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Paul Adams, MSc,Senior BioprocessingTrainerSpecialises in the areasof upstream processing,viral clearance and disposable technology.Adam Pritchard, PhD,Senior BioprocessingTrainerSpecialises in the areas ofupstream processing, advancedtherapy medicinal products and disposabletechnologies.Aoife Barron, BSc,Senior BioprocessingTrainerSpecialises in the areas ofAseptic Processing, Fill Finishand QC Microbiology and leading the creationof an Industry 4.0 Innovation Centre at NIBRT.Maja Kristek, PhD,Senior BioprocessingTrainerSpecialises in the area ofbioanalytics and quality control.Tadeusz Tazbierski, MSc,Bioprocessing TrainerSpecialises in the areas ofupstream processing anddisposable processing.Patrick Torrie, BSc,Bioprocessing TrainerSpecialises in the areas of processautomation, upstream anddownstream processing.Carl Bermingham, MSc,Bioprocessing TrainerSpecialises in the areas ofUpstream Processing andDisposable Technology.Eoin Gunnigle, PhD,Bioprocessing TrainerSpecialises in the areas of QCMicrobiology and Bioanalytics.Aoife Kearney, PhD,Bioprocessing TrainerSpecialises in the areas ofdownstream processing andprotein purification.Robert Byrne, BSc,Bioprocessing TrainerSpecialises in the areas ofdownstream processing anddisposable technologies.Dermot O’Sullivan, PhD,Bioprocessing TrainerSpecialises in the areas ofUpstream Processing & Fill Finish.Úna McVeigh PhD,Bioprocessing TrainerSpecialises in the areas ofdownstream processing andbioanalytical testing.Gillian Casey, PhD,BioprocessingTrainerSpecialises in the area ofbioanalytical testing.Alex Ostropolska, MSc,Online Training SpecialistSpecialises in the area of onlinetraining for the NIBRT OnlineAcademy.Stephen McCann, MScSpecialises in Bioprocessingtechnology.NIBRT Training Catalogue 20209

5Customised CoursesNIBRT specialises in designing, developing and delivering customised training programmesto meet the requirements of industrial clients. All aspects of the course can be customisedin discussion with the client including:Customised Content We will develop and implement course content to your specifications in order to replicate howoperations, processes and procedures are applied in your organisation.Customised Scheduling We can organise training courses to suit your business priorities and work schedules.Customised Delivery NIBRT can deliver courses to clients via online learning or by on-site visits if required.Customised training solutions delivered for the clients above in 201910NIBRT Training Catalogue 2020

6Case StudyTakeda Dunboyne BiologicsTakeda have invested over 600M in a new stateof-the art biologics facility in Dunboyne, Co. Meath,Ireland. This single-use and paperless facility willprovide significant flexibility to meet the growingdemands of biologic products and will be fullyoperational in 2020. Takeda Dunboyne Biologicswill be at the cutting edge of innovation in thebiopharmaceutical industry with a biologics productportfolio that delivers the most innovative product forour patients.Takeda’s vision is to create a highly committed, agileteam of champions, delivering life-changing medicinesto our patients where our learning environmentprovides individuals the opportunity to reach theirfull potential, where customer value is constantlychanging and our thinking is at the edge of next.To achieve this vision, Takeda developed an innovativecollaboration with NIBRT: To design, develop and deliver customized trainingprogrammes to enhance the biomanufacturingskills of the Takeda teams by leveraging the NIBRTGE Single Use Technology Centre of Excellence,and Emerson manufacturing automation suite. To setup a laboratory in NIBRT with Takedaqualified equipment to implement the QualityControl (QC) Teams training in NIBRT and onreturn to Dunboyne to successfully fast-track thetechnology transfer process. To train the agile teams in the NIBRT facilityincluding Manufacturing, Engineering, Facilities,Micro and Support Teams. To base 20 QC employees at the NIBRT facility fornearly 12 months to support our start-up activitiesin Dunboyne. To host Takeda Careers in Biopharma eventsat NIBRT to help hire the best scientific andengineering talent.“Well done team Dunboyne on great partnershipwith NIBRT - great example of win:win partnershipall round. How great to see how good honestpartnerships flourish when based on solid values andshared values - well done all concerned and thanksfor keeping our learning organization principles front& centre in this journey”Ann Lyons, Head of Learning, GMS at Takeda“Thank you to the great team at NIBRT forsupporting the start-up at Dunboyne. We lookforward to continuing to build on this importantpartnership to deliver our workplace of the future.”Susan Hynes, VP and Site Lead TakedaDunboyne BiologicsThe Takeda Dunboyne Biologics team at NIBRTWinner of the 2019Invest in Ireland StaffUpskilling AwardNIBRT Training Catalogue 202011

