About This Course
Fact File
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Title
(Bio) Pharma Processing
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Code
PDBPP
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College
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Duration
12 months
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Teaching Mode
Part-Time
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Qualifications
PG Dip
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NFQ Level
Level 9
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NFQ Award Title
Major
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Fees
€6,000 See Fees and Costs for full details.
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Entry Requirements
A candidate must have obtained at least a Second Class Honours primary degree in a relevant Pharmacy, Science or Engineering discipline (NFQ level 8). In exceptional cases applicants not meeting the above criteria will be considered for entry based on an interview and successfully demonstrating that they hold an equivalent professional qualification, or significant industrial experience relevant to the course. See Requirements for full details.
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Closing Date
27th August 2021
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Next Intake
September 2021
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Venue
UCC
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Start Date
September 2021
Course Outline
The Postgraduate Diploma in (Bio) Pharma Processing is designed to facilitate science or engineering graduates who hold sufficient educational or professional experience to transition into the BioPharma and PharmaChem sector nationally. Development and delivery of this level 9 course in the Munster area, where comparatively high numbers of BioPharma and PharmaChem companies are situated, will provide participants with experience in the manufacture of active pharmaceutical ingredients (both small organic molecule and biopharmaceuticals) and their formulations. The programme has a key focus on upstream/ downstream processing; sterile working environment; practical training; industrial standards and regulation; collection and analysis of data; validation; novel and personalized therapies; formulation and delivery of biological drugs. This combination of modules, which spans both the drug development and drug manufacturing processes, and has been designed to meet the existing and projected needs of the industry, will help produce confident graduates that are technically competent for employment in the BioPharma and PharmaChem sectors. It will improve the skillsets of those already employed in the industry, and provide a much needed increase in the talent pool available for employment.
MODULES
Students will complete 60 credits as follows:
PF6603 Introduction to the Principles of Formulation and Dosage Form Design (5 credits)
PF6605 Microbiology and Sterile (Bio) Pharmaceutical Processes (5 credits)
PF6607 Pharmaceutical Process Design and Verification (5 credits)
PF6609 GxP - Regulatory and Best Practice Standards in the (Bio) Pharmaceutical Industry (5 credits)
PF6610 BioPharmaceutical Technology and Processes (10 credits) PF6612 Research Methods in (Bio) Pharma Processes and in the Development of Novel BioTherapeutics (10 credits)
PF6611 Biologics: Formulation and Dosage Form Design (5 credits)
PF6612 Research Methods in (Bio) Pharma Processes and in the Development of Novel BioTherapeutics (10 credits)
PF6613 Introductory Statistics for the (Bio) Pharma Industry (5 credits)
PF6614 Advanced (Bio) Pharma Technology and Data Analysis (10 credits)
Optional Module: PF6615 Transitioning into the Workplace and Placement (5 credits)
This optional module will be offered to students (subject to approval of the programme director) looking to transition into the workplace (i.e. those classified as jobseekers or returners). PF6615 is assessed on a pass/fail basis and is not counted toward the final award. The result obtained in PF6615 will be recorded on the student’s transcript.
Course Practicalities
Lectures/workshops will be scheduled on Fridays (09:30-17.30pm) from mid-September to the end of July. The programme will be assessed through a variety of formal written examinations, and continuous assessment (written assignments, practical reports, MCQs).
Why Choose This Course
This NFQ level 9 part-time course has been developed with input from world-leading companies based in Munster, and has been designed to meet the expected shortage of appropriately skilled employees in the sector in the coming years. It combines flexible on-campus and blended on-line teaching methods to deliver workshops, lectures and practicals to students from a range of disciplines and circumstantial backgrounds. The course features significant engagement with local industry through the provision of site visits, off-campus training opportunities and guest speaker lectures. Students will have the opportunity to avail of Career Services at UCC and take a non-credit bearing module that aims to assist them in transitioning to the workplace and facilitating a placement in a local company.
Placement or Study Abroad Information
Suitable students will be provided with an optional 5 credit module PF6615 focused on transitioning to the workplace which, where possible, will include a placement in a local company.
Skills and Careers Information
Graduates will develop knowledge and critical skills relating to GMP, aseptic and sterile manufacturing, upstream/downstream processing, cell culture, bioreactors, chromatography, filtration, viral clearance, media and buffer preparation, formulation, validation, bioanalytics, facility management, clean utilities, calibration, automation, equipment maintenance, environmental health and safety, continuous improvement, documentation management, quality person duties, batch release, regulatory filings, new product improvement and modifications. Graduates will be in a position to apply for a variety of positions including, but not limited to, Process Technician, Production Supervisor, Quality Assurance Specialist, Technical Services Scientist, Validation Science, Scientist (BioPharma), BioProcess Engineer and Process Scientist (Manufacturing Support).
Requirements
A candidate must have obtained at least a Second Class Honours primary degree in a relevant Pharmacy, Science or Engineering discipline (NFQ level 8). Consideration will be given to other applicants with sufficient equivalent professional qualifications and significant industrial experience.
Fees and Costs
€6,000 for full programme
€700 per standalone 5 credit module
Funding may be available via the Springboard+ scheme for this programme. Please see https://springboardcourses.ie/ to check your eligibility.
For further information on fees and financial supports please click here.
