PREMISE

The first training course, run by APIS Chem S.r.l., dedicated to chemical and pharmaceutical companies, took place in September 2017.

We are now 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 more 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.

COURSE PHILOSOPHY

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.

CONTENT

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 kinetic (2) and thermodynamic (2) 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 solvents (3), going onto explore their effects (3) and role in catalysis (4) in designing industrial organic processes (5). As today many APIs are pure stereoisomers, stereochemistry (6) and stereoselective synthesis (6) will necessarily be touched upon.

Furthermore, the course acknowledges the increasing importance of the solid state (7) 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.

INSTRUCTOR

Claudio Giordano.

OTHER SPEAKERS

External specialists may feature in order to expand upon specific topics, including solid-state chemistry, advanced physical chemistry and chemical hazard.

COURSE FEE

Provided upon request.

NOTES

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.

(1) Maximizing the number of atoms of all raw materials that end up in the product.

(2) 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.

(3) 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.

(4) 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.

(5) 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.

(6) 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.

(7) Crystal forms: polymorphism and amorphism. – Crystal growth under kinetic and thermodynamic conditions. – Micro-, macro- and nano particles.

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