7NIBRT OnlineAcademy (NOA)NEW FOR2020The NIBRT Online Academy (NOA) provides industry leading, elearning courses on keyaspects of biopharma manufacturing.NOA courses can be accessed online (https://noa.nibrt.ie) on a range of devices to provide “just intime” learning in an engaging, stimulating format. NOA courses can also be installed on Client’s LearningManagement Systems, with individual and group pricing options also available.NOA elearning courses: release datesOctober 2019January 2020April 2020Biotechnology andBiopharmaceuticalsCell Biology and RecombinantDNA TechnologyBioreactors in BioprocessingOverview of BiopharmaceuticalManufacturingFermentation inBiopharmaceutical ManufacturingDownstream Processing:CentrifugationCell Culture in BiopharmaceuticalManufacturingDownstream Processing:Ultrafiltration and DiafiltrationAseptic Processing - GowningDownstream Processing: ProteinPurification - ChromatographyFreeze DryingAseptic Processing –Decontamination and SterilizationTechnologiesFormulation in theBiopharmaceutical IndustryAseptic Processing –Contamination ControlClean In PlaceAseptic Processing – Conceptsand ControlsProcess Validation: ProcessQualification and ControlAseptic Processing - Cleanroomsand Control TechnologiesProcess Validation:Process Design12NIBRT Training Catalogue 2020

8Short CoursesNIBRT’s highly popular portfolio of short, intensive courses provides:Access to state-of-the-art NIBRT facility and equipmentFocus on the equipment and solutions to the real challenges you face in your own workplaceOpportunities to share experiences with people from a variety of organisationsUndisturbed time for training away from workplace interruptionsThe current schedule for short courses in 20202 is shown below:CourseNEW FORIntroduction to Single Use Technologies in the2020 Biopharmaceutical IndustryIntroduction to Bioprocessing for Non-Scientists2020 datesMay 05 06 1,500September 03 04April 30 May 01September 01 02 600 perdayDecember 01 02Introduction to Downstream Processing OperationsFebruary 05 06 1,500May 20 21July 15 16September 16 17December 9 10Introduction to Fill Finish OperationsFebruary 17 – 19 2,250May 25 – 27July 20 – 22September 21 – 23December 14 – 16Introduction to QC MicroMay 06 750September 01Introduction to Upstream Processing OperationsFebruary 03 04 1,500May 18 19July 13 14September 14 15December 7 8Navigating QC Testing for Biologics and BiosimilarsMay 06 – 08 2,250October 06 – 08QC Micro Skills for BiopharmaJune 09 – 11 2,250September 29 – October 012 All price and course details are correct at time of publication but are subject to change, please refer to https//:www.nibrt.ie for themost current information or contact training@nibrt.ieNIBRT Training Catalogue 202013

NIBRT Partner Short CoursesCourseNEW FOR2020 datesBPS CrowthorneLyophilisation technology: Products, Process and SystemsMarch 11 – 13 2445(EarlyBirddiscountsavailable)CCMI and NIBRTFundamentals of Stem Cell Therapy ManufactureMay 11 – 15 3500CfPIEMarch 11 – 13 2650(EarlyBirddiscountsavailable)CfPIEWriting Effective SOP and Other Process DocumentsMarch 09 – 10 2150(EarlyBirddiscountsavailable)Engineers IrelandJanuary 23 450 EIMembers2020 Technical Writing for the Pharmaceutical, Medical DeviceSeptember 21 – 25and Biotech IndustriesNEW FOR2020 February 20March 26April 22May 21 550NonMembersJune 25July 23August 27September 24October 22November 26December 17NEW FORGE Fast Trak2020 Advanced cell therapy technologyJanuary 28 – 30 2,960June 09 – 11October 06 – 08NEW FORHuman Factors in Life Sciences. Connect Academy Human2020 Factors in Life SciencesMarch 31 900July 02Inspired PharmaPharmaceutical GMP Auditor /Lead AuditorJune 22 – 26 3295Kaye AmphenolIntroduction to Thermal ValidationMarch 12 500NSFGMP for Biological and Biotechnology ProductsJuly 14 – 17 2,900STERIS Life SciencesCleaning Validation MasterclassJune 24 – 25 1,55014NIBRT Training Catalogue 2020October 15October 28 – 29

