Address: 1 Broadway, Cambridge, MA02142 (America)
Tel: +1(626)986-9880
Address: Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK
Tel: 0044 7790 816 954
Email: marketing@medicilon.com
Address: No.585 Chuanda Road, Pudong New Area, Shanghai (Headquarters)
Postcode: 201299
Tel: +86 (21) 5859-1500 (main line)
Fax: +86 (21) 5859-6369
Date: Saturday, June 3rd, 2023
Location: Boston Marriott Cambridge
Date: June 5-8, 2023
Location: Boston, MA
Booth: 2275-J
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For actual information, please refer to:www.eastmoney.com
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Business Inquiry
Global:
Email:marketing@medicilon.com
+1(626)986-9880(U.S. - West Coast)
0044 7790 816 954 (Europe)
China:
Email: marketing@medicilon.com.cn
Tel: +86 (21) 5859-1500
Our Process Department employs the principle of QBD in API process development ,and strives to select the best route suitable for our clients, optimizing the API production process to improve product quality and manufacturing efficiency.
Meet the quality requirements of laboratory scale, safety, pilot, and clinical batches, with appropriate attention to yield and process fluency.
1. Literature research, patent evaluation report.
(1) Find out as much relevant information that is already publicly available as possible.
(2) Design multiple possible synthesis routes.
(3) Evaluate whether there is intellectual property risk in the synthesis route.
2. Selection of synthesis route and reaction design
(1) Complete the design of each step and evaluate the profile, impurity spectrum, yield, and quality of each reaction step based on previously accumulated knowledge.
(2) Complete the post-treatment design of each step, including quenching, purification, filtration, and drying.
(3) RFT (Right First Time).
3. Process optimization.
(1) Comparation of before-and-after optimization and determination of "key process points."
(2) Draft preliminary quality standards for starting materials and intermediates.
4. Impurity spectrum study.
(1) A comprehensive study is not required.
(2) There should be an overview of the major impurities.
5. Analysis of the reaction mechanism.
(1) Analyze the reaction mechanism of each step and find the direction of controlling side reactions.
(2) Choose the conditions that are favorable for the primary reaction.
• DOE and Parallel reaction
Optimization of reaction conditions: reagent equivalent, temperature, concentration, reaction time, etc.
It can significantly improve the efficiency of condition optimization and get the optimal condition quickly.
• Destructive test (Stress test)
It is essential to do destructive tests for laboratory-scale batches, including the stability of starting materials, intermediates and products.
After the initial optimization of the process, it tests the applicable scope of the process.
• The Spiking experiments
Verify process performance, such as whether the spec setting is reasonable and whether impurities can be removed.