National Institute for Bioprocessing Research and Training (NIBRT)

NIBRT Catalogue 2013 2012 Training Education Training and Education Catalogue National Institute for Bioprocessing Research and Training (NIBRT) www.nibrt.ie

Contents Welcome letter 1 Open courses... 3 2 Customised Training Programmes... 4 3 Certificates in Science... 5 4 Springboard... 6 5 Education Programmes... 7 6 Masters Programmes... 8 7 Training Facilities... 9 8 What Our Clients Say... 11 9 NIBRT Awards... 12 Note: All prices and course dates are correct at the time of publication but are subject to change, please refer to www.nibrt.ie for the most current information or contact us on training@nibrt.ie or + 353 1 215 8100. We look forward to working with you. 1

Dear Colleague, Welcome to NIBRT s Training and Education Catalogue for 2013. NIBRT is an award winning institute based in Dublin, Ireland that provides training and research solutions for the (bio)pharma industry in state-of-the-art facilities. The NIBRT Building Our training solutions can be customised to meet your requirements using the latest instructional design and distance learning techniques to provide accelerated learning solutions. NIBRT s programmes are designed in partnership with industry to deliver flexible, competency based learning solutions that deliver immediate cost-effective benefits in the work place. We offer trainees unrivalled access to a fully operational manufacturing plant, in a simulated GMP environment that ensures trainees gain experience with both the equipment and the regulations of a cgmp plant. This catalogue summarises the wide variety of training and education solutions which we provide and we look forward to the opportunity of working with you in 2013. Killian O Driscoll, NIBRT Director of Projects. 2

1 Open courses Open courses are short, intensive programmes which are focused on a particular topic. The current schedule for open courses for 2013 is shown below. Course 1 Price Date 2013 Quality by Design and Design Space 2 1,200 28-31 January Process measurement, control and digital 1,860 22-24 January communications Investigations Bootcamp 3 1,790 29-31 January Bioanalytics I: Introduction to protein 1,100 26-27 February characterisation Flow Cytometry 1,100 7-8 March Bioanalytics II: Advanced protein characterisation techniques 1,800 20-22 March Freeze Drying: Process and Product 4 960 22-23 April Glycan Analysis I: UPLC 2,100 22-24 April Glycan Analysis II: UPLC/MS 1,650 25-26 April Upstream Processing 1,240 30 April 1 May Downstream Processing 1,240 2 May 3 May Fill Finish and Aseptic Processing 2,250 7 May 9 May Chromatographic techniques for therapeutic protein characterisation 2,100 29-31 May Upstream Processing 1,240 22 23 October Downstream Processing 1,240 24 25 October Fill Finish and Aseptic Processing 2,250 29 31 October 1. Full courses details are available from: http://www.nibrt.ie/cat_training_schedule.jsp All prices and course dates are correct at the time of publication but are subject to change, please refer to www.nibrt.ie for the most current information or contact us on training@nibrt.ie. 2. In association with Umetrics 3. In association with PharmaServ 4. In association with BTL 3

2 Customised Training Programmes A trainee in the NIBRT Fill Finish Suite All NIBRT training can be customised to meet client requirements: Customised Content We will develop and implement course content to our client specifications in order to replicate how operations, processes and procedures are applied in their organisation Customised Scheduling We can organise training flows to suit client s business priorities and work schedules Customised Delivery NIBRT can deliver courses to clients via distance learning or by on-site visits if required. 4

Level 8 Level 7 Level 6 2013 Training and Education Catalogue 3 Certificates in Science Certificates in Science are accredited, training programmes that have been designed in association with our partners, Pfizer, Merck Sharp Dohme, Janssen Biologics and Eli Lilly and Co. These programmes focus on upskilling clients on the key competencies required in (bio)pharma manufacturing. They are intensive programmes which are delivered via a blend of distance learning and practical modules (in the NIBRT facility). Certificate in Science Level 1 Title Credits 2 Price 3 ( ) Biopharma processing 30 3,150 Bioanalytical techniques 10 1,525 Sterile operations 30 3,150 Biopharma processing 30 4,950 Bioanalytical techniques 10 2,500 Biopharma engineering 4 30 4,950 Biopharma Science 30 6,300 Note 1 National Framework Equivalent level equivalent, www.nfq.ie. Accredited by IT Sligo. 2 European Credit Transfer and Accumulation System (ECTS) grading system. 3 Prices are based on a minimum number of students. 4 Available from Sept 2013 5

4 Springboard The Springboard initiative in higher education provides an exciting pipeline of free training programmes for those who are currently seeking employment in Ireland. NIBRT is currently inviting applications for the following Certificate in Science programmes which are funded by the Springboard programme. To apply for these programmes please contact training@nibrt.ie. Cert in Science in Level 1 Partner Type 2 Pharmaceutical Technology 7 IT Tallaght Classroom and practical Sterile operations 6 IT Sligo Distance learning and practicals Biopharma processing 6 and 7 IT Sligo Distance learning and practicals Bioanalytical techniques 6 and 7 IT Sligo Distance learning and practicals Biopharma engineering 7 IT Sligo Distance learning and practicals Biopharma Science 8 IT Sligo Distance learning and practicals 1. National Framework Equivalent level, ww.nfq.ie 2. All practicals are delivered in NIBRT 6

