Highlights

Asymchem’s two production bases start new production capacity delivery

Recently, Asymchem Dunhua production site completed the delivery of a new building, which is expected to add nearly 500m³ manufacturing capacity, ensuing enough capacity to support company’s heavy weight commercial projects.  It also enable Asymchem to be well prepared to ensure all other projects throughout the year.  At the same time, another API building in Tianjin production base started operation, expected to add 160m³ reactor volume, which could meet increasing API demands from customers around the world.  As demands for Asymchem’s service continues to climb, we have strategically accelerated the construction of several small molecule R&D and production sites across the country to add additional manufacturing capacity as quickly as possible. In 2022, Asymchem will further accelerate the production capacity construction, aiming to add 4 new buildings and 1000m³ batch capacity in Dunhua plant in the first half of the year, and achieve new small molecule batch capacity of more than 1700m³ in Dunhua, Tianjin and Yangtze River Delta region in the whole year, so as to double the batch capacity and protect the company’s strategic development.

Asymchem acquires Snapdragon Chemistry in the U.S., improving continuous production capability and overseas strategic layout

Recently, Asymchem Dunhua production site completed the delivery of a new building, which is expected to add nearly 500m³ manufacturing capacity, ensuing enough capacity to support company’s heavy weight commercial projects.  It also enable Asymchem to be well prepared to ensure all other projects throughout the year.  At the same time, another API building in Tianjin production base started operation, expected to add 160m³ reactor volume, which could meet increasing API demands from customers around the world.  As demands for Asymchem’s service continues to climb, we have strategically accelerated the construction of several small molecule R&D and production sites across the country to add additional manufacturing capacity as quickly as possible. In 2022, Asymchem will further accelerate the production capacity construction, aiming to add 4 new buildings and 1000m³ batch capacity in Dunhua plant in the first half of the year, and achieve new small molecule batch capacity of more than 1700m³ in Dunhua, Tianjin and Yangtze River Delta region in the whole year, so as to double the batch capacity and protect the company’s strategic development.


Technology Updates

Asymchem esterase patent granted

Asymchem’s self-developed esterase was patented by the Chinese Intellectual Property Office (CN113308450 B). Asymchem has developed a new esterase by enzyme evolution technology, which can be used for producting of chiral acid compound efficiently, the new esterase variant shows high activity and selectivity, and the ee value of product is >99%.

Asymchem’s lipase mutant and its application technology were granted a patent

Asymchem’s lipase mutant and its application technology were granted a patent (CN113502281B). The lipase mutant, which has changed protein structure and function compared with the parent lipase, solves the problem of low stereoselectivity of industrial lipase in the prior art. In practical application, the stereoselectivity of the lipase mutant is greatly improved, and to a certain extent, the amount of enzyme is reduced and the difficulty of post-processing is reduced, which makes it more suitable for industrial scale up production.

Asymchem published a paper entitled “Engineering a Transaminase for Efficient Synthesis of Rimegepant Key Intermediate” in OPRD

By applying artificial intelligence-assisted protein engineering modification and multiple evolutionary strategies, Asymchem has successfully developed a transaminase that can efficiently catalyze the synthesis of large-site blocking chiral amines, which is applied to the biosynthesis of key intermediates for the treatment of migraine drugs, and the obtained products have high DE values (>99%) and yields (>80%), demonstrating the company’s strong strength in the field of new green chemistry technologies.

Joint development of commercial-Scale trifluoromethylation of 2-chlorobenzenethiol with AbbVie

Recently, Asymchem published the paper “Commercial-Scale Visible-light Trifluoromethylation of 2-Chlorothiophenol using CF3I gas”. Researchers at Asymchem and AbbVie have investigated the principles of continuous photochemical reactions and developed a visible-light-catalyzed production process for the commercial-scale trifluoromethylation of 2-chlorothiophenol, successfully synthesizing over 500 Kg of high-purity product compounds with improved reaction yields and spatial and temporal efficiencies. This achievement is the first large-scale production of photo-redox reaction in pharmaceutical and fine chemical fields, and is another breakthrough in the field of continuous photochemical scale-up production by Asymchem, which is of great significance and commercial value.

 


Fixed Assets Investments

Asymchem TJ sites construction continues on schedule

  • The construction project of Asymchem TJ plant is progressing in an orderly manner. Among them, 20% of the TJ West Biofermentation Plant project is completed, along with the completion of R&D center in the north area and the framework of the multifunction. About 60% of TJ CMMD plant design is completed, and the design documents are going through its approval process; the new HP R&D laboratory in TJ is already in use, and three other HP isolator GMP production lines are under construction and expected to be put into use by the end of May. The design completion ratio of TJ3 north side plot is 40%, the comprehensive building and R&D center have been roofed; the completion ratio of nucleic acid joint venture factory project is 15%, the main body of R&D center and the main body of comprehensive building have been poured. The completion of the above plants will help the Group to continuously increase production capacity, improve operational efficiency and better meet the needs of global clients

 


Newly Joined Talent

Dr. Fang Gao officially joined Asymchem as Vice General Manager of AsymBio (Head of mRNA business) on 1st February, 2022, reporting to AsymBio CEO Rui Yang (cc AsymBio CTO Dr. Kai Gao). He will lead the overall capacities building including process development and manufacture, and undertaking service orders etc. Responsible for the process development and validation of related products, support the development and validation process of analytical methods. Responsible for the daily operation of the manufacture facilities and the management of laboratory team. Support preclinical and clinical research, including project feasibility analysis, participate discussion on mRNA CMC development strategy with customers, etc. To provide technical support and facilitate the discussion with regulatory authorities during review process of clients’ portfolio development. Work closely with business team, communicate with customers, and expand business, promote the company’s business.

Dr. Fang Gao received his Ph.D. in Cell and Molecular Biology from the University of Essex in 2006 and then joined the National Institute for Biological Standards and Control (NIBSC)/Medicines & Healthcare products Regulatory Agency (MHRA), UK, as Senior Scientist to Principal Scientist in the Physico-Chemical Analysis area. He has extensive experiences in analysis of biologics, regulation, quality control, and standard development. He has been the regulatory leader of various innovative vaccines’ approval and lot release. In addition, he has led several international collaboration projects, established nine polysaccharide International Standards for the World Health Organization (WHO), and drafted guidance documents. Dr. Gao published a number of scientific papers in the area of vaccine quality control, biological standard development, characterization of polysaccharides, vaccine stability and immunogenicity. Please join us to welcome Dr. Fang Gao to the Asymchem family and wish him all the best in Asymchem and assist Asymchem to achieve more success in the rapidly evolving biopharmaceutical market.