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During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…
The regulatory environment has a great impact on business, especially in healthcare. Non-compliance exposes companies to the risk of launch delay, delisting products from the market and out-of-stocks. Moreover, it can cause reputational damage affecting staff, consumer and shareholder confidence, reduce market opportunities, and affect the bottom line.
This article reviews the trends in freeze drying highlighted at recent Parenteral Drug Association (PDA) conferences...
When reviewing the range of activities required to deliver pharmaceutical products of the required high quality within a strict regulatory framework, an organisation will identify services, which while still business critical, are considered as non-core to the mission of the organisation. These non-core services still need to be delivered, either…
Developmental activities for freeze-dried products are dictated by the limited availability and high cost of newly developed active compounds, and by Quality-by-Design requirements. Laboratory-scale freeze dryers used for formulation and process development show an excessive variety of designs and instrumentation concepts, making scale-up activities a challenge. The development of miniaturised…
A thorough understanding and control of extractables and leachables in liquid and semi-solid products has long been a regulatory requirement.1,2 Regulatory guidelines require that product contact surfaces are “not reactive, additive or absorptive”.3
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
Scale-up and manufacturing strategy for insect cell culture (ICC) should be assessed at the earliest stages of process development. Your final goals will shape the process and determine at what stage to implement steps that can make the process more reliable and robust at manufacturing scale. Sharyn Farnsworth, Associate Principal…
Bringing a biosimilar from early development to market is a risky endeavour say Magnus Franzen (left) and Chris Isler, biosimilar experts at PA Consulting Group...
An exclusive column from the ABPI's Magda Papadaki about the implications of synthetic biology for the pharmaceutical industry...
Consistent with quality-by-design (QbD), and driven by the desire for continuous manufacture and real-time lot release, biopharmaceutical manufacturers require advanced process analytical technologies (PAT) for process monitoring and rapid analytical information generation.
An effective environmental monitoring programme is designed to estimate the microbial content of the room’s air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment.
Veeva's Rik Van Mol explains how streamlining the clinical process will not only improve the speed but also the quality of the data...
David Edwards explains how Agilent spectroscopy systems combine core qualities of robustness and reliability with a spirit of innovation.
Global Heat Transfer's MD, Clive Jones, gives 3 considerations for manufacturers operating thermal fluid heat transfer systems to safeguard the system’s future for the long term.
