Whitepapers

Learn how enzymatic chemistry increases conversion efficiency for higher yields with fewer by-products, and what to look for in an API CDMO partner for biocatalysis.

To stay competitive, pharma companies must avoid quality failures. This brief examines 6 quality & compliance mistakes & actions to help mitigate effects.

This white paper from Ascendia Pharma details four factors to consider when selecting a CDMO for your next drug development project.

Terminal sterilization of aseptically processed drug products is extremely important for patient safety. As such, it is a regulatory requirement that drug products that can withstand terminal sterilization be terminally sterilized. Overkill type sterilization cycles are not required for a drug manufacturer to make a terminal sterilization claim. Many different time and temperature combinations that are much more product friendly can be used to safely terminally sterilize drug products.

Cationic Adsorbent Gel Raft formulation for use in proton pump inhibited stomach.   Concept proven with fiberoptic UV probes eliminating the need for HPLC analysis. 

This whitepaper deals with the sterilization of prefilled syringes and describes which requirements must be considered regarding products and methods as well as how risks can be avoided effectively.

Delivery of robust E&L programs by leveraging Agile software development methodologies in the laboratory.

This case study highlights the benefits of a pre-fabricated modular construction approach using autonomous cleanrooms in support of the accelerated delivery of a COVID vaccine manufacturing facility.

In the highly regulated life sciences industry, effective change control is essential to your success. Our white paper “Managing change Control to Comply With FDA and EU Regulations” will show you how you can improve change control speed, efficiency, and compliance.

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.