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Recent News 

 

Asymchem passed Australian TGA Remote Audit

Recently, Asymchem received notification from the Australian Therapeutic Goods Administration (TGA) that it closed the Pre-Approval Inspection (PAI) audit for an API product performed by Asymchem (Jilin site). The remote audit lasted four days and was again given an A1 rating after 2017, which is the highest GMP compliance level in the current TGA system. The success of this audit shows that Asymchem’s quality management system, production management capability, can provide services for commercial product development/production in international markets.

 

Technology Updates

 

Asymchem applies immobilized ketoreductase to continuous and efficient production of optically active substances

Asymchem published a paper entitled, “Highly Efficient Production of Optically Active (R)-Tetrahydrothiophene-3-ol in Batch and Continuous Flow by Using Immobilized Ketoreductase” in the ACS journal “Organic Process Research & Development.” Based on the immobilization platform, Asymchem has successfully developed an immobilized ketoreductase with excellent long-term operational stability and space-time yield. This was successfully applied in the biosynthesis of (R)-tetrahydrothiophene-3-ol in continuous flow and batch mode. Conv.>99%, ee value 99.9%

 

Asymchem’s continuous flow synthesis method of 2-fluoromalonate diesters compounds was granted patent

The continuous flow synthesis method of 2-fluoromalonate diesters successfully developed by Asymchem, has been granted a patent (CN110437069B). The invention uses continuous flow reaction equipment to initiate the high-temperature carbonyl elimination reaction of 2-fluoro-3-oxosuccinic acid diesters. Compared with traditional batch reaction, this method has greatly reduced the safety risk because of the amount of material involved in the reaction. Per unit time is greatly reduced, which reduces the high-temperature hazardous area. The continuous flow reactor can rapidly heat the raw material to the reaction temperature. This avoids the decomposition of the raw material due to long time heating, allows more precise control of the process parameters, and significantly improves the yield. At the same time, by using the automatic control system, the reaction parameters such as temperature, pressure, flow rate, etc. can be precisely controlled and fed back in real time.
 

Clin-nov Medical Business Progress

In 2022, Clin-nov was tasked to train the Tianjin Cancer Hospital on conducting the lecture of “Drug Clinical Trial Quality Management Standards.” On April 6, Zhang Tieqiang, Director of Quality Assurance Department, brought the first GCP training on the latest version of 2020 Drug Clinical Trial Quality Management Standards. Approximately 200 doctors, nurses and technicians from all departments in the Airport Hospital actively participated in the training and learning. The training aimed to strengthen the ability of the Tianjin Cancer Hospital to undertake clinical trials, ensure standardization, safety, and data validity during the implementation of clinical trials. As well as improve the research level and regulatory awareness of clinical trial investigators and gain an in-depth understanding of the requirements related to the new version of GCP specifications.

 

Newly Joined Talent

 

Dr. Min Ge, officially joined Asymchem as Senior Vice President on April 18, 2022. He reports directly to the Chairman and CEO, Dr. Hao Hong. Dr. Ge will be responsible for the operation and management of CMMD & IAPM. This will establish and optimize the coordination management and customer communication management system of CMMD & IAPM to promote market development and expansion. This also provides strong technical support according to Asymchem’s overall business development strategic goals. Dr. Ge graduated from University of Science and Technology of China in 1993, majoring in Chemistry. He received his Master’s Degree in Chemistry from Princeton University in 1995 and his Ph.D. in Organic Chemistry from Princeton University in 1998. 1999 to 2001, he worked as a postdoctoral researcher in the Department of Chemistry at Harvard University, under Elias J. Crey, Professor of Chemistry and Chemical Biology at Harvard University, winner of the 1990 Nobel Prize in Chemistry. Dr. Ge is a member of American Chemical Society and American Pharmaceutical Association. From 2001 to 2007, he worked as a Senior Researcher at Merck. From 2007 to March 2022, he has served as Vice President and Chief Scientist of Jiangsu Zenji Pharmaceutical. Dr. Ge has published more than 30 articles in core journals such as Science and JACS, and obtained more than 40 invention patents at home and abroad.

 

Jan Jiricek, Ph.D., joined Asymchem on April 4, 2022, as Senior Director of Commercial, Business Development at Asymchem Boston. He is responsible for developing new business on the West Coast of the United States, establishing team performance standards, and tracking results to meet sales goals. As a leader, he will oversee the progress of business initiatives, create  opportunities for innovative business models, and will achieve business growth through differentiated expansion strategies. After graduating from the University of Hanover, Dr. Jan Jiricek spent a year in the laboratory of Professor Chi-Huey Wong at the Scripps Research Institute, where he successfully defended his dissertation with distinction in Professor Siegfried Blechert’s group. He initially joined the Genomics Institute of the Novartis Research Foundation in San Diego and then joined the Medicinal Chemistry Group at the Novartis Institute of Tropical Diseases in Singapore. As an experienced medicinal chemist and lecturer, Dr. Jiricek has over 19 years of drug discovery experience in the early and preclinical stages of drug research. He has published numerous papers in world-class journals such as Science, Nature Comm, Nature Medicine, JACS, J.Med.Chem, and Science Transl. In addition, Dr. Jan Jiricek has contributed to several international patents.

 

Paul Grover, Ph.D., joined Asymchem on March 1, 2022, as Senior Director of Commercial, Business Development at Asymchem Boston. He is responsible for developing new business on the East Coast of the United States; monitoring work progress, establishing team performance standards, and tracking results to meet sales goals. As a leader, he will oversee the progress of business initiatives, creating opportunities for innovative business models, and will grow the business through a differentiated business development strategy. Dr. Paul Grover received his PhD in Organic Chemistry from Indiana University, developing novel chiral boron reagents for asymmetric synthesis. After completing the first total synthesis of Microcolin A, as a postdoctoral fellow, Dr. Grover moved to Sepracor for medicinal chemistry and subsequently to business development. Dr. Grover has over 7 years of business development experience and 14 years of medicinal chemistry and process development experience.