Understanding Chemistry to Make Chemicals
Throughout his career, APIS Chem’s CEO Claudio Giordano, has been invited by universities and industries to lecture on optimizing industrial production via the understanding of the underlying organic synthetic principles. He has taught as both Adjunct Professor and Lecturer in academic institutions including the Politecnico of Milan and the University of Milan.
As a natural consequence of the teaching experience accumulated during all these years, Giordano felt the need to share his approach and experience with colleagues in the field of process chemistry, leading to the development of a specific training program entitled Understanding Chemistry To Make Chemicals.
The training program is available in two different course formats: an open format, aimed at young graduates working in various chemical companies on the R&D of API production; and a bespoke format, which is both in-house and tailor-made to the specific company needs.
An instance of the open format focused on the rational approach to Process Development took place in September 2017 in Milan, with the participation of several chemical companies and R&D representatives.
The key outcome of both open and bespoke approach will be to teach participants to effectively couple the theory-oriented academic approach with the practical industrial approach in their everyday work.
In all stages of the training program participants will be encouraged to pursue the integration of synthesis, analysis, quality and regulatory aspects as critical elements in the development of an API process.
An instance of the open format focused on the rational approach to Process Development of Active Pharmaceutical Ingredients took place in September 2017 in Milan, aimed at chemical and pharmaceutical companies with a view to industrial process optimization.
This course consisted in a critical analysis of chemical concepts in industrial process optimization, with the aim of minimizing environmental impact and energy expenditure, while maximizing economic return.
The course was aimed at technicians with experience in the R&D of process chemistry in chemical and pharmaceutical companies.
Depending on the syllabus the open format course typically lasts two or four days, with the latter being preferable in terms of effectively conveying the mindset at the root of the training program.
The course is aimed chiefly at employees with experience in the field of process development in API production, in both generic and innovative drugs.
An in-depth understanding at the conceptual level will be the cornerstone of more functional development of chemical processes. In all stages of the training program participants will be encouraged to pursue the integration of synthesis, analysis, quality and regulatory aspects as critical elements in the development of an API process. Additionally, participants will be introduced into the key metrics for process scale up, chiefly in relation to ecology and economy.
The training approach will revolve around the discussion of case studies from the industrial field in order to expand upon the most critical and current aspects while not losing sight of the production goals.
The course instructor is Dr. Claudio Giordano, CEO of APIS Chem, backed up by other experts as lecturers on specific topics, as highlighted.
The course that took place in September 2017 in Milan, went through the following topics:
- Drug Substance and Drug Product
- Analysis and regulatory aspects
- Kinetics and Thermodynamics
- Phase Transfer Catalysis
- Process Scale-Up
- Stereochemistry and stereoselective synthesis
National and international speakers contributed to the understanding of selected aspects, such as:
- Green Chemistry – Metrics and Economic aspects
- Process Safety Evaluation
- Intellectual Property
- Importance of Solid State Chemistry in Process Development
We are offering a customized and enhanced version of the original training course in an in-house format for companies active in the R&D and production of APIs.
As a private training course this learning experience has proven to be effective: its tailor-made approach brings about a lasting transformation of mindset and work practice at a group level rather than merely at an individual one, with consequent immediate benefits for the organization.
The key outcome will be to teach participants to effectively couple the theory-oriented academic approach with the practical industrial approach in their everyday work. An in-depth understanding at the conceptual level will be the cornerstone of more functional development of chemical processes. In all stages participants will be encouraged to pursue the integration of synthesis, analysis, quality and regulatory aspects as critical elements in the development of an API process.
The course will open with an introduction to the key defining elements of drug substance and drug product (DS&DP) and their relationships. “To measure is to know”, and as a key emphasis participants will be introduced into the driving metrics for process scale up, chiefly in relation to ecology and economy, along with Barry Trost’s Atom Economy.1)
A working knowledge of the underlying kinetic2) and thermodynamic2) concepts will be pursued as the key to success for a competitive development of API synthetic processes.
Particular emphasis will be placed on the nature of solvents3), going onto explore their effects3) and role in catalysis4) in designing industrial organic processes5). As today many APIs are pure stereoisomers, stereochemistry6) and stereoselective synthesis6) will necessarily be touched upon.
Furthermore, the course acknowledges the increasing importance of the solid state7) at all levels, including that of the industrial process. Participants will thus be given the opportunity to become familiar with its practical applications.
In line with the contemporary needs of the chemical industry, the course will facilitate the understanding of how to minimize environmental impact and energy expenditure, while maximizing the economic return.
Last but certainly not least, intellectual property law will be explored, demonstrating its value more as an opportunity than a menace.
Why an on-site format?
- Aggregation, knowledge-sharing and teambuilding aimed at different specialist roles within the same or different areas of the company.
- On-site training with large-scale participation at lower costs.
- Customizable content.
Who should attend
MSc to PhD level Chemists currently working in the field of process chemistry, as well as experienced technicians from the following departments:
- Process chemistry (laboratory, kg-lab, pilot, production).
- Analytical chemistry (to familiarize more closely with process chemistry).
- Chemical engineering (to incorporate the understanding of advanced chemistry in the development of industrial processes).
- Other departments.
Depending on the syllabus the bespoke format course typically lasts two or four days, with the latter being preferable in terms of effectively conveying the mindset at the root of the training program.
The course instructor is Dr. Claudio Giordano, CEO of APIS Chem, backed up by other experts as lecturers on specific topics.
Provided upon request.
As an integration and completion to the title of this Course, it is fundamental to bear in mind Lord Kelvin’s statement: “To measure is to know”, as a premise to “Understanding chemistry to make chemicals”.
The following notes integrate the text and exemplify some of the highly innovative and uncommon course contents.
- Maximizing the number of atoms of all raw materials that end up in the product.
- Why does a chemical reaction happen? – Gibbs energy and its impact on process strategy. – Empirical chemical kinetic aspects: Reactants, Products, Intermediates, Activated complexes, Spectators, Catalysts, Inhibitors.
- Key importance of Hydrogen-bond. – The exchange mechanism of proton transport in water. – Acids and bases in non-aqueous medium. – The σ-bond basicity. – The fourth phase of water.
- Modern practical aspects of phase transfer catalysis. – Transition metal-based catalysis in industrial API processes. – Catalyst or pre-catalyst. – Influence of metal purity of Transition Metal Catalysts and of metalorganic reagents in C-C bond formation.
- Process understanding: route selection. – Production modes: batch, semi-batch and continuous processing and their variants. – Heat and mass transfer. – Representation of the whole process: IPO (Input-Process-Output) diagrams. – Practical process selection.
- Microscopic vs. macroscopic: the correlation between structure and properties. – Importance of first and second order asymmetric transformation in stereochemical processes. –Resolution vs. Asymmetric synthesis. – Chiral pool: identification and availability.
- Crystal forms: polymorphism and amorphism. – Crystal growth under kinetic and thermodynamic conditions. – Micro-, macro- and nano particles.
to Make Chemicals
In Custom Synthesis we provide support from the preclinical phase to Phase 4