Whitepapers

This white paper discusses developing optimal platform analytical methods with partner CDMOs for effective process impurities clearance in biological drug substances.

Companies looking to implement a quality management system (QMS) are faced with a dilemma: They can design a custom system from scratch or invest in purpose-built software. Before you decide which kind of QMS is the best fit for your needs, learn the pros and cons of each.

This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.

The analysis of tissue samples as a typical application of FTIR microscopy in biology to identify diseased or damaged tissue. It has typically been limited in use for research purposes due to the large amount of time needed to obtain the spectral data. The new HYPERION II significantly reduces the time to collect data and can be utilized for endless applications.

Nano PharmaSolutions developed a new nanoformulation for improving solubility of drug molecules, which can save several months of preclinical stage of drug development.

Topical drug formulations often require more excipients to deliver their API payload effectively. Therefore, excipient choices impact manufacturing & commercial success.

This application note shows how Sievers TOC analyzers and common sensors in the industry recover 11 different compounds most often used in water and product analysis.

This application note demonstrates how Renishaw’s inVia™ Raman microscope is the ideal system for chemical characterization.

The teams at Fagron have found a way to improve right-first-time metrics by 100%. How are they doing it? Read our case study to learn more.

This article outlines the journey of understanding data and its exploitation in the field of preventive and predictive maintenance. Based on a non-intrusive approach.

This compendium offers a resource to help tackle the common instrument challenges faced during method transfers to obtain consistent results and sustain regulatory compliance.

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

This application note demonstrates the importance of maintaining strict quality control of pharmaceuticals - from raw and packaging materials to intermediate and final products that are completely free of contaminants.

This application note demonstrates how Renishaw’s inVia™ Raman microscope is the ideal system for chemical characterization.

Advanced analytics can extract enormous value from your LIMS. Find out how LabVantage Analytics solves the challenges of data access, visibility, volume, and speed for complete data views and endless insights.

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.

The diversity & agility of API supply chains is key to ensuring that medicines can be manufactured & delivered to patients; this Ebook explores the path to a secure supply chain.

Don’t let do-it-yourself efforts at API supply cut into your bottom line, limit your velocity, and introduce risk into your supply chain. Learn five reasons to outsource procurement of your APIs.

Therapeutic proteins have been explored for their use in cancer treatment, autoimmune disease, and other difficult-to-treat conditions. But, their stability is critical for patient safety and efficacy. This ebook on FTIR/NIR/Raman in Bio/Pharmaceutical Analysis discusses some common techniques used for evaluated the physical stability and activity of biologics.