Crystal Pharmatech Launches 'First-Time-Right' Strategy with Integrated 'Polymorph + Formulation' Platform to Accelerate Global Drug Development

On August 2, CRYSTAL Pharmatech successfully held its brand upgrade ceremony and the Crystal Sky Open Day event. Marking the 13th anniversary of CRYSTAL Pharmatech and the second anniversary of Crystal Sky, Dr. Chen Minhua, Co-founder and CEO of CRYSTAL Pharmatech, stated, “After 13 years of development and more than two years of dedicated efforts in formulation, the CRYSTAL brand will officially evolve from ‘crystal form’ to ‘crystal form + formulation.’ We believe that CRYSTAL can provide internationally leading technologies and solutions to innovative drug companies in both the crystal form and formulation segments. We also look forward to being the first name that comes to mind for every small-molecule innovative drug company, whether they face R&D needs or technical challenges related to crystal forms or formulations. We will remain committed to developing the right crystal form and formulation at the outset for each new small-molecule drug, supporting our clients with greater stability and excellence, thereby accelerating the progress of new drug molecules to clinical endpoints, and helping them become the brightest stars in their respective fields.”

What were the catalysts and stories behind Crystal Pharmatech’s brand upgrade? Amidst a crowded field of domestic small-molecule formulation companies, how did Crystal Pharmatech break through the pack to become a shining star in the formulation sector?VBInsight provides an in-depth analysis of this.

▲ On-site of CRYSTAL Pharmatech’s Brand Upgrade and Crystal Sky Enterprise Open Day

“Crystal was born of crystal forms and gained fame through them.” When speaking about Crystal Pharmatech, Dr. Chen Minhua said, “Crystal Pharmatech was founded in July 2010. In our name, ‘Crystal’ refers to crystal forms, while ‘Cloud’ signifies amorphous states. The company’s English name is Crystal Pharmatech. When I left Merck & Co. in the United States in 2010 to start my own venture, I expressed the hope that one day people would refer to Crystal Pharmatech simply as ‘Crystal,’ dropping the ‘Pharmatech’ part—much like how people say ‘Apple’ instead of ‘Apple Computers.’ After 13 years of development, Crystal has built a strong reputation in the field of crystal forms, or ‘Crystal.’ Today, most clients refer to Crystal Pharmatech simply as ‘Crystal,’ and when discussing crystal forms, they often mention Crystal. Currently, we operate three R&D centers globally, located in Suzhou, New Jersey, and Toronto. Over the past 13 years, we have provided solutions for more than 2,000 new drug compounds from over 1,000 innovative pharmaceutical companies. Among the top 10 pharmaceutical companies worldwide, eight are our clients; and among the top 20 innovative pharmaceutical companies in China, 19 are our clients.”

According to Dr. Chen Minhua, the initial establishment of CRYSTAL Pharmatech aimed to build two core competitive advantages in the closely related fields of crystal form and formulation—much like forging two sharp swords. When combined, these capabilities enable the company to develop optimal crystal forms and formulations for clients’ innovative drug molecules, thereby helping them realize their maximum clinical value.

Through the top-down close collaboration and seamless integration between CRYSTAL Pharmatech’s Crystal Form CRO Division and its Formulation CDMO Division (CRYSTAL Skyline), CRYSTAL Pharmatech is capable of providing clients with comprehensive and professional CMC services. Alongside the upgrade of the CRYSTAL brand, CRYSTAL has specifically launched Mol2Med for preclinical candidate compounds.^TMThe turnkey service, primarily divided into three steps—developability assessment, API polymorph screening and selection along with pre-formulation studies, and formulation development, manufacturing, and clinical supply—is abbreviated as the “Right First Time Three-Step” solution.Developing the correct initial crystal form and formulation for each small-molecule candidate compound helps avoid clinical failures caused by incorrect early selection of crystal forms and formulations or inappropriate development strategies, thereby reducing waste of clinical time and resources.

As a CRO/CDMO enterprise aligned with international standards, CRYSTAL Pharmatech derives over 65% of its business from the U.S. market. In response to the widespread need among innovative pharmaceutical companies for dual regulatory submissions in both China and the United States, CRYSTAL has consistently prioritized internationalization in its CRO/CDMO operations. Whether in crystal form development or formulation development and manufacturing, CRYSTAL is capable of serving global innovative drug clients from either China or North America, thereby meeting each client’s global regulatory filing requirements. With its newly established clinical supply services, CRYSTAL aims to support large-scale international multi-center clinical trials through its warehouses in Suzhou or North America in the future.

