CellStore Bio: Disrupting Conventional Cryopreservation with Ice-Control Technology for Safe and Efficient Universal Sample Storage

In the field of cryopreservation of biological samples, the greatest challenge to achieving high-fidelity and viable sample preservation is how to prevent irreversible damage to organelles, cell membranes, DNA, and other cellular components caused by ice crystal formation. The traditional technical approach has been vitrification, a technique used for over 60 years, which involves adding cryoprotectants such as dimethyl sulfoxide (DMSO) to induce a glass-like state in the liquid at low temperatures, thereby inhibiting ice crystal formation and protecting cells from damage.

However, complex samples and fragile cells are difficult to vitrify, and vitrification cryopreservation cannot completely prevent ice crystal formation. Furthermore, dimethyl sulfoxide (DMSO), a common vitrification cryoprotectant, is inherently toxic and poses certain risks for downstream applications; for instance, its use in assisted reproductive technology has been associated with higher miscarriage rates in in vitro fertilization pregnancies. While alternative vitrification cryoprotectants such as ethylene glycol and glycerol can be employed, their cryopreservation efficacy is significantly reduced.Therefore, traditional technologies have always been unable to achieve both “high efficiency” and “safety,” a limitation inherent in the nature of conventional technological approaches.

CellStore is an innovative enterprise dedicated to the research, development, and production of next-generation safe cryopreservation solutions for biological samples. By investigating the ice-control mechanisms and principles of antifreeze proteins, CellStore has developed a new generation of safe cell cryopreservation media based on ice recrystallization inhibition. The principle of ice-controlled cryopreservation does not involve inhibiting ice crystal nucleation, but rather suppressing the growth, morphology, and size of ice crystals.Therefore, controlled-rate freezing does not rely on vitrification and can theoretically achieve cryopreservation of any sample; for stringent application requirements, DMSO-free cryopreservation is also feasible.

Dr. Sun Yuling, CEO of CellStore, told VCBeat: “Our technology is disruptive; this is not overtaking on a bend, but changing lanes to overtake.” Yet, what arouses our curiosity even more is the source of this entrepreneur’s confidence and passion, and what new chapter CellStore will lead China’s cell cryopreservation industry to open.

This dialogue begins with the founding of CellStore. In May 2022, Professor Wang Jianjun, a materials scientist specializing in ice-controlling materials, recipient of the First Prize in Natural Sciences from the Beijing Municipal Science and Technology Award, and researcher at the Chinese Academy of Sciences, together with Dr. Sun Yuling, a postdoctoral fellow at the Max Planck Institute for Polymer Research in Germany and holder of a Ph.D. in Materials Science from the Department of Chemical Engineering at Tsinghua University, Dr. Huang Xiaodan from the Chinese Academy of Sciences, and other experts in related fields, jointly established CellStore in Beijing.

As a scientist-founded enterprise, CellStore’s greatest advantage lies in its profound scientific research foundation, which Sun Yuling also describes as “a decade of sharpening the sword.”

From a technological development perspective, Wang Jianjun’s team began work on “extracting antifreeze proteins from dozens of animal and plant species” as early as 2010. By 2012, through studying the ice-control mechanisms of antifreeze proteins, the team discovered that these proteins can bind tightly to the surface of ice crystals and effectively regulate their growth, thereby reducing potential damage to cells and tissues during freezing. In 2016, these research findings were published in the Proceedings of the National Academy of Sciences (PNAS). Subsequently, based on biomimetic principles and targeting the distinct characteristics of various antifreeze proteins, the team screened different ice-controlling materials capable of mimicking the mechanisms of antifreeze proteins from pharmacopoeial sources, establishing an “Ice-Control Material Library.” As the research progressed, in 2019, Wang Jianjun’s team published results in Nature, providing the first experimental confirmation of the existence of critical ice nuclei during water freezing, as well as their size and dependence on supercooling temperature.

