C9595 - PHARMA INDUSTRY

Learning outcomes

Students will understand the principles of safety and innovation critical to the chemical and pharmaceutical industries. They will explore the management of chemical reactivity hazards, the application of sustainable biocatalytic processes, and the integration of green chemistry and advanced technologies in pharmaceutical development. The student is expected to be able to: 1. Recognize and manage chemical reactivity hazards to ensure safety in pharmaceutical and chemical processes; 2. Apply biocatalysis principles and technologies to design sustainable and innovative processes for pharmaceutical production; 3. Understand and implement best practices in pharmaceutical development, including quality systems, green chemistry principles, and analytical technologies for efficient and innovative drug design.

Course contents

The CU is composed of three modules with the following contents:

Pharmaceutical and Fine Chemicals Industry: The target of the module is to give the possibility to study the best in class technologies available in drug research and development. Intellectual property impact in the pharmaceutical industry will be discussed as well as the change in the quality system determined by the International Regulations. Pharmaceutical Green Chemistry; Drug Substance development and pharmaceutical green chemistry; Drug product challenges and total quality; Analytical development and most recent ICH guidelines

Sustainable biocatalytic processes: Basic principles of biocatalysis: enzymatic structure, origin of activity and selectivity, kinetic models. Reaction efficiency and green chemistry metrics for biotransformations. Application of biocatalysis to sustainable industrial processes: industrial biocatalytic reactions of one and several stages. Examples of biocatalysis in industrial mass production. Cascading multi-enzymatic systems. Immobilization techniques of isolated enzymes and whole cells: advantages in the recovery of environmentally friendly products. Examples of biocatalytic processes supported in nanoscale devices and enzymatic biosensors

Chemical Reactivity Hazards: Recognize and manage reactive chemical hazards and show how uncontrolled chemical reactions in the industry or laboratory can lead to serious harm and introduces key concepts for avoiding unintended reactions.
At the end of the module the student is expected to be able to:
understand the situation that can cause uncontrolled reactions.
identify all chemical reactivity hazards.
understand the key concepts for avoiding unintended reactions

Readings/Bibliography

Lecturer notes and slides

- Walter Cabri & Romano di Fabio “From Bench to Market. The Evolution of Chemical Synthesis from Discovery to Industrial Production.”; Oxford University Press: Oxford, 2000.- Walter Cabri “Industrial Synthesis Design With Low Environmental Impact In The Pharma Industry” in New Methodologies and Techniques for a Sustainable Organic Chemistry; Mordini,A. Ed.; Springer-Verlag WB/Nato Publishing Unit.; pp119

J. A. Tao, R. Kazlauskas, “Biocatalysis For Green Chemistry And Chemical Process Development” John Wiley & Sons, Editor

Teaching methods

The course unit is divided into three modules taught independently at different times in the academic year, each module is organized in theoretical classes where main concepts are introduced, as well as tutorial classes with discussion of case-study examples.

Assessment methods

Each module learning is evaluated independently, exploiting: i) written tests; ii) oral presentations or interviews; iii) written assignments or combinations of them. The Course Unit grade will be the arithmetic mean of grades from the three modules. ChIRS grades scale goes from 1 to 100, pass grade is
40, and will be translated into ECTS and different University scales. Criteria: knowledge on a very limited number of topics covered in the course and analytical ability that emerges only with the help of the instructor, using generally correct language → 40-45;
Knowledge on a limited number of topics covered in the course and independent analytical ability only on purely executive
issues, using correct language → 45-60;
Knowledge on a large number of topics covered in the course, ability to make independent critical analysis choices, mastery
of specific terminology → 60-80;
Essentially comprehensive knowledge on the topics covered in the course, ability to make independent critical analysis and
connection choices, full mastery of specific terminology, and ability for argumentation and self-reflection → 80-100.

Teaching tools

Lectures slides and notes will be available on the course moodle https://emmcchir-learning.ualg.pt

Office hours

See the website of Alessandra Tolomelli

See the website of Walter Cabri

See the website of Nuria Lopez Vinent