In July 2021, CRYSTAL Sky (a wholly-owned subsidiary of CRYSTAL Pharmatech, also known as the CDMO Division of CRYSTAL Pharmatech) was established in Suzhou. According to Dr. Chen Minhua, CRYSTAL chose this timing to launch the “Sky” sub-brand primarily due to the significant cost advantages of domestic supply chains. Chinese R&D talent and engineers are diligent, capable of rapidly responding to client needs, and demonstrate outstanding execution capabilities—all of which are driving the global shift of CDMO capacity demand toward China. Many U.S. biotech companies believe that it is nearly impossible to outperform competitors in the fierce global race for innovative drug development, whether in terms of speed or capital efficiency, without collaborating with Chinese CRO/CDMO partners.However, at that time, there were hardly any companies in China specializing in formulation CDMO services for global innovative drug companies, particularly those with outstanding capabilities in technology and systems.The goal of establishing Crystal Cloud was to build an innovative drug formulation CDMO based in China, recognized by global innovative pharmaceutical companies, and operating at a world-class international level.

“Crystal Sky continues CRYSTAL Pharmatech’s business philosophy and its specialized R&D service and operational system, refined over more than a decade of experience,”Leveraging the “Molecule-Material-Medicine” (“MMM”) strategy, we consistently adhere to the “First-Time-Right” principle,“By leveraging the right formulation from the outset, we can advance new drug molecules to Phase I–III clinical trials and commercialization with high quality and efficiency, thereby minimizing the time and investment required for later-stage bridging studies,” said Dr. Ma Decheng, CEO of CRYSTAL Pharmatech.

Regarding the “First-Time-Right” development philosophy, discussions were held at the event on how it can pave the way for future innovation in novel drugs. According to Dr. Long Wei, Executive Vice President of Preclinical R&D at Jacobio Pharmaceuticals, there is significant variation in post-clinical progress across different projects. For slower-moving projects, there is still time to make adjustments during the clinical phase. However, for fast-track projects, any modifications would require conducting new bridging studies. Time is extremely precious for highly competitive projects. “In this context, ‘First-Time-Right’ becomes particularly crucial. Therefore, starting off in the right direction from the outset plays a pivotal role in the overall competitive landscape.”

Dr. Zhang Xiaohu, CEO of Aikon Bio, is highly optimistic about the future of the “First-Time-Right” platform. He stated that for innovative pharmaceutical companies, the primary consideration when selecting a formulation CDMO is the return on investment. Cost efficiency and rapid project completion are often mutually exclusive; therefore, companies sometimes trade time for cost savings, and at other times, trade cost for time. “Thus, I believe Crystal Pharmatech’s ‘First-Time-Right’ approach, which prioritizes rapid project completion, is undoubtedly the optimal strategy. If Crystal Pharmatech can deliver high-quality services with guaranteed timelines, it would be most welcomed by the industry.”

To ensure the effective implementation of the “First-Time-Right” strategy, CRYSTAL Pharmatech continuously optimizes and enhances its service capabilities across multiple dimensions, including technology, platforms, systems, and hardware.

CRYSTAL Pharmatech’s R&D and production base covers an area of 7,000 square meters, encompassing formulation R&D laboratories and pilot-scale workshops, analytical R&D laboratories, QC laboratories, formulation production workshops, and a clinical supply center. The production base is equipped with world-class key formulation equipment, capable of meeting the comprehensive needs for innovative drug formulation development from preclinical stages through to commercialization.

Dr. Ma Decheng introduced that CRYSTAL Pharmatech’s business primarily relies on three major technology platforms: a conventional oral solid dosage form platform centered on compression simulation as its core technology; an amorphous solid dispersion formulation platform aimed at enhancing the oral bioavailability of poorly soluble drugs and PROTACs; and a pediatric and preclinical formulation platform led by microtablet technology.

