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What is process characterization?What is process characterization?HighlightsIntroduction What is processcharacterization forbiological drugs?Process characterization is an essential step in thecommercialization of a new (biological-) drug. For drugproduct commercialization, manufacturers must validate the Which regulatoryguidance is available?drug’s manufacturing process. This ensures, that the Goals & timing withinthe product lifecycle?product and that the patient is not at risk.manufacturing process delivers consistently a quality Role of datamanagement &statistics in processcharacterizationstudies.Process Validation is defined as the collection andevaluation of data, from the process design stagethroughout production, which establishes scientificevidence that a process is capable of consistentlydelivering quality product.FDA process validation guidelineContactEXPUTEC GmbHMariahilferstr. 147/2/2D1150 ViennaAustriawww.exputec.comM: contact@exputec.comT: 43-(0)1-997 28 49Recently, US and European regulators have issued newprocess validation guidelines. The new guidelines nowemphasize: the demonstration of process understanding; risk-based identification of critical process parameters; implementation of well-validated control strategies;EXPUTEC GmbH www.exputec.com 43-(0)1-997 28 49 contact@exputec.com 2017. All rights reserved.1
What is process characterization?As a result of the new guidelines, it is nowReason 2: Avoid registration delays. A delaystate of the art that drug manufacturersin the commercialization of a product hasthoroughly investigate and “characterize”negative impact on patients: They have nothe manufacturing processes. Interestingly,access to a drug they can benefit from.the term “process characterization” is notFurthermore, a delay in the commer-used by the regulators. You will not find it incialization costs money:the EMAs and FDAs process validationguidelines.Yet,CMOsand(bio-)Costly registration delays resultingfrom poorly understood processesand failed validation batches can costa company tens of millions of dollars.pharmaceutical companies use the term“process characterization” to describe theiractivities related to stage 1 processJames E. Seely, Ph.D., Robert J. SeelyA Rational, Step-Wise Approach toProcess Characterizationvalidation.Process characterization is howindustry puts stage 1 processvalidation into practice.Reason 3: Avoid failed uring cost companies millions ofdollars. A thoroughly characterized processwith the right control strategy in placeavoids deviations and failed batches incommercial manufacturing.Goals of process characterization studies?Why do manufacturers run process identify process parameters that impactproduct quality and yield;characterization studies? and acceptance criteria;Reason 1: Achieve compliance. Ultimately,the product should reach the patient. Tojustify manufacturing operating ranges identify interactions between processachieve this, manufacturers must ss.Processcharacterization is an integral part of stage1 process validation. andcriticalqualityensure that the process delivers aproduct with reproducible yields andpurity.EXPUTEC GmbH www.exputec.com 43-(0)1-997 28 49 contact@exputec.com 2017. All rights reserved.2
What is process characterization?Do I need to include data from commercialStatisticaldataanalysisscale in my process characterizationcharacterization studiesforprocessstudy?Statistical data analysis plays acritical role in processcharacterization studies.Yes, because you need to qualify your scaledownmodel.Scale-downmodelqualification is an integral part of processcharacterization studies. To perform a scaleBiotech companies address the followingdown model qualification, commercial scalequestions using statistical data analysis fordata (at set point conditions) is necessary.successful process characterizations:More information can be found in our article“What is a bioprocess scale down model?“. risk assessments (e.g. how to supportfailure mode and effect analysis)?When to start a process characterizationstudy?How do I use available data to support How do I statistically demonstrate thatmy scale down model is appropriate?According to our consulting experience, process characterization studies take atleast 12 months for completion. Hence, toWhich response variables should bestudied in an experimental design? How many experiments do I need tobe ready before license application (andconduct to proof a potential criticalhave a time buffer), it is best practice to startparameter not critical?a minimum of 16 month before the planned How do I state statistically that alicensure. Biotech companies typically startparameter is key, non-key, critical orprocess characterization activities once itnon-critical?becomes very likely that the product will go How do I statistically define normalto market, which is after successfuloperatingcompletion of phase two clinical trials.ranges? andprovenacceptableHow do I stack together multiple DoEsto identify optimization potential andpredict out of specification (OOS)events?EXPUTEC GmbH www.exputec.com 43-(0)1-997 28 49 contact@exputec.com 2017. All rights reserved.3
What is process characterization?Data management in processcharacterization studies? process validation is defined as thecollection and evaluation ofdata, from the process design stagethrough commercial production,which establishes scientificevidence that a process is capable ofconsistently delivering qualityproduct.FDA process validation guidelineAuthorities stress the importance of datacollectionintheprocessvalidationguidelines. Essential activity in processcharacterization is the collection of (nonGMP) data to support the regulatory filing.This includes data from upstream (fermentation) primary recovery downstream quality small scale (laboratory) manufacturing scale commercial-like runs DoE experiments, one factor at a timeexperiments and many moreIn process characterization studies, datastructures and types are highly complex(time series data, one-point quality data,SDS page scans ). Data originates from abroad selection of sources (laboratoryequipment, LIMS systems, large scalemanufacturing process control systems,manufacturing execution systems). Datafrom laboratory (small scale experiments)and large-scale manufacturing needs to beintegrated for joint analysis.How to realize data management is akey question professionals involvedwith process characterizationstudies have to answer.Read more about data management andhow this supports analytics workflows in“best practices for fermentation dataanalytics”.EXPUTEC GmbH www.exputec.com 43-(0)1-997 28 49 contact@exputec.com 2017. All rights reserved.4
What is process characterization?How does Exputec support leadingAbout Exputecbiopharmaceutical companies in processExputec is a technology-driven consultingcharacterization studies?and software company delivering solutionsExputec consulting and statistical servicesfor the biotech and chemical processstreamlinescharacterizationindustry. Exputec uniquely combines datastudies and interactions with regulatoryscience and engineering competencies toauthorities such as FDA and EMA bysolve manufacturing challenges.bioprocessadopting statistical best practices.Accelerate the development of next levelbioprocesses, improve the speed uctoptimizeyourproductivity with the most advancedbioprocess data management and dataanalytics software inCyght . Define arobust scale up of your bioprocess andquality controls with the help of consultinginCyght surevisualization and data analytics softwaretechnologymanages the constant stream of process andcharacterizations, robust quality controlsquality data in one intuitive softwareandenvironment.campaigns. You will rapidly adopt lities in data management, dataanalysis and statistical reporting. You willFor more information please contact:EXPUTEC GmbHMariahilferstr. 147/2/2D1150 een chemistry manufacturing andcontrols- (CMC), quality control- andmanagement departments to act today forthe quality of tomorrow.www.exputec.comM: contact@exputec.comT: 43-(0)1-997 28 49EXPUTEC GmbH www.exputec.com 43-(0)1-997 28 49 contact@exputec.com 2017. All rights reserved.5
manufacturing process control systems, manufacturing execution systems). Data from laboratory (small scale experiments) and large-scale manufacturing needs to be integrated for joint analysis. How to realize data management is a key question professionals involved with process characterization studies have to answer.
