26
August/September 2010
From crude samples to highly
pure isolated solids in 4 hours Delivery of pure, dry, free flowing solids by a customer focused, medicinal chemistry purification service, using a Lean Sigma approach
by Peter Barton, Scott Boyd, Steve Chapman, Clive Green, Sam Groombridge, Adele Loynes* & Paul Whittamore Cardiovascular & Gastrointestinal Chemistry, AstraZeneca Pharmaceuticals, Mereside, Alderley Park, Macclesfield, Cheshire, SK10 4TF UK Corresponding Author:
adele.loynes@astrazeneca.com General Information:
www.astrazeneca.com
Over the past few years the concept and benefit of Lean Sigma has become increasingly valued within the pharmaceutical industry. The necessity to drive efficiency and streamline processes is critical to the delivery of compounds through the R&D process in the most effective ways. Aiding the reduction of turnaround times and costs for a purification service, whilst retaining the quality of compound delivered highlights the value of customer insight and collaborative working. Approaching an improvement project in this way ensures the implementation of the most effective and appropriate improvement strategies.
Introduction As pharmaceutical companies continually strive to reduce the time and cost of bringing a new drug to market, the efficiency of each phase in the Drug Discovery/Development cycle becomes even more critical. With specific reference to early stage Discovery, numerous compounds are synthesised in design sets, with the intention of improving overall properties to develop these compounds as pharmaceutical agents. Naturally, collaborative working between scientific disciplines is crucial to progressing projects through into Development and the need to maintain efficiency of these individual processes is vital. At AstraZeneca, ensuring efficiency throughout the design, make, test cycle (DMT) has been achieved through streamlining processes within each discipline and aligning their functions to enable parallel testing.1
Routinely, primary
biological assays are now scheduled on a weekly basis to enable advanced planning and focus for the Department. This weekly planning system places an emphasis on Chemistry to deliver compounds by Friday each week to maintain the flow and efficiency required for projects to reach milestones and progress forward.
Obviously, with the increase in demand on Chemistry it becomes vital for each component of the synthetic process to run in the most efficient manner. Consequently, Synthesis has adopted visual planning boards as a tool for tracking Work In Progress, allowing continual project discussion and forward planning. However, it is recognised that the efficiency of compound delivery through the Chemistry Section relies on the success and turnaround times for purification. The inclusion of a purification service within the department has allowed individual dedication to both of these specialist areas. As a result, the demand on a purification service to deliver pure, solid compounds in line with specific customer expectations became challenging. This was heavily influenced by the discrepancy between the turnaround time achievable within a multi sample purification service and the expectation of the synthetic customer. Consequently, the service provided to customers failed to meet expectations, impacting efficiency parameters through lengthy turnaround, delaying the flow of samples. This indicates the need to critically investigate the purification process in relation to turnaround time to help improve efficiency of the DMT cycle.
Discussion Addressing the above concerns was possible using a Lean Sigma approach through working with the key fundamental concepts to facilitate the improvement in quality and speed at which processes can deliver.2
The
two most crucial aspects specific to the nature of this project were to outline and understand the purification process, specifically its individual steps and establish the key requirements of immediate customers. Creating a framework for understanding the flow of compounds through a process can be illustrated with a SIPOC diagram (Figure 1), detailing the input required from suppliers, process steps and the output delivered to the customer. 3
In addition, understanding what the customer believed to be critical to quality in terms of the level of service they receive can easily be captured using Voice Of the Customer (VOC) questionnaires.4
These assessments were made
during face to face 1:1 discussions with the individual customers, in this case the synthetic chemistry community. The main requirements asked for were to ensure delivery of pure, free flowing solids within a guaranteed consistent delivery time. Further clarification highlighted the need to concentrate on routinely providing
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