Whitepapers

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

A rapid, continuous, lower-cost, scalable, yet challenging process, spray drying in the hands of an experienced CDMO can improve solubility and bioavailability of APIs.

A lack of quality can cost an organization millions of dollars in rework, scrap, recall, or even liability lawsuits. This industry brief shows how a quality management system (QMS) with the right characteristics can help a company avoid quality roadblocks and form the foundation for long-term regulatory compliance and, ultimately, for ensuring market success.

Many details must be considered to maintain a successful disinfection program. These details can make a big difference in a critical environment.

This paper explores the most important data challenges experienced by the rapidly modernizing pharmaceutical industry and proposes a GxP-compliant, ready-made application as a solution designed to increase efficiency in upstream processes, while maintaining data integrity and compliance.

Ask these five questions to find a smart CDMO partner for your projects. Probe strategically to experience fewer manufacturing issues, faster approval, and higher ROI.

This tech note evaluates intra- and inter-system retention time and peak area precision for the analysis of two active pharmaceutical ingredients and their related impurities

Ask these five questions to find a smart CDMO partner for your projects. Probe strategically to experience fewer manufacturing issues, faster approval, and higher ROI.

After a disruptive year in the pharma industry, it’s time to adapt to the next normal. Learn about the four main trends shaping the evolving industry.

This note describes a rapid method for the evaluation of sediment redispersibility in less than 30 minutes using the Turbiscan technology.

Changes to the EU Good Manufacturing Practice for the Manufacture of Sterile Medicinal Products are coming. Annex 1 is being updated how will it affect you?

This infographic depicts various custom packaging solutions for tracking, security and brand protection in the war against counterfeit products and theft.

This paper explores the most important data challenges experienced by the rapidly modernizing pharmaceutical industry and proposes a GxP-compliant, ready-made application as a solution designed to increase efficiency in upstream processes, while maintaining data integrity and compliance.

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.