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CIO Bulletin
At Asymchem the team is proud of the strides that it has made since its founding in 1999, providing R&D and one-stop production services to the world’s top pharmaceutical companies. Driving Asymchem’s success is its commitment to continual optimization and investing in the future. By improving the capabilities that partners need now, and maintaining the agility needed to support innovation, Asymchem has built a knowledge and experience base that it is ready to share. Whether it is supporting emerging biotech companies or smaller, specialty pharma, the company’s mission remains to accelerate the launch of new drugs, providing one-stop CMC services for the full lifecycle of drug development.
Asymchem’s solutions range from early clinical stage to commercial stage, including R&D and cGMP production of advanced intermediates, APIs, formulations, as well as clinical research services. Through strategic partnerships and calculated business growth, Asymchem has built an integrated service ecosystem.
Experience Gives You an Advantage
No capital investment for a new physical plant and no need to hire additional chemistry synthesis employees.
Realizing the potential of small molecules requires planning, specialized techniques and precise equipment. At Asymchem the team provides all that and more at scales ranging from milligram to metric ton quantities. That means that without significant capital investment or hiring, small biotech and specialty pharmaceutical companies can access the same advantages and regulatory oversight as big pharma.
Asymchem offers rapid, cost-effective access to small molecule expertise in the following areas:
Multi-prong Approach Minimizes Risk
Highly Potent Active Pharmaceutical Ingredients (HPAPIs or HPAIs) present many challenges due to the complex handling required for toxic substances. Asymchem’s dedicated cGMP and non-GMP HPAI compound production sites include specialized facilities for common potent compound as well as specialized classes such as (β-lactams). In addition, Asymchem has designed its equipment and facilities for maximum flexibility and developed processes to eliminate contamination vectors, such as differential pressure cascades and primary decontamination stations within suites. Rigorous qualification, maintenance of facilities, processing equipment, and continual employee training on best practices ensures compliance to Asymchem’s stringent cGMP and EHS requirements. This multi-pronged approach tackles the complex challenges inherent with HPAI handling and ensuring safety and quality.
Pioneering Advances to Address Safety & Sustainability
Asymchem has supplied both the branded and generic global carbapenem markets since 2011. In addition, the company has supported carbapenem API’s in late stage clinical development. To address safety and environmental issues, Asymchem has developed novel continuous flow technology, effectively surpassing the antiquated technology of typical suppliers. As a result, today Asymchem produces 4AA — a critical raw in imipenem, ertapanem, meropenem, doripenem — and the enol phosphate intermediate (ertapenem, meropenem).
As key players in biological processes, glycans are essential to biomedical innovation and much small molecule drug manufacturing. Asymchem’s Chemical Macromolecule Division (CMMD) glycans technology platform provides custom glycans development and manufacturing of these key components including dextran, cyclodextrin derivatives, and dextran/metal complexes. Coupled with Asymchem’s peptide, oligonucleotide, polymer, and biotransformation capabilities, this allows access to oligosaccharides, peptidoglycans, and an ever-expanding range of drug conjugates. To date, Asymchem’s glycans offerings have supported drug delivery systems, medical devices and excipients. The company has the capacity to produce GMP product from grams to multi-kilograms. Asymchem’s team can provide expert documentation preparation service to support IND/NDA filing.
About the leader behind the success of Asymchem in his own words
“In 1999, when I started Asymchem with a single laboratory in North Carolina’s Research Triangle Park (RTP), I did it with not much more than my unbridled enthusiasm for chemistry. Fortunately this period of steadfast faith in therapeutics coincided with the budding Chinese CDMO industry. In 2000, through careful consideration and investment, Asymchem extended its fast-growing operations to China and the story began to unfold. Today Asymchem employs more than 5500 people at eight sites and count as our clients as the world’s top pharmaceutical companies. While I’m proud of such a significant accomplishment, our numerous advances in novel technology including the commercial-sized application of flow chemistry in API manufacturing have fueled my continued passion for chemistry. Along with the recent construction of Asymchem’s multidimensional service platform, we’ve realized that our enriched expertise and commitment to innovation can extend beyond “big pharma” to those newly emerged biotech labs and even smaller sized specialty pharmaceutical companies adopting cutting-edge therapeutics. Using the “Know How” spirit, Asymchem has made it our mission to help these innovators successfully bring their products to market.”
Dr. Hao Hong, CEO, Chairman
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