Biopharmaceutical Processing

Certificate

Sonraí an Chúrsa

Course Code	SG_SBIOP_E07
Céim	7
Fad ama	1 year
Creidmheasanna	30
Modh Seachadta	Online
Suímh campais	Sligo
Modh Seachadta	Páirtaimseartha

Iarratas a dhéanamh

Iarratas a dhéanamh

Forbhreathnú Cúrsa

This courses is Free or 90% Funded under the Springboard+ and Human Capital Initiative (HCI).

The Certificate in Science Biopharmaceutical Processing (Special Purpose Award – Level 7) has been developed in consultation with the Biopharmaceutical industry in Ireland to ensure the course offers the skills and experience that is required for this growing industry sector in Ireland. The course has been developed and is offered in conjunction with NIBRT (National Institute for Bioprocessing Research and Training) with all of the laboratory work taking place at their state-of-the-art training facility in Dublin.

Please note: This programme is jointly offered by ATU Sligo and NIBRT (National Institute for Bioprocessing Research and Training).

Sonraí an Chúrsa

Bliain 1

Seimeastar	Sonraí an Mhodúil	Creidmheasanna	Éigeantach / Roghnach
1	Cell Culture Processing Level 7. This module aims to provide students with a broad understanding of the theory of cell culture processing as it relates to the biosynthesis of modern biopharmaceutical products. It will include a combination of theory and practical laboratory work. Torthaí Foghlama 1. Outline the fundamentals of cell biology, cell culture processing and explain the process kinetics relating to cell growth. 2. Describe the various bioreactor designs available and their key features including relative advantages and disadvantages of different operating loops. 3. Describe the main operating cvontrol loops for a modern bioreactor and the critical control parameters associated with bioreactor performance. 4. Perform a range of laboratory and pilot plant practicals relating to cell culture processing. 5. Communicate scientific information and data in an appropriate format.	10	Mandatory
1	Facilites and Utilities This module aims to provide students with a good understanding of the main support service areas involving both facilities and utilities that underpin the modern biopharmaceutical manufacturing industry. Torthaí Foghlama 1. To provide an explanation of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility. 2. To appreciate the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification. 3. To address the operational requirementsfor the manufacturing facility within an overall design. 4. To explain key concepts incorporated into cleanroom design and classification. 5. Describe the key principles involved in cleaning and sterilisation including CIP and SIP systems. 6. To understand the key elements of treatment and purification plant used to prepare water fit for bioprocessing operations.	05	Mandatory
2	Protein Purification L7. This course aims to provide students with a broad understanding and practical appreciation of the main theoretical concepts and principles of protein purification (downstream processing). This will include both theory some relevant laboratory practicals. Torthaí Foghlama 1. Outline the main elements of a downstream process design for protein capture and purification. 2. Describe the general theory and main principles of chromatography technology for protein purification applications. 3. Describe the general theroy and main principles of filtration technology for protein purification applications. 4. Describe the various viral exclusion and elimination technologies for downstream processing. 5. Perform a range of laboratory and pilot plant practicals relating to protein purification. 6. Communicate scientific information and data in an appropriate format and manner.	10	Mandatory
2	Formulation and Fill-Finish This module aims to provide students with an understanding of the main considerations in the formulation and fill finish of a biopharmaceutical drug. Torthaí Foghlama 1. Describe the key principles of aseptic processing as they relate to drug fill-finish operations. 2. Compare and contrast routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal). 3. Describe the main filling and closure technologies and their control and operation. 4. Explain the principles and applications of freeze-drying technology. 5. Outline the typical quality control measures required for a fill-finish operation.	05	Mandatory

Uaireanta Staidéir Molta in aghaidh na seachtaine

Our online courses have about 3 hours of live lectures per week (but this can vary per programme). Live lectures normally take place between 6pm and 10pm, Monday to Thursday but this may vary depending on the availability of specific lecturers. The recommended study time for a 5 credit module is 5 to 6 hours each week. This includes lectures, independent learning and revision.

Scrúdú agus Measúnú

This programme is assessed via continuous assessment and final semester exams.

Riachtanas Tinrimh ar an gCampas

Students are required to attend NIBRT for two days practical training per semester for the Cell Culture and the Protein Purification modules.

Dul chun cinn

This self-contained minor award enables learners to exit with a Certificate or progress to complete a full level 7 degree in Biopharmaceutical Science.

Download a prospectus

Réamheolaire Fochéime Online, Flexible and Professional Development Prospectus

Riachtanais Iontrála

To qualify for entry onto this programme a standard applicant must hold a prior Level 6 qualification in a cognate area (typically Science or Engineering) or equivalent qualification. Applicants who may not have the aforementioned qualifications but who may have relevant industrial experience (typically 5 years duration in a GMP environment) may apply for consideration through the ATU Sligo RPL (Recognised Prior Learning) process.

Recognition of Prior Learning

Applicants with other qualifications and with relevant work experience may also be considered through ATU Sligos Recognised Prior Learning (RPL) process.

RPL is a process that may allow you to gain admission to a programme or to receive exemptions / credit from some parts of a programme based on demonstrated learning that you may have achieved through another programme of study or through your work and career. Further information is available through www.atu.ie/recognition-of-prior-learning which our dedicated RPL portal or by contacting our admissions team at admissions.sligo@atu.ie

English requirement

Applicants whose first language is not English should provide evidence of English language proficiency. For further information on English language requirements click here

Táillí

Total Fees EU: €4500

Tuilleadh eolais faoi tháillí

Gairmeacha

Graduates from the Certificate in Biopharmaceutical Processing are ideally positioned to contribute to the Biopharmaceutical, Biotechnology, Medical Diagnostics, Medical Device and Pharmaceutical sectors.

According to the NIBRT annual report 2021, “The global sales of biologics exceeded $300 billion in 2021 with 13 of the top 20 medicines being biologics. From an Irish perspective, the biopharma manufacturing sector enjoyed very strong growth. IDA Irelands annual results for 2021 showed the highest Foreign Direct Investment (FDI) employment level ever (275,384 employees) with the highest employment creation figures ever in a single year despite the continued impact of Covid-19. Underpinning these results was a strong series of announcements in the biopharma manufacturing sector. Access to a diverse talent pool with a broad range of multi-disciplinary skills will be a key determinant of future success. In 2021, the Financial Times working with Cytiva published the inaugural Global Biopharma Resilience Index . Based on data from a survey of 1,165 biopharma executives from 20 countries, access to talent was identified as the primary weakness in the resilience of the global biopharma industry.”

We have consulted extensively with biopharmaceutical employers located both regionally and nationally to determine the types of skills and training needs required for this sector and all have indicated that there are skills shortages emerging in certain areas and occupations. A highly skilled pool of graduates will be needed to fill these roles and this course addresses this area.