organization.

Multiparticulate systems have several advantages over conventional tablet or capsule formulations. Download this whitepaper to learn more.

Multiparticulate systems have several advantages over conventional tablet or capsule formulations. Download this whitepaper to learn more.

To bring lifesaving cell and gene therapies to the market, an efficient and scalable manufacturing strategy is needed. Find out more in this whitepaper.

Download this whitepaper to get a better understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.

This article exposes how CFD simulations can help us to face challenging designs involving fluid mechanics and thermal phenomena accurate study.

In pharma delivery, size matters. So, too, do the intricacies of dosage format, active ingredient compatibility, and effective delivery to patients—whatever their needs or preferences may be. Yet standard dosage forms haven’t always provided companies the options, flexibility, or performance to bring all those puzzle pieces together during therapeutic development. We spoke with Nathan H. Dormer, PhD, Director of Drug Product Development at Adare Pharma Solutions, to learn how this new technology platform is expanding the frontiers of therapeutic delivery and improving patients’ experience in the process.

This whitepaper explores vaccine development during a pandemic, a response to complex challenges that traditional manufacturing methods won’t solve.

As the industry—and the world—faces unprecedented challenges, your choice of CDMO plays an increasingly important role in the success of your project. New formulations and underserved patient populations demand a level of expertise many development and manufacturing partners simply don’t have. Is your CDMO partner able to adapt to today’s ever-changing world? Giovanni Ortenzi, the leader of Adare Pharma’s global pharmaceutical development and technical services, was recently interviewed about how Adare is uniquely qualified to meet and overcome these new challenges. Adare’s unique mix of expertise, innovation, and capacity makes us the perfect choice to bring your new project to market.

A variety of microencapsulation techniques are widely used in the pharmaceutical industry including fluid bed coating, spray drying, solvent evaporation, and more. However, one method—coacervation—offers several unique benefits to developers interested in working with challenging and/or bitter-tasting molecules, managing a product’s lifecycle, and accelerating development timelines. Learn how Adare’s Microcaps® taste masking technology platform, utilizes the coacervation process to solve your formulation challenges.

Discover why integrating Human Factors and patient activities from early device to manufacturing is essential to develop a patient-centric inhaler.

CPI, a CDMO specializing in Wurster fluid bed coating, has designed and optimized equipment based on linear scaling principles, creating ease and predictability to scale-up.