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Pharmaceutical Manufacturing and Packing Sourcer

Levelling Up

The commercial benefits of continuous (as opposed to batch) manufacturing are well-documented. They include improved production efficiency, better capex and labour utilisation and enhanced product consistency. These benefits have already transformed the cost of production of many bulk commodities, simultaneously streamlining the associated supply chain. Those currently implementing continuous pharmaceutical manufacturing (CM) processes undoubtedly seek to realise these same gains, but perhaps the greater prize is the potential that CM offers to ease or even eliminate process scaleup. Taking a pharma process from the lab into commercial production within the prevailing regulatory environment is technically challenging, labour- and material-intensive and time-consuming. Streamlining the submission process and accelerating time to market are powerful drivers for change.

Understanding the Differences

Historically, the pharma industry has relied almost exclusively on sequential batch manufacturing processes. In this process, raw material is added at the start of the processing period, and product is discharged once a defined endpoint is reached. Material is neither added nor removed at any time, and in-process material is in a constant state of change. Conversely, in a continuous process, raw materials are continually added, product is continually discharged and the process operates. This last point is critical. Operation at a stable point makes it far easier to achieve high levels of product consistency and to manage and control the transition from one processing step to the next, facilitating the development of integrated processes.

A traditional batch tablet production process is shown in Figure 1. The product from each unit operation is tested postprocessing to ensure that the appropriate specification has been met, and then it is stored ahead of further processing. In contrast, with a well-controlled CM process, an integrated manufacturing train can potentially run from synthesis of the active pharmaceutical ingredient (API) through to tablet production, with minimal inventory or time delay between each processing step. Proceeding through development and submission to commercialisation with a CM process such as this is very different from analogous activities using a batch process.

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Alon Vaisman is Application Development Manager at Malvern Panalytical. Based at the companyís offices in Westborough, US, he supports pharma manufacturers worldwide in developing and improving their process operations through the use of in-process particle characterisation systems. Alonís background is in mechanical engineering, and he has over 15 years of applications and support experience. 

Martin Warman is Director of Martin Warman Consultancy, providing services to support QbD- and PAT-enabled control strategies for both batch and continuous manufacturing. He has over 20 yearsí experience working in the field, having previously led the PAT Development Team of Pfizer Global Manufacturing. He has also worked in academia, starting his career at the University of Westminster, UK, specialising in bioprocessing, and he has a bachelorís degree in cell biochemistry. Martin is also on the executive committee of ASTM E55, covering pharma manufacturing, and chairs the E55.01 sub-committee, covering PAT. 
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Alon Vaisman
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Martin Warman
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