news
Tecan launches new range of clear disposable tips
Tecan has introduced a selection of clear Liquid Handling (LiHa) disposable tips*, creating a one-stop shop for all your disposable tip needs...
List view / Grid view
Quality by Design (QbD)
article
Outsourcing: Current trends in the CDMO sector
Patheon’s Joe Principe examines current trends in outsourcing, highlighting the importance of investment in CDMO partnerships...
news
FDA approves cryopreserved formulation of ReNeuron’s candidate
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...
webinar
QbD applications for lipid-based pharmaceutical products
27 April 2017 | By Capsugel
In this webinar, Capsugel experts discussed the application of Quality by Design (QbD) to lipid-based formulations (LBF) and present case studies...
article
Pharmaceutical QbD: Omnipresence in the product development lifecycle
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’…
article
Understanding the effect of API changes in pharmaceutical processing
For the pharmaceutical scientist, the journey of an active molecule from the end of its synthetic pathway and crystallisation to its ultimate site of action is a fascinating one, and one that is necessary to understand...
article
Monitoring and controlling drug products and manufacturing processes with NIRS
Near-infrared spectroscopy (NIRS) is a rapid and non-destructive analytical technique that is important in analysing or profiling both solid and liquid dosage forms, as well as biotechnological products...
article
Quality by Design for generic products: opportunities and challenges
The first part of an in-depth article on Quality by Design (QbD), published in European Pharmaceutical Review in December 2016, focused on designing quality in to a pharmaceutical drug product by considering dosage form design, and understanding the importance of active pharmaceutical ingredients’ (APIs’) and excipients’ properties.
webinar
NIR Spectroscopy for Assessing Blend Uniformity in the Pharmaceutical Industry
21 February 2017 | By Viavi Solutions Inc.
This webinar presented the use of MicroNIR PAT for monitoring the endpoint of powder blending operations and discussed challenges that need to be addressed for successful implementation...
article
The Good, the Bad, and the Donald: what Pharma can expect from 2017
11 January 2017 | By Niamh Marriott, Digital Editor
From an orphan drug sales boom to uncharted political landscapes, the CPhI Worldwide expert panel predict pharma’s biggest opportunities and threats in 2017.
whitepaper
Application note: Implementing MicroNIR™ family of sensors for PAT/QbD applications
In this application note, Viavi discuss their MicroNIR family of spectrometers that are fully integrated and ultra-compact NIR sensors...
article
Quality by Design for generic products: opportunities and challenges
Quality by Design (QbD) precepts provide opportunities for enhancing efficiencies and reducing costs, especially for generic products. Over 80% of prescriptions dispensed in the United States in 2012 utilised generic dosage forms and it is unlikely that this proportion will increase to any extent because fewer innovative drugs are set…
whitepaper
Application note: Downstream biopharmaceutical operations
This Kaiser application note focuses on real-time, in situ process understanding using a Raman-based PAT approach. Raman spectroscopy is uniquely useful for biotechnology ‘Quality by Design’ (QbD) applications because it enables fast, non-destructive monitoring and control...
news
How & why to build a QbD process to optimise the efficiency of your freeze drying projects
Quality by design (QbD) for lyophilisation is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, not only by minimising risk but also through greater understanding of the process itself...
whitepaper
Application Note: MicroNIR PAT for blend monitoring
The aim of Quality by Design (QbD) is to build quality into a product and process from the outset. The pharmaceutical and related industries utilise powder blending operations to make solid dose drugs, yet the phenomena of powder mixing is the least understood of all sciences.
