About This Course
(Bio) Pharma Processing
NFQ Award Title
€3,000 See Fees and Costs for full details.
A candidate must have obtained at least a Second Class Honours primary degree in a relevant Pharmacy, Science or Engineering discipline (NFQ level 8). See Requirements for full details.
28th August 2020
The Postgraduate Certificate in (Bio)Pharma Processing is designed for graduates who wish to transition into employment in the (bio)Pharma sector. The part time course provides pharmacy, science or engineering graduates, as well as candidates who hold sufficient previous educational/professional experience, with a technical overview of current processing in Pharmaceutical and Biopharma sectors. The programme design provides participants with both a theoretical and practical understanding of the processes involved in drug substance and drug product manufacture. It is delivered part-time by a combination of online distance learning supported by classroom workshops, practicals and site visits. Practical and training sessions are delivered in the advanced laboratory-scale processing facilities in the School of Pharmacy, University College Cork and the Cork Education and Training Board facilities in Carrigaline. Career coaching and job readiness skills are provided via the ‘Transitioning into the Workplace and Placement’ module that is optionally available for recent graduates, those interested in career changes or re-engaging with recruitment processes.
A typical workload for each module is as follows; Students will be expected to attend classroom workshops (UCC), practicals and site visits (approx. 30 hrs), undertake self-directed study in advance of classroom/practical sessions (approx. 30 hrs), continuous assessment assignments and/or prepare for end of semester exam (40 hours). Students are only required to attend classes at the university 1 day per week during each 12 week semester (Sept- Dec and Jan – April). For the 2019/2020 programme the classroom/practical/site visits are scheduled for Fridays 9.30a.m - 5pm.
Students will complete 30 credits as follows:
PF6603 Introduction to the Principle 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)
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 as follows (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
Assessment methods vary across the programme modules. All modules are assessed using continuous assessment (eg. practicals reports, site visit reports, written assignments, and group projects), with the P6605 and PF6610 modules also containing formal end of semester examinations (1.5 hours). The optional PF6615 ‘Transitioning into the workplace and placement’ module is assessed on a Pass/Fail basis. PF6615 is not required for progression and is not counted toward the final Certificate award. The result obtained in PF6615 will be recorded on the student’s transcript.
Why Choose This Course
The part-time programme provides participants with technical expertise for career progression in both the Biopharma-Pharmaceutical manufacturing sectors.
Key programme aspects include:
- Hands-on practical experience of unit operations at lab scale facilities in the School of Pharmacy, University College Cork and the Cork Education and Training Board facilities in Carrigaline.
- Practical application of the theory relating to pharmaceutical processing both Biopharma, Pharmchem and Drug Product.
- Delivery online and in-classrooms allowing flexible contact hours; On-site teaching at UCC Fridays only semester 1 and 2.
- Career coaching and job readiness workshops.
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.
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.
All applicants whose first language is not English are expected to have a minimum IELTS score of 6.5, with no individual section lower than 6.5.
Fees and Costs
€3,000 for full programme
€700 per standalone 5 credit module
Students who are registered on this programme are eligible to apply for the Financial Aid Fund for Part Time Students. Eligibility criteria applies. For more information see https://www.ucc.ie/en/finaidpt
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.
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.