Asymchem expands service capability with a new project settled in Zhenjiang Economic Development Area.
On June 2, Dr. Hong and other company leaders visited Zhenjiang Economic Development Area, meeting with key government officials of Zhenjiang City and reached a cooperation agreement. Through the developmental advantages of the health industry in the Yangtze River Delta region, the cooperation enhances Asymchem’s strength as both an innovative drug R&D and manufacturing supplier. It will also improve Asymchem’s multi-dimensional business strategy and accelerate the construction of an integrated service ecosystem for innovative drugs.
From Clinical to Commercialization: Asymchem and Betta Pharmaceuticals Partnership
On June 18, Asymchem and Betta Pharmaceuticals signed a partnership agreement to supply innovative APIs in Hangzhou, China. Dr. Hao Hong, Chairman and CEO of Asymchem, Dr. Lieming Ding, Chairman of Betta Pharmaceuticals, and other representatives attended the signing ceremony. The two parties discussed and negotiated an in-depth cooperation on API R&D, production, registration, and other details. The agreement will expand the partnership to cover the clinical-stage to commercialization and bring more valuable new drugs to fulfill the unmet clinical within the pharmaceutical industry.
Asymchem promotes the application of flow reaction through modular technology
Asymchem built a flexible and practical modular technology platform for flow reaction that can be used in large-scale production with hundreds of small-scale, pilot-scale, and commercial-scale equipment platforms. Through the modular combination, automated precise control, rapid construction of reactors, screening of reaction conditions, and implementation of projects, Asymchem can meet the client’s demand for a continuous flow drug production. Asymchem has achieved the ton-level manufacturing of both key intermediates and APIs for several innovative drugs through the proficient application of flow reaction technology. This makes Asymchem one of the very few companies in the world that has extended the use of such technology to manufacturing.
Asymchem has always focused on the R&D and commercialization of green pharmaceutical technology. After a long period of cultivation and accumulation, we have not only reached the large-scale application of flow reaction technology in the production of innovative drugs, but also achieved the efficient application of the flow equipment for post-reaction treatment, wastewater treatment, etc. Currently, more than 30% of the scaled-up production for clinical mid-late stage projects have successfully implemented flow reaction and other green pharmaceutical technologies.
Asymchem’s co-authors Org. Process Res. Dev. (OPRD) | “Development and Execution of the Production-Scale Flow [2+2] Photocycloaddition”
Recently, Asymchem (stock code: 002821.SZ) co-authored a paper with Amgen Inc.-“Development and Execution of a Production-Scale Continuous [2+2] Photocycloaddition” in the academic journal of American Chemical Society (ACS) called Org. Process Res. Dev. (OPRD). This was a breakthrough in scaling up photochemical applications and was a result of a collaboration between Amgen’s Process Development Group and Asymchem’s Center for Process Sciences (CEPS). Together, we overcame the long-standing scale limitation of the traditional [2+2] cycloaddition reaction by establishing a multi-kilogram scale production system and has become a global pioneer in industry manufacturing using [2+2] photocycloaddition reaction.
Asymchem’s patent granted – “Flow synthesis-Purification device and flow reaction system
Asymchem’s “Flow Synthesis-Purification Integrated Unit and Flow Reaction System Containing it” has been granted a national patent for invention (CN210683637U). This utility model does not only improve the conversion rate of raw materials and product yield, but also increases product purity, shorten the reaction route, reduce the equipment quantity, reaction time, floor space, labor intensity and energy consumption, etc.
Asymchem’s patent granted – “Flow synthetic route of 2-chloropyrimidine-4-carboxylic acid compounds”
Asymchem’s patent “Flow synthetic route of 2-chloropyrimidine-4-carboxylic acid compounds” was granted by the National IP Administration (No. CN110642789B). It provides a continuous synthetic solution by carrying out a continuous methylation reaction with certain methyl Grignard reagent and then undergo flow oxidation producing the final target compound with a total yield of 70%. Therefore, it effectively addressed issues like high cost, low product yield, high environmental pollution in the existing preparation of 2-chloropyrimidine-4-carboxylic acid compounds, which greatly improved the reaction efficiency. The cost for product synthesis and the safety risks associated with the use of methyl Grignard reagents are beneficial for the industrial scale-up manufacturing.
Asymchem’s patent granted – “Preparation of trifluoroalkyl sulfone compounds”
Asymchem’s patent “Preparation of trifluoroalkyl sulfone compounds” was granted by the National IP Administration (No. CN110683999B). This method uses hydrogen peroxide for the continuous oxidation of trifluoroalkyl sulfide to obtain a product system containing trifluoroalkyl sulfone compounds. This invention uses a continuous feed, which improves the material contacting effect and reduces the pressure tolerance requirement for flow reactors.
Asymchem’s patent granted – “Synthetic route of fluorinated chiral amine compounds”
Asymchem’s patent “Synthetic route of fluorinated chiral amine compounds” was granted by the National IP Administration (No. CN110950788B). The route comprises an amino donor reacting with certain fluorinated dihydroxy ketal compound, catalyzed by a transaminase to produce chiral fluorinated amines, wherein the transaminase is derived from multiple strains. Such transaminase has substrate specificity and catalytic activity for a variety of fluorinated dihydroxy ketals. This patented route not only accounts for less steps, higher product yields and significantly lower production costs, but also effectively reduces the use of organic solvents and waste generation.