“It follows a completely different path from the traditional vitrification cryopreservation mechanism; it is not an exaggeration to describe it as ‘disruptive,’” said Sun Yuling. The “disruptiveness” of the novel controlled-ice cryopreservation technology lies in two aspects:1. Achieve controllable ice crystal formation.In terms of morphology, the formation of sharp ice crystals is avoided; in terms of size, ice crystals can be controlled to be less than 300 nm, with their size remaining stable for 2 hours, thereby ensuring no cryoinjury during cell recovery.Second, it is safe and efficient.Independent of traditional vitrification techniques, enabling effective cryopreservation of complex samples and fragile cells; free from vitrification cryoprotectants, thus achieving DMSO-free cryopreservation and significantly enhancing safety.Controlled-rate freezing is the world’s first cryopreservation technology that simultaneously meets the requirements for “high efficiency” and “safety,” theoretically enabling the cryopreservation of any sample.

Sun Yuling told VCBeat,Controlled-Rate Freezing and Cryopreservation Technology: A Decade of Refinement to Establish a Complete Theoretical Framework. It was not until 2019 that the team felt confident enough to begin preparing for the commercialization of their achievements. However, they were in no hurry to establish a company at that time; instead, they spent another three years laying the industrial foundation.

On one hand, it involves the founder’s self-cultivation. Dr. Sun Yuling, with a pure technical background, earned her Ph.D. from Tsinghua University in 2017 and subsequently conducted research on polymer materials at the Max Planck Institute for Polymer Research in Germany. Upon deciding to launch her startup, she began visiting numerous company founders and investors to gain market insights and learn about product commercialization processes. On the other hand, it concerns the company’s production capacity readiness. The team has successively established a comprehensive pharmacopoeia-compliant excipient-controlled ice material library and a GMP-certified workshop, aiming to ensure stable, high-quality production of its all-pharmacopoeia-compliant controlled-ice cryopreservation solution.

From another perspective, the well-prepared team has also completed the closed loop of “from technical confidence to entrepreneurial confidence.”Leveraging its independently developed controlled-rate freezing and cryopreservation technology platform, CellStore Biotechnology is capable of researching, developing, and manufacturing a range of cryopreservation solutions formulated with fully pharmacopeial-compliant ingredients. These products are free of DMSO, serum, proteins, and animal-derived components, thereby overcoming the limitations of vitrification-based cryopreservation and significantly enhancing cryopreservation efficacy, efficiency, and safety.

In 2021, after returning from Germany, Sun Yuling conducted market research for a period to determine the positioning and product layout of CellStore. She told VCBeat that CellStore focuses on the high-end cryopreservation medium market, with its business mainly divided into two directions: one is the sales of ready-to-use cryopreservation medium products for research and therapeutic grades; the other is providing CRO custom development services related to the cryopreservation process, such as customizing cryopreservation media for companies with cryopreservation pain points like CGT (Cell and Gene Therapy).

Regarding this business layout, Sun Yuling specifically highlighted two key points:One is to have a comprehensive product portfolio, and the other is to ensure rapid product iteration.

Let's start with the product category.CellStore has established a pipeline of 15 products, covering five application areas: immune cells, stem cells, engineered cell lines, germ cells, and tissue and organ cryopreservation.In the field of cell therapy, CellStore has developed a specialized portfolio of cryopreservation solutions tailored to various subtypes of immune and stem cells, including products for PBMCs, αβ-T cells, stem cells, γδ-T cells, NK cells, and iPSCs. While ensuring safe and efficient cryopreservation, its key performance parameters—such as post-thaw viability and live cell recovery rate—surpass those of dominant foreign brands. Notably, effective cryopreservation of fragile cell types such as NK cells, iPSCs, and γδ-T cells has remained a challenge both domestically and internationally. CellStore’s corresponding products have significantly enhanced cryopreservation efficacy, achieving a groundbreaking 0-to-1 technological breakthrough in these areas.