5 Education Programmes A trainee in the NIBRT upstream processing pilot plant NIBRT s education programmes are designed for clients who wish to attain a third-level accreditation. Our education programmes are delivered by distance learning techniques supported by comprehensive tutoring. Higher Certificate in Science in GMP and Technology Summary: This Certificate specifically designed to provide trainees with the skills necessary to work in a highly complex scientific manufacturing environment. The course is aimed at people who may or may not have any previous qualifications. Duration: 2 years part-time Accreditation: Level 6 (120 credits) Price: 5,250 BSc (Ordinary) in Pharmaceutical Science Summary: The course is aimed at production, technical grade and supervisory / managerial staff and provides trainees with the skills necessary to work in a changing, highly regulated and technology driven manufacturing environment. Duration: 2 years part-time Accreditation: Level 7 (60 credits) Price: 7,200 BSc (Hons) in Biopharmaceutical Science Summary: This course is geared towards graduates who can assume positions of responsibility in the pharmaceutical industry. It is a broad based and multi-disciplinary course. Duration: 2 years part-time Accreditation: Level 8 (60 credits) Price: 9,000 7

6 Masters Programmes M.Eng.Sc. in Biopharmaceutical Engineering Summary: This is an advanced postgraduate degree programme offering a combination of lectures, tutorials, practicals and project work delivered by university and industry experts. Duration: The full-time programme is completed in one year and the part-time programme can be completed over 2 or 3 years. Price: 7,040 (EU students) M.Sc. in Bioprocess Engineering Summary: The M.Sc. is an interactive and dynamic programme that will develop your knowledge and appreciation of the conceptual and factual bases for bioprocess design and operation. It also develops your understanding of bioprocessing, particularly the structures, roles and experimental methods associated with biopharmaceuticals, their analysis, production methods and technology for monitoring and control of bioprocesses. Duration: The full-time programme is offered on a one year full time and up to 4 years parttime. Price: 6,272 (EU students) M.Sc. in Biopharmaceutical Science Summary: The post-graduate programme in biopharmaceutical science aims to provide students with a comprehensive grounding in critical aspects of biopharmaceutical processing and their support Services, with specific focus on the product lifecycle of biopharmaceutical products and their associated processes. Duration: A part-time programme delivered by distance learning which can be completed in a 2-3 year timeframe. Price: 12,000 (EU students) NIBRT s Academic Partners 8

7 Training Facilities Trainees in the pilot plant control room The NIBRT training facility is a purpose-built, multi-functional building which replicates the most modern industrial bioprocessing facility. The total building area is approximately 6,500 m² over two floors. At the heart of the NIBRT building is the bioprocessing pilot plant, consisting of extensive upstream, downstream, fill-finish and associated analytical facilities. These facilities are all operated in a realistic GMP simulated, operational manufacturing environment. Laboratory scale cell bank,inoculum suite and protein purification. Upstream Suite: 1 x 30 litre and 2 x 150 litre bioreactors, perfusion system, centrifuge, depth and micro-filtration skids. Downstream Suite: 2 x ultrafiltration/diafiltration skids, 2 x chromatography skids, column packing skid, viral inactivation vessels and a number of integrity test stations. Fill-finish suite: a vial filling machine under LAF and RABS with associated preparation room and aseptic gowning room. Manufacturing Support: Buffer preparation suite; media preparation suite; equipment preparation. Central clean utilities including purified water, clean steam and CIP skids. Utilities process control system. Suite of analytical laboratories for product and process characterization. Courses are designed to maximise trainees hands-on practical exposure to all equipment, with a trainee to instructor ratio of approximately 5:1. NIBRT provides clients with an unrivalled opportunity to develop their knowledge, skills and experience in a safe, simulated GMP and cost-effective manner. 9

Complete Process and Product Characterisation Facilities NIBRT have developed a unique, world-leading bioanalytical laboratory to provide training programmes on complete product and process characterisation for (bio)pharmaceuticals. These programmes are delivered in state-of-the-art bioanalytical laboratories by leading experts with comprehensive industrial experience. The training focuses on providing clients with the practical skills, experience and theoretical knowledge to confidently perform an array of both basic and cutting-edge bioanalytical techniques. The training laboratory is fully equipped with a comprehensive suite of bioanalytical equipment for full characterisation of biopharmaceuticals, in terms of amino acid sequence, concentration, size, charge, purity, integrity, structure, post-translational modifications (particularly glycan structures) and process-related modifications. The lab also features state-of-the-art mass spectrometry and chromatography equipment including: Two Waters Xevo G2 QToF mass spectrometers (for LC-MS/MS analysis). One Waters Acquity UPLC. Two Waters Acquity H-class Bio UPLCs with UV and fluorescence detectors and titanium flow cells. There are many current and new tools available that enable scientific, risk-managed pharmaceutical development, manufacture, and quality assurance. These tools, when used within a system can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge. FDA Guidance for Industry PAT A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance 10

