Upon returning to the Boston area after a number of years away, I was very much looking forward to attending The Northeastern Section of the American Chemical Society (NESACS)’s Advances in Chemical Sciences “Bench to Plant” Symposium for the first time. Held in Cambridge on October 22, about 100 scientists from the local area gathered for the one day Symposium focusing on Process R&D Chemistry, Organic Synthesis, and New Synthetic Methodology.
Some highlights of the top-notch presentations included:
This is the first blog post in a 2 part series in which I will discuss the real-time monitoring of bio-based chemical synthesis.
Biocatalysis continues to evolve, with the application of recombinant organisms or isolated enzymes designed to catalyze specific chemical reactions – often with highly regiospecific and stereospecific conversions. In the optimization of any chemical synthesis reaction – by traditional or biocatalyzed routes – it is not enough to simply report the yield and the enantiameric excess (ee), the kinetics of the reaction must also be considered. Understanding how the kinetics are affected by conditions such as pH and temperature allows optimization of biocatalysis through the identification of operating conditions that can ensure a maximum yield and desired ee in a timely manner. Continue reading →
Last week, I had the opportunity to attend the BioProcess International Conference in Providence, RI. Many of the sessions I attended highlighted the advancement of the Bio-Pharmaceutical industry in applying the principles of Quality by Design (QbD). Continue reading →
“The use of the QbD approach throughout the life-cycle of a drug product is an efficient tool for faster and more focused process development”
The paper describes the use of various tools, including:
Phase diagrams for a complete understanding of system thermodynamics, and determination of operating conditions to ensure production of the desired anhydrous form
The use of factorial design of experiments to map the operating design space, understand the effect of process variations and ensure robust operation
Real-time monitoring of the crystal product with FBRM (focused beam reflectance measurement) to monitor crystal nucleation and growth for optimization of seeding protocol and detection of undesirable events upon scale-up
In-line Raman to detect the presence of a metastable undesirable solvated form of the API, and to confirm its complete conversion to the desired stable form