B2144 - Applied Organic Chemistry: From Laboratory to the Market

Learning outcomes

The relationship between Academia and Industry is more and more important. The objective of this course is to equip students with the fundamental knowledge and practical tools needed to evaluate, design, and optimize synthetic processes for active pharmaceutical ingredients (APIs), considering the constraints imposed by intellectual property, cost, quality, sustainability, and Green Chemistry principles. The course will focus on both process design and implementation. Students will gain an understanding of industrially relevant solvents, reagents, and technologies, together with the analytical methodologies required to support product registration and market authorization. Regulatory aspects related to process development, scale-up, manufacturing, and quality assurance will also be addressed.

Course contents

Modern chemists must possess multidisciplinary expertise that enables them to drive innovation from concept through implementation.

There will be three lessons  by three sicientists/Managers coming from CDMO and Big Pharma.  

1. Drug Discovery e Molecular Complexity. The challanges and complexity of drug development is directlu realte to the evolution of the drug design and teh  introduction of new modalities. 

2. Modern synthetic methodologies trends in the Pharma Industry. The discussion will be on the segment of small molecules and iterative processes like peptides. 

3. Intellectual Property. The basis of IP protection in the farmaceutical segmants will be discussed in relationship to the drug discovery and development process. 

4. Green Technologies, catalysis & flow chemistry. The application fo the Green Chemistry Principles as a guideline for a sustanable drug development through green metrix will be discussed. Process Mass Intensity, Process INtensification,, IdealityFactor are the mein green metrics considered.

5. Analytical Challanges of drug development will be discussed. In aprticular genotoxic impurities, elemental impurities, nitrosamines etc

6. Solid State. Most of the drugs are at solid state and its impact on the drug discovery and development will be discussed.

7. Case histories of several drugs development form bench to market. During the course e are going to discuss several drug development approaches and their evolution dring teh drug discovery and development process. 

Readings/Bibliography

“From Bench to Market. The Evolution of Chemical Synthesis from Discovery to Industrial Production.”; Oxford University Press: Oxford, 2000.

Specific publications will be given to the students.

Teaching methods

Frontal course with slides projected and discussed in class.

Assessment methods

Oral examination that will be directly fixed with the Professor. This flexibility for teh students is linked to the fcat that it's an examination at teh last year of the master degree.

Students with learning disorders and\or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students ) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives.

Teaching tools

Copies of the slides in pdf will be provided to the students. During the Lessons several pubblications and url of key web site will be available to the students.

It is useful to remind that students cannot share or publish the slides of the course in full or in part.

Office hours

See the website of Walter Cabri