How Do I Apply
During your online application you will be required to upload the following documents:
- Application Statement
- Birth Cert or Passport
- Passport Photograph
- Curriculum Vitae
- English Language Test Report [if applicable]
- Transcripts [if applicable]
NOTE: Once you have selected your course your application saves automatically. If you don't complete your application in one session you can access your draft application in the "My Applications" section of the UCC360 application portal. The My Applications section will also keep you updated on the status of your application.
Apply Now
Year 1 Modules
- PF6603: Introduction to the Principles of Formulation and Dosage Form Design (5 credits)
Scientific principles of dosage form design. Physicochemical properties of drugs. Overview of routes of drug administration. Introduction to the formulation and manufacture of conventional dosage forms. - PF6605: Microbiology and Sterile (Bio) Pharmaceutical Processes (5 credits)
Pharmaceutical microbiology: overview, practical aspects and applications in sterile (bio) pharmaceutical products.Microbiological culture media: types, manufacture and quality control. Bioburden determination. Environmental monitoring. Identification of sources and routes of contamination. Sterile processing and control. Sterilization and sterility assurance. Cleaning and disinfection. Water for (bio) pharmaceutical preparations. Aseptic processing. Cleanroom design and control. Barrier isolation technology. Sterile dosage form design and manufacture. QC testing for sterile products: sterility testing, particulate testing, pyrogen/endotoxin testing. Preservation of (bio) pharmaceutical products and antimicrobial efficacy testing. - PF6607: Pharmaceutical Process Design and Verification (5 credits)
Risk assessment and quality by design. Equipment requirements and finishes. Scope and types of validation strategies, DQ, IQ, OQ, PQ concepts, Commissioning, Process verification, Cleaning validation, Analytical validation, Process automation and validation of process control systems (GAMP). Continuous process verification. - PF6609: GxP - Regulatory and Best Practice Standards in the (Bio) Pharmaceutical Industry (5 credits)
Introduction to regulatory affairs and (bio) pharmaceutical quality systems. Registration and licensing requirements for new medicinal products and facilities. An overview of cGMP requirements in the regulations. Selected topics on quality systems. Role and legal responsibilities of the Qualified Person. Pharmacovigilance and post marketing surveillance. Principles underpinning GCP, GLP, GDocP, GDP, GSP and GRP. Regulatory considerations for designing and conducting clinical trials. Medical device regulations. Regulatory approval pathway for biosimilars and advanced therapy medicinal products. - PF6610: BioPharmaceutical Technology and Processes (10 credits)
Introduction to pharmaceutical biotechnology. Principle and design of biological drugs. Vaccines. Recombinant therapeutic proteins. Introduction to antibodies and their derivatives (Including humanized monoclonals). Upstream and downstream processes in the manufacture of biopharmaceutical products. Choice and management of production cell line. Bioreactor design principles and practice. Expression, purification, characterization and analysis of protein drugs. Overview of fundamental unit operations (heat transfer, mass transfer, fluid dynamics). Downstream Processing (Filtration and Chromotography), Formulation Processes (Freezing/Thawing, Compounding, Pumping, Filling, Lyophilisation) and Packaging. - PF6611: Biologics: Formulation and Dosage Form Design (5 credits)
Physicochemical properties of protein-based therapies. Challenges to protein delivery. Protein-engineering and formulation approaches to overcome delivery challenges. Biotech products: handling, packaging, transport, storage. - PF6612: Research Methods in BioPharma Processes and in the Development of Novel BioTherapeutics (10 credits)
An introduction to the scientific logic that underpins research and optimisation studies. Refining research questions, research planning, searching for evidence (key words and electronic databases), collecting and presenting research data. Writing a literature review. Critically evaluating research quality, and its application to BioProcess and Novel Drug design. Review the recent advances in the field through the critical appraisal of study design in the areas of pharmacogenetics, 'Omic' technologies, personalised approaches to vaccination/advanced antibody derivatives/cell based therapies and gene therapy (including CRISPR gene editing, cloning, transgenics and BioPharming). Ethical implications of genomics and personal biological information. - PF6613: Introductory Statistics for the BioPharma Industry (5 credits)
Basic concepts and definitions. Presenting and summarising data. Measurement of central tendency and variation of data. Presentation of data. Probability and probability distributions. Statistical hypothesis testing. Sampling techniques and determination of sample size. Linear regression and correlation. - PF6614: Advanced (Bio)Pharma Technology and Data Analysis (10 credits)
Process analytical Technology. Continuous Processing. Real-Time Release. Chemometrics. Quality by Design. Quality by Control. Assuring quality of personalised medicines and advanced therapies. Introduction to Mechanistic and Empirical models. Design of Experiments. Design Space. Process capability. Multi-variate Analysis (Principle component Analysis and Partial Least Squares). - PF6615: Transitioning into the Workplace and Placement (5 credits)
Job Readiness; Exploring self-awareness and setting realistic career objectives; Understanding your strengths, development needs, opportunities and threats; Developing a career-management strategy and identifying career goals; Creative job-hunting both online and offline; Written applications, CVs and interview preparation; Implementing career plans; Industry relevant, problem base case studies designed to provide realistic insight into the issues faced by Biopharma and Pharmachem organisations. Develop the skills necessary to integrate into a workforce e.g. communication, teamworking, problem-solving, adaptability, reliability and punctuality. Establish positive working relations with colleagues, showing sensitivity to the needs of others and practicing confidentiality.