QC Micro Skills for BiopharmaCourse DescriptorThis comprehensive 3-day course is designed to equip QC Microbiologyanalysts with the main theory and practical experience required to developtheir skills in a GMP biopharmaceutical microbiology laboratory. The coursewill cover microbiology basics as an introduction to the remaining classroombased lectures and lab-based practical sessions, including Growth PromotionTesting and BIs, Environmental Monitoring and Water Testing, MicrobialIdentifications, and Adventitious Agents testing. The course will also covera regulatory overview of micro lab requirements as well as how to approachcommon lab deviations.Who should attendQC Micro personnel looking for a refresher or introduction to the relevanttheory and practical elements of common microbiology lab tests.Lab management personnel who want to refresh their knowledge on testingprotocols and regulatory requirements.QA, Manufacturing or Engineering personnel who have an invested interestedin what happens in a QC Micro lab.NEW FOR2020 Introduction to Bioprocessing for Non-ScientistsCourse DescriptorThis course is designed to give attendees an overview of the main processesinvolved in biopharmaceutical manufacturing.Day 1 of the course covers theory introducing the biopharmaceutical industryand the main processes including upstream, downstream and fill finishoperations. The course includes interactive tours of the NIBRT training facilitycovering the pilot plant processing suites, single use and utilities areas.Day 2 of the courses is an optional add-on day focussing on hands onpractical sessions in upstream, downstream and fill finish processingactivities.Who should attendThis course is designed to give anyone working in or looking to move intoareas associated with the Bioprocessing industry a good overview of theoperations involved. E.g. Recruitment personelle, business and finance teams,suppliers & vendors sales teams etc.Introduction to Downstream Processing OperationsCourse DescriptorThis course is designed to deliver an introduction to the typical downstreamoperations used in a biopharmaceutical production process. This courseincludes both hands-on practical and lecture components covering topicssuch as ultrafiltration/diafiltration, viral clearance and chromatography.During this course trainees will be introduced to the basics of UF/DF andchromatography in a theory session before building on this knowledge andperforming these operations using a practical component.Who should attendSuitable for: operators, technicians, engineers & managers This courseis designed for those that are new to downstream processing includingoperators, technical staff, engineers and managers who need to increase theirbasic knowledge of actual operations in a modern downstream processingbiopharma plant.NIBRT Training Catalogue 202015

Introduction to Fill Finish OperationsCourse DescriptorThis three day programme is designed to provide an introduction to currentaseptic techniques related to working in an aseptic filling environment.This blended programme provides both a theoretical introduction tocontamination control, environmental monitoring, filter integrity testing andfilling systems, while also allowing trainees hands-on interaction with bothisolator and RABs units while conducting glove integrity tests, media fills andtroubleshooting. An introduction to Grade B gowning will also be included inthe programme.Who should attendManufacturing QA/QC Engineering Technicians Specialists Operators.Introduction to QC MicroCourse DescriptorThis one-day course is designed to provide the trainee with an introductionto microbiology and its practical application in a GMP biopharmaceuticalmanufacturing environment. Classroom-based lectures and hands-onpractical sessions will introduce the aseptic practices of environmentalmonitoring and water sampling as well as the use of common microbiologylab equipment such as BSCs, microscopes and gram staining equipment.Who should attendNew recruits to QC who are looking to familiarise themselves with the theoryand practical elements of standard micro testing. Lab management personnelwho want to refresh their knowledge on testing protocols and requirements.QA, Manufacturing or Engineering personnel who have an interest in whathappens in the laboratories.Introduction to Single Use Technologies in the Biopharmaceutical IndustryCourse DescriptorSingle Use Technology is widely used within the biopharmaceutical industryand has quickly become a mainstay within the sector.This training programme will highlight the readily available technologies thatcan be implemented in upstream and downstream processing. It will allowtrainees to gain hands on experience of common disposable technologiesused in upstream and downstream processing including bioreactors,chromatography systems, UFDF systems, connects/disconnects and tubewelders and sealers.Who should attend16This course is designed for those that are new to the use of single usetechnologies, including development scientists, process engineers, andmanufacturing operators. It is expected that attendees will have a basicknowledge of the manufacturing process prior to attending the course.NIBRT Training Catalogue 2020