Asymchem’s patent granted – “Synthetic route for chiral diamine compounds”
Asymchem’s patent “Synthetic route for chiral diamine compounds” was granted by the National IP Administration (CN110982856B). Chiral diamine compounds are widely found in many biologically active natural products and drug molecules, being a research hotspot for chemists. The conventional synthetic route would use highly toxic azide compounds or cyanogenic reagents, with a large amount of wastes, which are difficult to be disposed of. The new synthetic route provided by this invention involves the biocatalytic reaction of aminotransferase, which is derived from multiple strains and has high substrate selectivity and activity. Using this bioenzyme-catalyzed synthesis of chiral diamine compounds expands the range of substrate applicability and shortens the overall route, resulting in high product yields, low production costs, and less organic solvent uses and wastes.
Recent Investment in Fixed Assets
Phase II construction of TJ3 API plant is progressing steadily
The plant covers an area of 4884m2, and the total capacity can reach as many as 91m3. The plant is divided into 6 major controlled non-classified areas (CNC) and 7 Class D areas. The CNC areas contain 200-3000L glass-lined reactors and 200L-1000L stainless steel reactors. The Class D areas include 500L-2000L glass-lined reactors and 1000L-2000L Hastelloy reactors. At present, the civil construction of the whole plant has been capped and the outdoor steel pipe frame has been installed. The expansion will further expand Asymchem’s capability of API production to meet customers’ needs for custom manufacturing of high-end APIs.
Construction of DH3 Raw material production plant will start soon
Asymchem has started the construction project of DH3 raw material production plant. The overall layout includes a pharmaceutical raw material production building and Class A & C Warehouses, in which the four-story production building covers a total area of 7700m2 and is planned to install 500-12500L of different sized glass reactors to meet the needs of various projects. The Class A and C warehouses occupy 1260m2 and 1125m2 respectively. The construction of DH3 raw material production plant will further enhance the company’s production capacity, better fulfilling the internal demand for raw materials, and effectively strengthen the supply chain management and assurance.
Construction of SH Building 8 is proceeding smoothly
The construction of Building 8 in the Jinshan Industrial Zone, Shanghai, has proceeded smoothly. The ground floor contains McAb formulation production modules, the second floor is for 200L/500L up & downstream McAb production modules, the third floor is for McAb R&D laboratories and the fourth floor is for QC analytical laboratories. At present, the validation of the second floor has been completed and the equipment performance qualification (PQ) is underway; operation qualification (OQ) for the equipment on the first floor is undergoing too. This Shanghai Jinshan project will be a strong motivation for Asymchem’s business expansion in the field of biologics CDMO, which will make new contributions to the innovative biopharmaceuticals in China.
Construction of DH1 Building 5 production projects started
To further expand Asymchem’s capability on flow production and to accelerate the scale-up application of flow reaction, we have recently launched the DH1 Building 5 production project construction. This project mainly consists of 4 new cGMP modules, of which modules 1 and 2 are planned to be equipped with a combination of batch and flow reaction equipment. Whereas Modules 3 and 4 are planned to be equipped with half batch reaction and half flow reaction equipment. This start represents a new capacity of DH1, which offers a new stage for the scale-up application of Asymchem’s flow technology, and lays a solid foundation for upcoming commercial orders in larger quantities.
TJ1 High potent API laboratory added a new negative pressure isolator
Recently, TJ1-HP104 laboratory added a 7.5m negative pressure isolator. The new equipment is expected to arrive and be installed in late July and then be commissioned in late August. The negative pressure isolator, as a hard-bodied isolator, is mainly used for contact operation of highly toxic, highly sensitized API or formulation products. Operator’s safety can be ensured through a controllable negative pressure environment while securing the product purity and cleanliness from outside contamination too. This isolator supports the preparation of high activity APIs to be efficient and ordered.
Expansion in Formulation Business
Asymchem’s speed: The solid oral dosage formulation module with imported production lines begins successful operation
To meet the increasing business demands of the global market, Asymchem built a formulation module for solid oral dosage, which meets the GMP standards of Europe and the United States, and is equipped with imported production lines. This module has been successfully put into operation now. It covers an area of about 2300m2 and is facilitated with the Alexanderwerk WP120 dry granulator, ROMACO KTP 590X multi-functional high-speed tablet press, GEA wet granulator and other world-class equipment. This module is also the first in China to introduce the UHLMANN IBC150 integrated bottling line. It has the production capability for tablets, capsules, granules, pellets, and other dosage forms, with an annual capacity of 300kg in a single batch, while the total number of batch can reach up to 900. Therefore, we can meet the high-end manufacturing needs of our customers at different stages of drug manufacturing, from registration to commercialization.
- The Second Global Conference on BioPharma Frontier Technology July 10-11, 2020 Suzhou
- 2020 China Antiviral Drug Innovation Conference July 11, 2020 Suzhou
- Chemspec Europe November 11-12, 2020 Cologne
- CPhI & P-MEC December 16-18, 2020 Shanghai