Overview
The Biopharmaceutical sector is one of the fastest growing sectors in the life sciences area, both nationally and internationally, and this training programme is particularly suited to individuals who are looking to enter into this type of manufacturing environment. This training programme is designed to deliver training on the overall process of biopharmaceutical production and the cleanroom operations involved, including upstream, downstream, formulation/fill finish operations, along with the typical engineering processes of biopharmaceutical production.
The training programme will involve theoretical sessions to offer participants an introduction to all aspects of biopharmaceutical processing, and the wide variety of roles and responsibilities required to maintain a successful biopharmaceutical facility. Participants will then build on this knowledge with interactive practical sessions in the NIBRT (National Institute for Bioprocessing Research and Training) facility, which has been purpose built to replicate a modern bioprocessing plant with state-of-the-art equipment.
Programme
The aim of this programme is to provide attendees with the knowledge and skills required to gain an understanding of the Biopharmaceutical industry. Topics including upstream processing, cleanroom operations, downstream processing and facility design are included in this programme to provide attendees with the requisite knowledge, skills and professional competencies required to be part of the biopharmaceutical industry.
This programme is particularly suited to individuals who are looking to enter the biopharmaceutical manufacturing sector. Biopharmaceutical processing is a rapidly growing sector within the life-sciences industry, with immense opportunities for graduates. Global manufacturing of biopharmaceuticals has increased significantly over the last decade. At the core of this module is the development of industrially relevant practical skills – attendees will gain hands-on experience in the fully functional bioprocessing pilot plant in NIBRT, consisting of extensive upstream, downstream, fill-finish and the associated bioanalytical facilities. These facilities are all operated in a realistic GMP simulated, operational manufacturing environment. This programme will provide attendees with a comprehensive understanding of the principal scientific and engineering challenges in the manufacture of biopharmaceutical products.
Cleanroom Operations
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Cleanroom Classification
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Contamination Control
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Disposable Technologies
Upstream Processing
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Cell culture
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Cell scale Up
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Bioreactor Operation
Downstream Processing
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Chromatography
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Filtration
Facility Design
Learning Outcomes
On completion of this programme participants will be able to:
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Compare traditional small molecule manufacture to large molecule manufacture.
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Outline the key operations in a typical biopharmaceutical production process.
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Distinguish the key steps and unit operations involved in the upstream process of biopharmaceutical production.
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Differentiate the key steps and unit operations involved in the downstream process of biopharmaceutical production
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Evaluate the need for aseptic processing in filling operations and the regulatory demands around it.
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Establish what a cleanroom is and compare the types of cleanroom classifications used in the biopharmaceutical industry.
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Compare and assess the major sources of contamination in a bio-manufacturing facility.
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Analyse the generation, use and maintenance of clean utilities in biopharmaceutical production.
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Review the Building Management systems in place in the biopharmaceutical sector.
Optional Assessment
The module is assessed based by both written exam and individual assignment. The assessment of this module is carried out by a judging panel consisting of NIBRT trainers. This is an optional assessment process which participants can choose to complete.
Written Exam
Upon completion of the six course dates, a written examination is given to participants, based on the course content covered in the six course days. This written exam is designed to demonstrate the participant’s knowledge of the fundamentals of bioprocessing.
Individual Assignment
This assignment requests the learner to submit a report based on the practical sessions covered throughout the six course days.
About NIBRT
NIBRT is a global centre of excellence for training and research in bioprocessing located in a world class facility. This Biopharma for Engineers training course is a one-day course designed to deliver a detailed introduction to the bioprocessing industry and the operations involved focussing on key areas of engineering. The course involves theoretical sessions to introduce the trainee to the key areas involved in the bioprocessing industry followed by a walk-down of the equipment involved. The course will then focus on the utilities involved in the biopharmaceutical production process.
NIBRT also houses a state of the art Endress+Hauser instrumentation rig which will be a key focus of this training day for engineers. This equipment will be used to deliver an understanding of the theory of process measurement, control and digital communications and its application in an industrial process control environment.