In addition, CellStore has established a product pipeline targeting the assisted reproduction sector, including cryopreservation solutions for oocytes/embryos and sperm, to achieve safe and efficient cryopreservation of human germ cells. Furthermore, CellStore is investing in R&D for the preservation and cryopreservation of large-scale samples such as tissues and organs. “Regenerative medicine is entering a period of robust growth, with its two core domains—assisted reproduction and tissue/organ transplantation—demonstrating strong momentum toward broader expansion,” stated Sun Yuling.

Taking assisted reproductive technology (ART) as an example, according to statistics and forecasts from QY Research, the global ART market sales reached $28.2 billion in 2023 and are projected to reach $38.1 billion by 2030. Among these advancements, safe and efficient cryopreservation technologies for oocytes, embryos, and sperm have provided infertility patients with greater hope and more options for conception, while also driving deeper progress in reproductive medicine research.

It is understood that,CellStore’s oocyte/embryo cryopreservation solution is currently in the Class III medical device registration phase, with clinical trials expected to commence in the fourth quarter of 2024, while its sperm cryopreservation solution has already finalized its formulation.

From the perspective of product iteration, after CellStore’s first-generation cryopreservation solution was launched in April 2024, its R&D team completed the update and iteration to version 2.0 in just 45 days. This robust R&D capability ensures product leadership, enabling CellStore to maintain strong market competitiveness for its offerings.

In addition, CellStore places significant emphasis on applying for various qualifications. Currently, CellStore’s cryopreservation solutions have obtained multiple U.S. FDA Drug Master File (DMF) registrations and Class I medical device filings in China, with two products having completed the classification determination for Class I medical devices.It is also the first company to have its DMSO-free cryopreservation solution included in the National Medical Products Administration’s Catalogue of Medical Device Classifications, earning widespread recognition from national authorities and industry experts.

In fact, the rapid advancement and iteration of products are inseparable from the strategic team structure behind them. Currently, CellStore’s biological team has grown to approximately 40 members, bringing together professionals across key functional areas, including R&D, regulatory affairs and quality assurance, production, sales and marketing, human resources, and finance. It is reported that in the second half of 2024, the company will continue to expand its sales and marketing teams, aiming to achieve breakthroughs in its business operations.

By the end of 2022, CellStore Biotechnology, which had been established for less than seven months, successfully attracted interest from multiple renowned investment institutions and smoothly completed its angel round financing amounting to tens of millions of yuan. In 2023, CellStore Biotechnology once again secured tens of millions of yuan in its Angel+ round of financing.

It is understood that the funds from these two rounds of financing will be primarily used for the development and production of cryopreservation solutions based on controlled ice nucleation technology, as well as for filing related regulatory approvals. These products include cryopreservation solutions for immune cells, stem cells, assisted reproductive technologies, and tissues and organs.

For Sun Yuling, corporate financing is not about “raising money for the sake of raising money.” “In the process of seeking investors, entrepreneurs need to look for those who share their vision and can grow together, much like finding a suitable partner,” said Sun Yuling. Financing is not merely a process of acquiring capital; it is also an opportunity for resource integration and collaborative synergy. Therefore, when selecting investors, she did not limit herself to a few firms but carefully chose multiple co-investors, forming a diversified investor group.

As a global leading provider of cell cryopreservation solutions, the company has maintained rapid growth over the past two years.In the future, CellStore will focus on overcoming cryopreservation challenges for various complex sample types, building an efficient and reliable cold-chain logistics platform.This platform not only addresses the technical challenges of long-term biospecimen preservation but also connects the entire biopharmaceutical industry, fostering close collaboration and resource sharing across the upstream and downstream segments of the industrial chain.

As the technology continues to mature and find broader applications, CellStore is poised to widely empower the biopharmaceutical industry with the world’s most advanced cryopreservation technologies, driving the sector toward higher levels of development.

Achieving this goal also requires the power of capital.Currently, CellStore has launched its Pre-A financing round.Sun Yuling told VCBeat that they are seeking like-minded investors to jointly address the cryopreservation of large organs, thereby facilitating the development of regenerative medicine.