BIO09065 2019 Formulation and Delivery of Biopharmaceuticals

General Details

Full Title
Formulation and Delivery of Biopharmaceuticals
Transcript Title
Formulation and Delivery of Bi
Code
BIO09065
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Eva Campion
Programme Membership
SG_SBPRO_M09 201900 Master of Science in Bioprocessing
Description

This module deals with advanced methods of biopharmaceutical formulation and finish for stable drug delivery. It aims to provide students with a critical overview of the challenges faced in the formulation and administration of biopharmaceuticals and the strategies being adopted to overcome these barriers. The latest advances for successful formulation and delivery of biologic drugs will be described. 

 

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Assess the various challenges faced in the design and formulation of a biopharmaceutical drug.

2.

Discuss and apply the fundamentals of pre-formulation and formulation for a biologic drug.

3.

Describe and evaluate modern formulation technologies for use with biologic drugs.

4.

Appraise and investigate the various delivery routes for a modern therapeutic protein.

5.

Discuss and evaluate the concept of drug targeting and controlled release systems.

Teaching and Learning Strategies

This module will be delivered full time and the primary mode of dissemination will be lecture delivery. A blended learning approach will be adopted where students will attend both online and  live theatre lectures. This format will be augmented by both independent and directed learning strategies. A learning platform (such as moodle) will be used as a repository of educational resources (e.g. journals, online resource information) and also as a means of assessment (e.g. quizzes, uploading of assignments etc.)

Module Assessment Strategies

This module will be assessed using 100% continuous assessment and course work.  As part of the course work for this module a project will be undertaken by the student which will involve the preparation of a critical review article on a relevant topic. To support this assessment the students will participate in collaborative learning groups. This will afford the students the opportunity to become competent in evidence based discussion and develop critical appraisal skills as well as contributing to open discussions with peers. The project may also include an oral examination with both presentation and viva elements. The remainder of the grade for this module will be achieved through two in-class closed book exams. Self assessment tests and other forms of formative assessment will be provided to students to check their own progress towards achieving the learning outcomes of the module and to motivate learning. This approach is expected to address student learning needs, promoting critical thinking and evaluation skills. 

Repeat Assessments

Reassessment of this module will consist of continuous assessment(s).

Module Dependencies

Prerequisites
none
Co-requisites
none
Incompatibles
none

Indicative Syllabus

Assess the various challenges faced in the design and formulation of a biopharmaceutical drug.

  • Protein structure
  • Post-translational modifications
  • Physical and chemical considerations in protein stability

Discuss and apply the fundamentals of pre-formulation and formulation for a biologic drug.

  • Physicochemical characterisation
  • Analytical methods and stability testing of biologics
  • Buffer considerations
  • Excipients
  • Novel formulation approaches for biologics
  • Case Studies

Describe and evaluate modern formulation technologies for use with biologic drugs.

  • Lyophilisation
  • Spray drying 
  • Fill-finish technologies
  • Innovative technologies 
  • Case Studies

Appraise and investigate the various delivery routes for a modern therapeutic protein.

  • Parentheral delivery
  • Oral delivery 
  • Transdermal and topical delivery
  • Pulmonay and other mucosal delivery
  • Novel delivery approaches

Discuss and evaluate the concept of drug targeting and controlled release systems.

  • Targeted drug delivery
  • Passive and active drug targeting 
  • Drug carriers
  • Controlled release systems
  • Advancements and challenges in drug targeting 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Critical Review Article Project Project Written Report 50 % End of Semester 4,5
2 In-class Test Continuous Assessment Closed Book Exam 25 % Week 6 1,2
3 In-class Test Continuous Assessment Closed Book Exam 25 % Week 12 3,4,5
4 Self Assessment Formative Closed Book Exam - % OnGoing 1,2,3,4,5

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Online Online Lecture 1 Weekly 1.00
Directed Learning Flat Classroom Workshop / tutorial 2 Weekly 2.00
Independent Learning Not Specified Independent Learning 5 Weekly 5.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Recommended Reading
2013-12-16 Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs Wiley-Blackwell
ISBN 111817979X ISBN-13 9781118179796

"Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition" addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Recommended Reading
2001-12-25 Pharmaceutics: The Science of Dosage Form Design, 2e Churchill Livingstone
ISBN 0443055173 ISBN-13 9780443055171

A comprehensive textbook covering the design of dosage forms and all aspects of drug delivery systems. 'Pharmaceutics' in its broadest sense is the 'art of the apothecary' or, in simple terms, pharmaceutical preparations. It remains a diverse subject in the pharmacy curriculum, encompassing design of drugs, their manufacture, and the elimination of micro-organisms from the products. This books encompasses all those areas and pays particular attention to the design of dosage forms and their manufacture.

Recommended Reading
2015-04-23 Therapeutic Peptides and Proteins CRC Press
ISBN 9781466566071 ISBN-13 1466566078

There are more than 500 biopharmaceuticals on the market, including more than 200 therapeutic proteins, making biologics the fastest growing sector in the biopharmaceutical market. These products include more than 40 monoclonal antibodies, for indications ranging from treatment or mitigation of various types of cancer to rheumatoid arthritis. The clinical application of these therapeutic peptides and proteins is limited by several problems, such as lack of physical and chemical stability or the lack of desirable attributes for adequate absorption or distribution. Thus, as these therapeutic peptides and proteins are made available, it will be essential to formulate these drugs into safe, stable, and efficacious delivery systems. The pharmaceutical scientist involved in this effort needs to call upon the knowledge of several disciplines, such as pharmaceutics, medicinal chemistry, biochemistry, microbiology, and chemical engineering and needs to keep abreast with the latest research in the published literature. Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Third Edition provides a comprehensive overview of the field for scientists in industry and academia and for students, while also providing practical information on the challenges facing the formulation and delivery aspects of these unique macromolecules. In particular, the book: Explains how recombinant DNA techniques now allow us to produce therapeutic proteins in a commercially viable form Discusses the physical and chemical pathways of peptide and protein degradation Includes a detailed discussion of protein formulation and lyophilization Overviews the pharmacokinetic aspects of therapeutic peptides and proteins and discusses controlled delivery systems for parenteral administration, including microsphere formulations Discusses research progress on oral, transdermal, mucosal, and topical delivery systems discusses transdermal and topical delivery

Recommended Reading
2009-10-23 Delivery Technologies for Biopharmaceuticals John Wiley & Sons
ISBN 9780470688403 ISBN-13 0470688408

Advances in biotechnology have provided scientists with anincreasing number of biopharmaceuticals such as novel peptide andprotein drugs as well as nucleic acid based drugs for gene therapy.However, successful delivery of these biopharmaceuticals is a majorchallenge because their molecular properties lead to poor physicaland chemical stability in the body and limited membranepermeability. Therefore researchers are developing a range of newdelivery technologies and materials to enable these new drugs to bedelivered intact to their target sites. Delivery Technologies forBiopharmaceuticals describes strategies to overcome themain barriers for successful delivery of therapeutic peptides,proteins, and nucleic acid-based drugs or vaccines related to thesite of administration and the target site. Many of the approachesdescribed are reported in formulations in current clinical trialsas well as in marketed products. Contents include: challenges in delivery of biopharmaceuticals novel formulation approaches for peptide and proteininjectables non-viral chemical vectors and viral technology for delivery ofnucleic acid based drugs immune response, adjuvants and delivery systems forvaccines several examples of delivery systems for differentbiopharmaceuticals a critical assessment of delivery technologies forbiopharmaceuticals Delivery Technologies for Biopharmaceuticals is anessential single-volume introduction to the technologies used byresearchers to ensure efficient delivery of this exciting new classof drugs. It will be of value to researchers and students workingin drug delivery, formulation, biopharmaceuticals, medicinalchemistry, and new materials development.

Module Resources

Non ISBN Literary Resources

See book list. 

Journal Resources

Relevant, up-to-date publications will be made available via the online learning platform. 

URL Resources

Up to date links will be made available via the online learning platform. 

Other Resources

Relevant, up-to-date resources will be made available via the online learning platform.