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Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
Regulatory expectations nowadays focus on harmonisation of global regulations. This whitepaper by PQE looks at current and emerging trends in regulatory expectations.
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.
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...
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.…
Luminata enables assembly of a complete impurity control strategy for pharmaceutical development...
Bioprocesses require automated process control to make quality products consistently and efficiently...
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
Provides Drug Manufacturers with Extensive Test Results for Tubing Comparison...
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...
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…
This In-Depth Focus looks at QbD and PAT for cutting biopharma attrition rates as well as continuous freeze-drying technology for biopharma products...
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…
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.
