Rui Yang, COO of Asymchem Group: A fierce leader guiding the company to become a global leading pharmaceutical outsourcing service enterprise

Asymchem Group is proud of the strides that it has made since its founding in 1999, driving its success is the commitment to continual optimization and investing in the future. By improving the capabilities its partners need now, and maintaining the agility needed to support innovation, the company has built a knowledge and experience base that it is ready to share. Its 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.

Its eight R&D and manufacturing sites are located in P.R. China and are regularly inspected by regulatory bodies such as the USFDA. Its expertise lies in developing and applying innovative technologies such as green chemistry for scaleup of technically complex API's, with the added advantage of in-house raw materials'​ manufacturing to control availability and lead-times. From initial development of a synthetic chemical process through to manufacturing, Asymchem’s proven team of experienced process and engineering teams has the knowledge to help its clients get things done.

API solutions: No Molecule Left Behind

Asymchem is a one-stop partner with unmatched know-how to support the development and manufacture of your drug substance. They offer rapid, cost-effective access to APIs and Intermediates, state-of-the-art clinical and commercial manufacturing facilities, and comprehensive process, analytical and regulatory services across every stage of the product life cycle. Simply, no other CDMO can help you get your product to market with greater speed, less bureaucracy, or better cost-efficiency. 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 they provide 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.

Pioneering Advances to Address Safety & Sustainability

Asymchem has supplied both the branded and generic global carbapenem markets since 2011. In addition, they’ve supported carbapenem API’s in late stage clinical development. To address safety and environmental issues, they have developed novel continuous flow technology, effectively surpassing the antiquated technology of typical suppliers. As a result, today they produce 4AA — a critical raw in imipenem, ertapanem, meropenem, doripenem — and the enol phosphate intermediate (ertapenem, meropenem). Everything about their Highly Potent Active Pharmaceutical Ingredients (HPAPIs or HPAIs) compounds capabilities is designed to reduce the risk posed by these toxic substances. Their facilities focus on both GMP and non-GMP configurations, including common potent compound classes (β-lactam). They have configured their equipment to maximize flexibility and developed processes to eliminate contamination vectors, like pressurization. Plus their primary decontamination stations within suites are situated to make sure that they maintain qualification by continually training employees on best practices.

Analytical Techniques and Tools to Move Development Forward

Asymchem understands that early phase work focuses on learning as much as possible about a drug compound. Their experience across numerous chemical classes and multiple dosage forms, and their ability to develop analytical methods to assess chemical identity, purity, compatibility, and stability, makes them a natural choice for this preformulation work. Their in-depth knowledge of the compound from preformulation guides them in designing manufacturing processes that control the product’s quality attributes, ensuring the product meets its Quality Target Product Profile (QTTP).

They offer a full spectrum of analytical techniques and tools, from XRPD to proton and carbon NMR, from mass spectrometry to hygroscopicity testing. In addition, their broad experience with many diverse classes of drug substances and multiple drug product dosage forms has increased their expertise around chemical compatibilities, degradation pathways, stability, and the tools to investigate these areas.

Developing and Optimizing Successful Formulations

From initial API characterization and early solid dose evaluation, Asymchem covers all the bases. They use QbD and DOE to develop and optimize formulations and solid dosage forms for robust manufacturing, with an eye towards eventual NDA filing and process validation. Thorough product knowledge and understanding is the goal.

Asymchem produces smaller early-phase clinical supplies, and can scale up to larger later-phase trials, and eventual commercial-scale production. Asymchem offers full validation support, and has much experience with technology transfers, if client decides to transfer commercial production elsewhere.

• Chemical characterization of dosage forms, including impurities, stability, excipient compatibility
• Physical characterization/development of solid bulk properties—particle size, density, flowability, compressibility—for robust downstream processing
• Tablet development, including multiple dosage sizes, sustained release, enteric coatings; and characterization, including hardness, friability, and dissolution profiling
• Formulation development for poorly soluble APIs, and spray-drying and micronization capabilities to improve solubility.

From pre-formulation, formulation development, process development and clinical supplies to commercial production of sterile solution and sterile lyophilized powder, Asymchem is ready to help. They specialize in the solubilization of poorly soluble drugs as well as sterilization either by aseptic processing or by terminal sterilization. The firm can deliver the final drug product in vials or ampoules, depending on the best option for your API and intended use. Their first-in-class integrated sterility and quality assurance systems can fully support your supply manufacturing quality and GMP compliance. In addition, their state-of-the-art analytical lab enables them complete in-house testing capability including microbial and particulate testing, as well as extractable and leachable testing for material compatibility.

About | Rui Yang

Ms. Rui Yang serves as Chief Operating Officer of Asymchem Laboratories (Tianjin) Co., Ltd. She earned an Executive MBA from Beijing University. While there, she was selected as a member of the first batch of the “New Entrepreneur Cultivation Project”. Ms. Yang trained and studied in Babson College, Massachusetts, USA as representative of “XiaoJuRen leading enterprise” in 2013. Ms. Yang joined Asymchem in 1999, and since then she has successively served as Office Director, Vice President, Executive Vice President, Executive Vice President, Executive Senior Vice President and now as Chief Operating Officer. Over the past 20 years, Ms. Yang has accumulated experience in group financial management, human resource management, project management, market exploration and public relationships. She has coordinated the activities of seven subsidiaries of the group enabling them to operate and flourish.

"Asymchem’s ability to identify and provide solutions to difficult challenges, while maintaining outstanding quality under aggressive timelines, has distinguished Asymchem as a top-notch Contract Manufacturing Organization."