Chemometrics - Articles and news items

Francisca Gouveia, 4Tune Engineering Ltd

Pharma development and manufacturing with QbD 2.0

Issue 3 2014, PAT & QbD / 3 July 2014 / José Menezes, Institute of Biotechnology and Bioenginerring, IST, Universidade de Lisboa / Francisca Gouveia and Pedro Felizardo, 4Tune Engineering Ltd

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…

Chemometrics: Implementing multivariate data analysis to monitor mammalian cell culture processes

Chemometrics: Implementing multivariate data analysis to monitor mammalian cell culture processes

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.


Intelligent Process Condition Monitoring for industrial tablet coating operation

Issue 6 2012, PAT & QbD / 18 December 2012 / Jun Huang, Saly Romero-Torres, Liam Ryan and Mojgan Moshgbar, Pfizer Inc

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.

Implementing chemometrics in late stage development and manufacturing

Implementing chemometrics in late stage development and manufacturing

Issue 2 2012, PAT & QbD / 26 April 2012 / Geir Rune Flåten, former Chemometrician Leader in Global Manufacturing and Supply at GlaxoSmithKline

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.


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