whitepaper
Whitepaper: Emerging trends in regulatory expectations
Regulatory expectations nowadays focus on harmonisation of global regulations. This whitepaper by PQE looks at current and emerging trends in regulatory expectations.
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Quality by Design (QbD)
webinar
Applying quality risk management to develop an isolator filling line
11 February 2019 | By Particle Measuring Systems
Following the patent of the "Espresso" innovative infusion device, the Italian Biochemical Institute (IBI) "Lorenzini" commissioned Comecer to construct a new isolated filling line.
news
Pharmapack report predicts diversification of innovation leading to a rise in licensing and partnering
Pharmapack Europe has released a ‘European drug delivery and packaging’ report, ahead of the event’s opening which highlights, major challenges and opportunities for the industry in the year ahead...
article
The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying
Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials.…
product
Anne Marie details the benefits of ACD/Labs’ Luminata
Luminata enables assembly of a complete impurity control strategy for pharmaceutical development...
whitepaper
Scientific Poster: Raman spectroscopy technologies enabling scalable process control in bioprocessing
Bioprocesses require automated process control to make quality products consistently and efficiently...
article
Raman In-Depth Focus 2018
In this issue: the applications of vibrational spectroscopy for analysing the molecular component of a solid sample, and Raman as a fast-growing tool for PAT/QbD
news
AdvantaPure® completes full BPOG extractables testing of several silicone and TPE tubing products
Provides Drug Manufacturers with Extensive Test Results for Tubing Comparison...
news
Siemens and Perceptive Engineering combining software solutions for the pharmaceutical industry
Siemens AG and Perceptive Engineering Ltd announce a partnership which offers Perceptive’s PharmaMV and Siemens Simatic Sipat software products closely integrated to provide a versatile solution for advanced control and optimisation applications in both continuous and batch pharmaceutical manufacturing...
article
Quality by design and single-use air sampling
Quality by Design (QbD) is a method approach to developing a quality control system using predetermined objectives. It uses the foundations of risk management and science to ensure a repeatable process to manufacture high-quality products. In 2002, the FDA launched QbD as part of its innovation initiative. This paper outlines…
article
Biopharmaceutical Development & Processing
This In-Depth Focus looks at QbD and PAT for cutting biopharma attrition rates as well as continuous freeze-drying technology for biopharma products...
article
What do we need from PAT?
Pharmaceutical manufacturing in the modern era is facing unprecedented demands, including in-depth scrutiny of production methodology, and inefficiencies in current practices with respect to waste, energy usage and time management. Coupling this with increased complexity in the manufacture of newer products and the decline of blockbuster drugs, results in an…
article
The importance of critical quality attributes in Quality by Design for rapid bioprocess development strategies
QbD and PAT could revolutionise the way biopharma industries operate by cutting down their attrition rates, which could drastically change their business model. This article considers the issues involved.
news
How good design improves energy efficiency
In April 2018, changes to energy efficiency regulations will mean that every non-domestic privately rented property must have an EPC rating of at least an E. Here, John Rush, discusses three tips for improving the energy efficiency of HVAC systems in laboratories...
article
Issue #5 2017 – Digital Version
In this issue: Sample preparation - is it possible to have too much? Developing successful over-the-counter syrup packaging for the highly regulated EU market. In-line process PAT in continous wet granulation, and much more...
