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Highlights

Technology-driven, detail-oriented and efficient: Asymchem celebrates two year anniversary of its sterile formulation platform

In 2019, Asymchem launched a one-stop service platform for aseptic formulation development and production. Since then it has successfully delivered more than 20 aseptic formulation products, completed over 30 formulation development projects while serving more than 20 clients. Asymchem’s one-stop service system for aseptic formulation includes several technical platforms:

  • Solubilization of insoluble drugs

  • Ophthalmic formulation development

  • Chemical macromolecule drug formulation development

  • Aseptic lyophilized powder injection/water injection drug development

The delivered aseptic formulation categories include aseptic lyophilized powder injection, aseptic injection, eye drops (solution/mix type), peptide drugs, and oligonucleotide drugs

 

Center of Flow & Continuous Technology (CFCT) and the Center for Intelligent Manufacturing Technology (CIMT) Established

On June 21, Asymchem’s Center of Flow & Continuous Technology (CFCT) and Center for Intelligent Manufacturing Technology (CIMT) were formally established.  CFCT covers four core areas within Continuous Flow Technology:

  • Technology service and transfer

  • Technical solution and innovation

  • Equipment design and modification

  • New application development

CIMT enables the identification of best process methodology and production control through big data analysis, integrated R&D, production logistics information, and control program output interactive verification.

 

Advanced Technologies and New Methodology focused: 2021 International Summit on Chemical Reactions in Pharmaceutical Industry

The 2021 International Summit on Chemical Reactions and Pharmaceuticals will be held in Tianjin (P.R. China) on September 17-18. This year’s summit is organized by the Process Chemistry Committee of the Chinese Chemical Society. Zhou Qilin, Professor of School of Chemistry, Nankai University, and Dr. Xiao Yi, Senior Vice President of Asymchem, are co-chairs of the conference. The conference aims to promote academic exchanges and collaboration of ideas between academia and industry in pharmaceutical process and encourage original innovation and technical cooperation. The conference will also promote the transformation of original research results and the industrial application of innovative technologies.

 

Technology Updates

Pilot Validation of Continuous Flow Reaction Device for Key Intermediates of β-lactam Antibiotics

Designed and assembled by Asymchem, β-lactam key intermediates continuous flow reaction device has been fully validated for production. The overall yield is 5% higher while production efficiency increased by 40% compared to conventional batch production process.  The annual production capacity of a single set of equipment could reach 13 MT.  The production capacity of the equipment could reach 50mt per annual if necessary. In addition, the whole process offers advantages in multiple areas such as safety and efficiency, small footprint, and stable product quality.  Since this new technology is highly automated, it results in more than 50% saving on labor costs.

Production Tests of Flow Continuous Methanesulfonyl Azide Preparation Reactor

Designed and assembled by Asymchem , the continuous flow equipment for preparation of methanesulfonyl azide preparation has been successful tested on production scale.  A single unit could process and produce 0.5 to 1.2 MT of substrate per day. The new continuous flow equipment offers advantages of optimized mixing liquid phases, simple operation, small footprint with far greater safety, reliability,  and consistent product quality compare to conventional batch synthesis.

Asymchem’s Self-developed P450 Enzyme Granted a Patent

Asymchem’s self-developed P450 enzyme was patented by China National Intellectual Property Administration (CN112359027B). Direct transformation of alkenes to the corresponding anti-markovnikov carbonyl compounds has proven difficult. It depends on precious metals performing with both low turnover numbers and regioselectivity/ enantioselectivity. The P450 enzyme and its variants were obtained by enzyme screening and evolution, which can catalyze the anti-markovnikov alkene oxidation with high activity and selectivity. The variants can be used to synthesize important intermediates and simplify the synthesis route.

Asymchem Develops a New Class of Esterases, Obtains Patent

Based on the existing enzyme library and relying on the core technology of the enzyme evolution platform, Asymchem has independently developed a new class of esterases, which have been granted a patent by China National Intellectual Property Administration (CN 112430585 B). With high catalytic efficiency and good stereoselectivity, this class of esterase has solved the problem that it is difficult to synthesize high purity chiral acid (ee value >98%) by chemical synthesis method. Additionally, it reduces waste offering a green chemistry solution.