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- Contract Research, Clinical Trials and Outsourcing
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Chemometrics - Articles and news items
Pharma and BioPharma industries are aware of the impact of production processes on sustainability of business operations. To improve performance, companies have recognised that it is necessary to better understand the drivers of both costs and revenues and the actions that can be put in place to address them. In the past, commercial manufacturing emphasis was on full compliance with initially established product specifications leading to a perception of quality assurance based on testing, and avoiding later changes after regulatory submission. Although final product testing is an important element of quality control, final product quality can be measured but not modified, leading to product rejection or reprocessing activities and underperforming business outcomes, two kinds of waste according to lean manufacturing…
Issue 3 2013, PAT & QbD / 13 June 2013 / Payal Roychoudhury, formerly AstraZeneca and Ronan O’Kennedy, Fujifilm Diosynth Biotechologies and Jim Faulkner, GlaxoSmithKline and Brian McNeil & Linda M. Harvey University of Strathclyde
Biopharmaceutical companies are constantly evaluating new methods for mammalian cell line development that offer benefits such as shorter time lines, improved consistency, higher monoclonal antibody (mAb) production, better genetic stability and increased flexibility. Each of these advantages extends a potentially large cost benefit to companies as their recombinant protein products move from development into the clinic, and finally on to commercial launch. In this context, sophisticated chemometric software packages show great potential in enhancing process knowledge and providing optimised control of these complex and challenging processes.
This paper presents a feasibility study to develop an Intelligent Process Condition Monitoring (IPCM) system for providing a real time ‘health check’ for the tablet coating process in drug product manufacturing. The study fits well under the framework of Intelligent based Manufacturing (IbM) initiated at Pfizer, and intends to move the coating operation from responsive and reactive action to preventive and proactive strategies in ensuring process performance and product quality attributes. The successful implementation will ultimately improve batch yields and reduce coating interruptions.
Complex coating in a controlled-release tablet process is a critical unit operation used to control dissolution and a number of other product quality attributes of some tablets. The variation in coating process and equipment performance, especially sensor/equipment failures, poses a major risk to process outcomes and product quality.
The proposed multivariate condition monitoring system is expected to achieve the following: 1) Real-time monitoring of batch coating evolution and performance; 2) Immediate fault detection and diagnosis, e.g. process deviation or sensor failure; and 3) Enable preventive or corrective actions in conjunction with control systems.
Chemometrics was defined as a research area in 1974 and developed rapidly through the following decades in parallel with the fast paced improvement in analytical technologies and computational power for lab instruments and sensors. Chemometrics is essentially the translation of measured signals characterising a sample or a process into meaningful results. This is achieved by applying a number of powerful multivariate data analytical techniques (MVA) to develop a model from a representative data set, and use this model to predict or quantify the property of interest for new samples or process runs.
In the pharmaceutical industry, chemometrics has been successfully applied at every stage from discovery, through development, and to manufacturing. In this review, the requirements and benefits to applying chemometrics in late stage development and manufacturing will be discussed.
Two main areas of interest in pharma – ceutical development and manufacturing are QbD (Quality by Design) and PAT (Process Analytical Technologies), and chemometrics, i.e. modelling, is a key element of these approaches. Chemometrics is used for simplicity as the label for any model translating data into meaningful output in the following discussion. To maximise the benefit from chemometrics, the very first step is to define the objective of the model.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific ReAgent Russell Finex Limited Sentronic GmbH Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited WITec GmbH Xylem Analytics YMC Europe GmbH Yusen Logistics