Tag: CMO Excellence Award

Olon S.p.A is awarded on their innovative work, “Recombinant DNA technology and chimeric protein expression for sustainable production of therapeutic peptides by microbial fermentation.” Leveraging their expertise in microbial fermentation, Olon S.p.A. has developed a flexible manufacturing platform for the synthesis of peptide therapeutics. This novel technology synthesizes peptides using microbial fermentation (rDNA expression), leading to reduced solvent and toxic material usage, as well as minimizing excess building blocks by using no protecting groups. This improves the overall PMI compared to the existing Solid Phase Peptide Synthesis (SPPS) methods. Moreover, as part of their platform, a Master Cell Bank (MCB) significantly reduces the lead time for manufacturing since the cells can be logarithmically proliferated to maximize the yield of desired product in the fermenter. They are adapting their novel Fermentation Platform towards commercial GLP-1 peptides and non-GLP-1 peptides. Olon’s novel Fermentation Platform can help address the growing global demand for peptide therapeutics while employing the principles of green chemistry. The team consists of Piera Fonte, Gian Luca Bertetti, Antonella Malcangi, Alberto Oppedisano, Mattia Stucchi, Marianna Lembo, Guido Trione, Eleonora Amante, Giuseppe Borrelli, and Giuseppe Ferrante.

More about the Award

The CMO Excellence in Green Chemistry Award seeks to recognize outstanding efforts by CMO companies in pharmaceutical green chemistry in support of pharmaceutical research, development and manufacturing that demonstrate compelling environmental, safety and/or efficiency improvements.

This annual award is presented at the Green Chemistry & Engineering Confernece where presenters are invited to share their innovations. 

2024 CMO Excellence in Green Chemistry Award

The PharmaBlock team was selected based on their innovative work on “Sustainable Manufacturing Process for Commercial and Developmental Stage Intermediates through Two Consecutive Flow Reactions using Micro-Packed Bed Technology.” Team members are Feng Zhang, Guangchao Ma, Dafen Wen, Yang Zhu, and Yuanxian Wang, all based in Nanjing, China. Their project demonstrated the use of micro-packed bed technology to produce tert-Butyl 3-oxoazetidine-1-carboxylate and tert-Butyl 3-aminoazetidine-1-carboxylate through oxidation reactions and reductive amination reactions at scale, resulting in improvements to safety, equipment volume efficiency, process mass intensity (PMI), greenness, and cost efficiency.

More about the Award

The CMO Excellence in Green Chemistry Award seeks to recognize outstanding efforts by CMO companies in pharmaceutical green chemistry in support of pharmaceutical research, development, and manufacturing that demonstrate compelling environmental, safety, and/or efficiency improvements. The award recognizes greener advances in synthetic route development for starting materials, intermediates, or active pharmaceutical ingredients (APIs), including reaction conditions and chemical or manufacturing technologies.

This annual award is presented at the Green Chemistry & Engineering Conference where a member of the winning team is invited to share their team’s innovations. 

Pictured: Wang Yuanxian, Director of R&D at PharmaBlock, accepts the 2024 CMO Excellence in Green Chemistry Award from Isamir Martinez (ACSGCI) and ACS GCIPR 2024 Co-Chair, Dan Bailey of Takeda.

2023 CMO Excellence in Green Chemistry Award

PharmaBlock Sciences from Nanjing, China, received the 2023 CMO Award for their “Innovative Continuous Process for the Production of 3-Oxocyclobutane-1-Carboxylic Acid,” an intermediate used in several marketed drugs and drug candidates. The team developed a novel continuous process to replace the conventional batch production that included an acidic decarboxylation step (Scheme 1 & 2). PharmaBlock reports that the new method is 20 times more efficient: In 10 days, using this new process, PharmaBlock produced over 2 MT with a comparative savings of 68,000 kW energy and the elimination of 8 tons of hazardous waste. In addition, PharmaBlock reduced the exposure of their chemists to potential hazards by developing a remote monitoring system to control the reaction parameters. 

PharmaBlock is continuing to work on its innovative process, which is continuous through the decarboxylation, decolorization, extraction, separation, and concentration phase, to include the final steps of crystallization and filtration. Team members on this project included Feng Zhang, Guangchao Ma, Pengpeng Chen, Bing Zhou, Wei Li, Fuxuan Wang, Hao Tian, Li Zhang, and Yuanxian Wang.

Scheme 1. Original Process

Scheme 2. New Process

PharmaBlock is continuing to work on its innovative process, which is continuous through the decarboxylation, decolorization, extraction, separation, and concentration phase, to include the final steps of crystallization and filtration. Team members on this project included Feng Zhang, Guangchao Ma, Pengpeng Chen, Bing Zhou, Wei Li, Fuxuan Wang, Hao Tian, Li Zhang, and Yuanxian Wang.

More about the Award

The CMO Excellence in Green Chemistry Award seeks to recognize outstanding efforts by CMO companies in pharmaceutical green chemistry in support of pharmaceutical research, development, and manufacturing that demonstrate compelling environmental, safety, and/or efficiency improvements. The award recognizes greener advances in synthetic route development for starting materials, intermediates, or active pharmaceutical ingredients (APIs), including reaction conditions and chemical or manufacturing technologies.

This annual award is presented at the Green Chemistry & Engineering Conference, where a member of the winning team is invited to share their team’s innovations. 

Pictured: Zhenzhen Dong, Senior Director, US Head of Business Development & Marketing for Pharmablock accepts the 2023 CMO Award with Roundtable co-chairs, Phillipa Payne (Gilead) and Dan Bailey (Takeda).

2022 CMO Excellence in Green Chemistry Award

The Inaugural CMO Excellence in Green Chemistry Award goes to Asymchem, located in Tianjin, China, for “Leveraging innovative manufacturing technologies to deliver sustainable processes: A production-scale continuous [2 + 2] photocycloaddition to prepare a key raw material.”

Asymchem developed a continuous gas-liquid biphasic photochemical cycloaddition of maleic anhydride with ethylene as a scalable and sustainable solution for the production-scale preparation of a pharmaceutically relevant cyclobutene derivative to be used as a key intermediate in an API synthesis for the partner pharmaceutical company Amgen. By working with the process design and by fabricating new equipment, Asymchem was able to reduce the number of synthetic steps by five, eliminate use of hazardous reagents, and reduce waste by 72% compared to the existing manufacturing route. 

Caption: Pictures of the production-scale photochemical skid measuring ~2m tall, capable of producing 5 kg/day of cyclobutane. Photo credit: Asymchem.

More about the Award

The CMO Excellence in Green Chemistry Award seeks to recognize outstanding efforts by CMO companies in pharmaceutical green chemistry in support of pharmaceutical research, development, and manufacturing that demonstrate compelling environmental, safety, and/or efficiency improvements. The award recognizes greener advances in synthetic route development for starting materials, intermediates, or active pharmaceutical ingredients (APIs), including reaction conditions and chemical or manufacturing technologies.

This annual award is presented at the Green Chemistry & Engineering Conference, where a member of the winning team is invited to share their team’s innovations. 

Pictured: Joshua Bolger, Senior Director of Process Chemistry at Asymchem, accepts the 2022 CMO Excellence in Green Chemistry Award from Isamir Martinez (ACSGCI) and ACS GCIPR 2022 Co-Chair, Philippa Payne of Gilead.