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The rapid increase in demand for biopharmaceuticals presents manufacturers with unique challenges to ensure quality and regulatory compliance while maintaining supply and production capacity.
JRS Pharma is a leading manufacturer of excipients, offering a complete portfolio of excipient solutions for the pharmaceutical and nutraceutical industries...
PROSOLV® SMCC, silicified microcrystalline cellulose, is a unique combination of microcrystalline cellulose (MCC) and colloidal silicon dioxide (CSD)...
6 June 2018 | By Abbott Informatics
In this webinar, we’ll introduce you to laboratory information management systems (LIMS) and demonstrate how this software can help you achieve regulatory compliance, quality data management throughout your product’s lifecycle...
Butterworth Laboratories provides analytical chemistry services to the global pharmaceutical and related industries. Established over 40 years ago, the company specialises in raw materials analysis and regularly supports seven of the top 10 global pharmaceutical companies by sales.
In this guide to ingredients, two leading companies involved in testing and analysis explain how their service offering meets current industry needs...
A report released has identified a two-tier manufacturing market and forecast increased acquisitions by Indian companies...
Novel optical technology ensures repeatable sample analysis results...
In this application note, HORIBA discuss using raman spectroscopy to study the distribution of compounds in pharmaceutical drug products...
In this infographic, the Royal Pharmaceutical Society offers a more complete picture from excipient experts...
The concept of Quality by Design (QbD) was implemented by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and United States Food and Drug Administration (FDA) around a decade ago, with the aim of adopting systematic approaches for developing high-quality pharmaceutical products for patients’…
The ability to predict multiple constituents of a final dosage form in one fast, non-destructive measurement can reduce analysis time. This is especially important when quantification of multiple APIs is required for tests such as content uniformity, assay and ID...
In this Ingredients In-Depth Focus: Excipient quality and supplier interchangeability; Interpreting ICH’s evolving residual solvents guideline; Q&A with Meggle...
22 October 2015 | By Iain Moore, President, EXCiPACT asbl
There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…
22 October 2015 | By Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen
Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins…