Introduction to Upstream Processing OperationsCourse DescriptorThis two day course provides an introduction to the typical upstreamoperations carried out in a biopharmaceutical manufacturing facility. Thiscourse will include both hands-on practical and theory components. Duringthis course trainees will be introduced to cell culturing techniques using smallscale shake flasks. Trainees will then gain hands on practical experience usingboth stainless steel and disposable bioreactor systems. Trainees will prepareand run a steam in place cycle on a stainless-steel bioreactor and theninoculate a production batch into a stainless steel bioreactor.Who should attendThis course is designed for operators, technical staff, engineers and managerswishing to increase their knowledge of the upstream operations in a modernbioprocessing plant.Navigating QC Testing for Biologics and BiosimilarsCourse DescriptorThis three-day course guides trainees through the Critical Quality Attributesof biologics (ICH Q6B) as well as core analytical platforms routinelyemployed in a QC testing environment in order to measure them. Usinga combination of lecture sessions and hands-on practical training, thecourse will cover methods such as electrophoretic separations (capillaryelectrophoresis, slab gels), HPLC/UPLC methods (peptide mapping, SEC,etc), nanoDSF (label-free nanoscale Differential Scanning Fluorimetry) andimmunoassays (ELISA).Who should attendThis course is suitable for graduates seeking to gain entry into the areaof biopharma QC, those currently working in QC/QA (small molecule orlarge), those working in product or process development/characterisation oranyone looking to increase and expand their understanding of QC testing forbiologics and biosimilars.NIBRT Training Catalogue 202017

NIBRT Partner Short CoursesBPS CrowthorneLyophilisation technology: Products, Process and SystemsCourse DescriptorThis course provides a comprehensive insight into a wide range of elementsin freeze drying, including details on the concepts and practical aspects ofeach step of the process, principles and methodologies for formulationdevelopment and characterization. Additionally, it covers approaches tocycle development and scale-up including Quality by Design, fundamentalequipment features of refrigeration, vacuum and control systems i.e. PATtools, and aspects of troubleshooting, maintenance and qualification.Who should attendSuitable for people working in biotechnology, pharmaceutics, freeze dryingformulation and cycle development, diagnostic industries.CCMI and NIBRTFundamentals of Stem Cell Therapy ManufactureCourse DescriptorStem Cell Therapy is an area of increasing investigation and investment as atreatment option for patients with a previously unmet clinical need.This training programme, presented as a collaboration between the Centrefor Cell Manufacturing Ireland (CCMI) and NIBRT, will cover all aspectsof stem cell therapy manufacture. It will allow trainees to gain hands onexperience of cell vial thaw, initial seeding, expansion and cryopreservationas well as the associated equipment required to carry out these tasks. Inaddition, trainees will gain insight into the morphology of stem cells andindications of cell culture contamination, allowing them to identify andtroubleshoot potential issues.Who should attendThis course is designed for those that have some knowledge of cell culturetechniques but would like to specifically learn how stem cell therapymanufacture is conducted. This course would be ideally suited to graduateswith a cell culture background or cell culture technicians from a biologicsmanufacturing setting.NEW FOR2020 CfPIETechnical Writing for the Pharmaceutical, Medical Device and Biotech IndustriesCourse DescriptorThis medical writing course’s notes and interactive exercises address howto write effective correspondence and reports in support of the company’sactivities. You will learn how to organize and deliver information for theintended audience, as well as how to write clear and readable documents, andhow to revise and refine your own and others’ writing. The course provides anoverview of sound grammatical conventions, addresses problematic areas ofthe English language, and affords opportunities to address specific languageissues.Who should attendScientists, engineers, and technicians in research and development willfind this medical writing course valuable, as will quality assurance (QA),information technology (IT), manufacturing, and other operationsprofessionals. This technical writing training course is also useful foradministrative staff that must prepare documentation in support of R&D andoperations activities. Additionally, the course is helpful for anyone who wantsan in-depth and comprehensive overview of the structure of the language andwriting within the broad range of reporting that the industry requires.18NIBRT Training Catalogue 2020

NEW FOR2020 CfPIEWriting Effective SOP and Other Process DocumentsNEW FOR2020Course DescriptorThis course presents a comprehensive overview of process writing that thebinding regulations require. This course presents process writing withinthe “big picture” of controlled documentation and gives industry standardsfor delivering information. Particip

NIBRT Training Team 8 5. Customised Courses 10 6. Case Study: Takeda Dunboyne Biologics 11 7. NIBRT Online Academy (NOA) 12 8. Short Courses 13 9. MSc Programmes 23 10. . Delta V training with Emerson, MSc. Immunotherapeutics, CPD Diploma in Professional Engineering & Biopharmaceutical Operations, UT Sydney joining .