8 What Our Clients Say NIBRT training clients Continuous education, personnel development and up skilling are a key enabler to success in today's competitive environment. Finding the time for professional development and further education is hard in today's workplace. However, the programs that NIBRT & IT Sligo offer are of excellent value and greatly facilitate the balance between on-going education and demands of the work place. From personal experience, the Sligo IT / NIBRT distant learning programs are flexible, value add and industry friendly. Merck Sharp Dohme (MSD), Fergal O'Donovan, Director, Technical Services As someone coming from the small molecule industry with a Chemical Engineering degree I found the Masters in Biopharmaceutical Science very beneficial for understanding the fundamentals of Biotech manufacturing, the science, the equipment, the quality environment within which one must operate. The choice of modules and the content of those modules gave me a broad understanding of the entire Biotech business. The distance learning approach was a first for me but I found it very flexible, user friendly and above all else efficient when balancing work commitments. Overall an excellent experience. Eli Lilly & Company, Martin Boyle, Downstream Ops, Team Leader Biotech "We worked with NIBRT on numerous occasions, from training colleagues for the start-up of a new biologics facility (Production, QA, QC, Technical Services and the Senior Leadership team) to the up-skilling of some of our existing employees. In these projects NIBRT always worked with us in close collaboration and partnership to ensure that our exacting needs were met and that we benefited fully from their tremendous expertise in the area of biopharmaceutical manufacturing." Pfizer, Training Lead 11

9 NIBRT Awards In 2012 NIBRT has won the following national and international awards, ISPE/Interphex Facility of the Year Awards: Special Recognition for Novel Collaboration: The Facility of the Year program is the pharmaceutical industry s premier awards program dedicated to celebrating innovation and accomplishments in facility design, construction, and operation. The Judging Panel cited that advancements in pharmaceutical manufacturing sometimes come through innovative collaborations like NIBRT that can ultimately lead to game changing outcomes. Further Information: http://www.facilityoftheyear.org/foyawinners2012#nibrt 2012 BioProcess International Awards Winner of Manufacturing Collaboration of the Decade Award BioProcess International (BPI) has announced NIBRT as the winner of the Manufacturing Collaboration of the Decade Award. Further information: http://awards.bioprocessintl.com/ Prof Pauline Rudd, NIBRT awarded Center of Innovation Award from Waters Corp. Waters Centers of Innovation Program recognizes analytical scientists facilitating breakthroughs in health and life science research, food safety, environmental protection, sports medicine and many other areas. These leading scientists, in partnership with Waters, are using liquid chromatography and mass spectrometry to unlock the mysteries of science and take research down new and exciting paths. Further Information: http://www.waters.com/waters/nav.htm?locale=en_us&cid=134671201 Outstanding Achievement Award for MSD Training Programme with NIBRT and IT Sligo Merck Sharp Dohme (MSD) s site in Brinny, Co. Cork was given an Outstanding Achievement Award for its innovative partnership programme with the National Institute for Bioprocessing Research and Training (NIBRT) and Institute of Technology, Sligo. Further Information: http://www.nibrt.ie/cat_news.jsp?i=151 Online Courses win Taoiseach s Public Service Excellence Award NIBRT and IT Sligo, one of the leading providers of online courses in the country, has received a prestigious Taoiseach s Public Service Excellence Award in recognition of its role in increasing access to higher education for part-time and distance learners through online delivery. Further information: http://www.nibrt.ie/cat_news.jsp?i=168&p=100&n=119&cat_p=0&cat=39 12

Book a Training Course NIBRT Reception To register for a training course please complete and return the attached form. If you would like to discuss your training requirements further, please contact us at the details below. We look forward to hearing from you. Kate Cotter NIBRT Training kate.cotter@nibrt.ie Bernadette Gallagher NIBRT Training bernadete.gallagher@nibrt.ie Killian O Driscoll NIBRT Director of Projects killian.odriscoll@nibrt.ie National Institute for Bioprocessing Research and Training (NIBRT) Foster Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland. Web: www.nibrt.ie Phone: +353 (0) 1 215 8100 Email: training@nibrt.ie 13

Training Registration Form Name: Job title: Company / Institution (if applicable) Email: Phone number: Address: Date of request: Course Details Course title: Date: Number of attendees: Additional Information Would you like NIBRT to contact you to discuss a customised course? Please provide any additional relevant information. Would you like additional information on NIBRT training, research or services? Note: 1. Full payment must be received prior to the commencement of the course. Invoice and payment information will be sent upon receipt of Training Registration Form. 2. Please send this form to:nibrt Training Director, Foster Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland. Email: training@nibrt.ie FAX + 353 1 215 8116 Phone: + 353 1217 8107 14

www.nibrt.ie 2012 Training and Education Catalogue National Institute for Bioprocessing Research and Training (NIBRT)