With its robust technical platform and state-of-the-art hardware instruments, CRYSTAL Pharmatech’s formulation R&D and manufacturing, as well as clinical supply services, cover all stages from preclinical to post-marketing. Its business encompasses one-stop services ranging from pre-formulation studies, First-in-Human (FIH) early-stage formulation development/manufacturing, Preliminary Marketing Formulation (PMF) mid-stage formulation development/manufacturing, and Final Marketing Formulation (FMF) late-stage formulation development/manufacturing to commercial manufacturing, post-marketing manufacturing, and clinical supply.

Within just one and a half years of its establishment, CRYSTAL Pharmatech completed the assembly of its core technical team as well as its R&D and production systems.To date, 25 projects have been signed, with 15 from China and 10 from the United States. Among all projects supported by Crystal Sky, approximately 70% are "First-in-class" innovative drug projects.ASD projects utilizing the spray drying process account for approximately 40%, with 12 GMP manufacturing batches completed and a 100% external audit pass rate.

What sets CRYSTAL Pharmatech apart is not only its technological advantages and advanced hardware facilities, but also the founding team’s immense passion for the field of pharmaceutical formulation.

Dr. Ma Decheng’s decision to leave Merck & Co., Inc. in the United States, where he had worked for 22 years and was approaching retirement, and step out of his comfort zone to embark on an entrepreneurial venture, demonstrated remarkable courage. The inception of CRYSTAL Pharmatech stemmed from a casual meeting between Dr. Chen Minhua and Dr. Ma Decheng during a break at the 2021 DIA Annual Meeting. Dr. Chen invited Dr. Ma to join forces in building China’s premier contract development and manufacturing organization (CDMO) specializing in innovative drug formulations. According to Dr. Ma, this aligned with his long-held aspiration to assemble a team based on his own vision and establish an outstanding formulation CDMO that could deliver superior services to more innovative pharmaceutical companies. He subsequently relocated to Suzhou, a thriving hub for biopharmaceutical innovation, and joined Drs. Li Feng and Chen Xiaoxia in launching their entrepreneurial journey.

“When I was at Merck in the United States, I did not have a strong sense of the changes sweeping through the industry. It was only after I came to Suzhou and immersed myself in the wave of innovative drug development that I truly understood the industry’s needs and became sincerely committed to helping innovative pharmaceutical companies,” said Dr. Ma Decheng. He believes that formulation science is an interdisciplinary field that involves not only scientific rigor but also an element of artistry. He stated that his greatest drive in his career stems from his passion for science and engineering technology, as well as the sense of social responsibility held by pharmaceutical professionals.

Beyond their passion and determination to make CRYSTAL Cloud the best, the founding team’s professionalism is beyond question.

The three founding team members of CRYSTAL Pharmatech—Dr. Ma Decheng, Dr. Li Feng, and Dr. Chen Xiaoxia—are all scientists specializing in formulation technology. They have experience at multinational pharmaceutical companiesAverage of over 20 years of experience in formulation development and management, with extensive R&D and manufacturing experience in conventional formulations, poorly soluble drug formulations, and pediatric formulations, having led, participated in, or supported the formulation development of over 100 innovative drugs and the commercialization of formulations for 19 innovative drugs.

At CRYSTAL Pharmatech, the three founding team members continue to uphold the pragmatism, intellectual curiosity, and inquisitiveness toward technological exploration characteristic of scientists. It is reported that even for projects not yet implemented, the three founders consistently participate in discussions whenever technical issues arise.The relentless pursuit of technical excellence and the down-to-earth spirit of scientists have also become the foundational ethos of CRYSTAL Pharmatech.

Meanwhile, the three founding team members are all former colleagues from Merck & Co. in the United States. Their renewed collaboration at CRYSTAL Pharmatech can be seen as another instance of the “Merck alumni” network branching out and growing stronger.

“Crystal Universe is our commitment to formulation development, reflecting our determination and goal to build a technically proficient organization that becomes a world-class CDMO in the niche sector of small-molecule innovative drug formulations. After more than two years of dedicated efforts, we are pleased to announce that our initial vision and expectations for Crystal Universe are being realized one by one,” stated Dr. Chen Minhua. “Looking ahead, Crystal Universe will leverage continuous innovation, differentiated formulation technologies, and systemic advantages to address the evolving demands and challenges of internationalization, helping innovative drug clients achieve successful new drug development at an earlier stage.”