BioCentriq: Accelerating CGT Therapies with End-to-End CDMO Solutions and LEAP™ Platform

In 2003, Gendicine was approved for marketing by the State Food and Drug Administration, becoming the world’s first approved gene therapy drug. The launch of Gendicine brought new hope to the gene therapy industry, which was then at a low ebb, and was hailed as “a new milestone in the field of genetic research and high-tech biotechnology.” With the development of new vectors and technological advancements, the nearly two decades since Gendicine’s approval have witnessed continuous breakthroughs in cell and gene therapy (CGT), with the CGT industry advancing irresistibly. According to incomplete statistics, more than 50 CGT therapies have been approved for marketing worldwide to date.

Behind the successive approvals and market launches of several cell and gene therapy (CGT) products lies the indispensable contribution of the “water sellers”—CGT contract development and manufacturing organizations (CDMOs). Compared with traditional drug development, CGT therapies entail significantly higher R&D costs. According to a report by Frost & Sullivan, R&D expenditures for CGT therapies range from $900 million to $1.1 billion during the discovery and preclinical stages, and from $800 million to $1.2 billion during the clinical stages. Meanwhile, the CGT industry faces numerous challenges, including issues with quality and batch consistency, as well as constraints imposed by high costs and pricing. Consequently, partnering with CDMOs has become a key strategy for CGT pharmaceutical companies to reduce costs and enhance efficiency, driving rapid expansion and development of the CGT CDMO market and attracting an influx of elite talent and capital.

BioCentriq is a full-service global CGT CDMO.. The company was founded in 2019 and is headquartered in Newark, New Jersey, USA,The company has established a mature quality system and modern infrastructure. Its services and solutions include process development, clinical manufacturing, and analytical testing, covering the entire lifecycle of CGT products.By providing professional, comprehensive, one-stop CGT CDMO services, BioCentriq aims to shorten the development timeline for drug candidates, reduce costs and clinical trial risks, and accelerate the delivery of effective innovative therapies to patients.

In April 2022, BioCentriq signed a definitive agreement with South Korea’s Green Cross Holdings Corporation.GC to Acquire 100% Stake in BioCentriq to Expand Its CGT CDMO Platform Capabilities and Strengthen Global Presence in the CGT Market; Transaction Valued at $73 Million (Approximately RMB 530 Million), with GC parent company contributing $53 million and its subsidiary, GC Cell, contributing $20 million.

BioCentriq, incubated by the New Jersey Innovation Institute (NJII), is the first CGT therapy development and manufacturing center established on a university campus in the United States. Within just one year of its establishment, BioCentriq formed strategic partnerships with multiple industry-leading organizations, including PALL, KYTOPEN, and Terumo Blood and Cell Technologies.

In 2020, BioCentriq constructed a GMP manufacturing facility in North America, which officially commenced operations the following year. To date,BioCentriq operates a total of 14 GMP-grade production facilities across North America and South Korea, including pilot plants, analytical method development (AMD), process development (PD), and quality control (QC) laboratories, along with supporting infrastructure., specifically including four ISO-7 certified cleanrooms for CGT therapy manufacturing, a full set of BSL-2 equipment for process development and pilot-scale production, quality control laboratories for in-process and analytical testing, as well as warehousing and training laboratories.

To date, all of BioCentriq’s manufacturing facilities are equipped with standardized equipment and have established mature quality systems and procedures. Capable of producing both autologous and allogeneic therapies using open and closed processes, these facilities provide customers across China with CDMO services and solutions covering the entire lifecycle of CGT product development.

CGT CDMO Services Provided by BioCentriq | Image Source: BioCentriq Official Website

In addition, BioCentriq has assembled a team of more than 80 engineers and scientists with extensive professional expertise to ensure the seamless translation of candidate products from the laboratory to the clinic. The company’s leadership team includes CEO James Park, who previously held leadership positions at multinational biopharmaceutical companies such as BMS and Merck, bringing rich experience in biological development, CMC and manufacturing operations, and personnel management. Mark Broadley, Vice President of Operations, has over 20 years of experience in the pharmaceutical and medical device manufacturing industries; he formerly served as Senior Director of Operations at Charles River Laboratories, where he led daily production operations for multiple CGT products. David Smith, Vice President of Corporate Development, has more than 15 years of experience in the field of regenerative medicine; he previously served as Vice President of Technical Operations at Ori Biotech, where he led the technical strategic implementation of the company’s first innovative technology in cell therapy manufacturing.

BioCentriq Core Team Members | Source: BioCentriq Official Website

To accelerate and optimize the R&D and manufacturing processes of CGT products, and to provide customers with next-generation manufacturing solutions, BioCentriq has developed an emerging process technology platform—LEAP—through collaboration and innovation.^™Platform.In June 2023, BioCentriq officially launched LEAP at the 29th Annual Meeting of the International Society for Cell & Gene Therapy (ISCT).^™Platform。

The LEAP™ platform is designed to help early-stage biotechnology companies accelerate product development and reduce the costs and risks associated with IND-enabling studies and clinical manufacturing. Building on BioCentriq’s existing assets and expertise, LEAP^™The platform offers multiple modalities, such as LEAP-NK™ and LEAP-CAR.^™、LEAP-TCELL^™、LEAP-TREG^™、LEAP-MSC^™etc. Among them, LEAP-NK^™The platform utilizes a proprietary donor cell line to increase NK cell expansion by more than 12,000-fold. Furthermore, it enables the scaling of the NK cell expansion process to stirred-tank bioreactors, thereby achieving large-scale, cost-effective production.

Data released by BioCentriq shows that,LEAP^™The platform employs validated manufacturing processes and analytical methods, capable of reducing process development and scale-up time by up to 75%, enabling a development timeline from project initiation to patient dosing within six months. Ultimately, it can shorten clinical production time by 50% while mitigating risks during clinical trials.。

Leveraging its professional technical platform and service capabilities,BioCentriq has established a strong track record in the transfer, development, and manufacturing of GMP-compliant drug products for clinical trials. It has successfully commercialized four cell and gene therapy (CGT) treatments and advanced more than 20 projects into clinical research stages.。

Furthermore, in February 2024, GC Cell, a developer of cellular immunotherapy drugs, announced that it had signed a process transfer agreement with BioCentriq. By leveraging BioCentriq’s services and solutions in cell therapy process development, analytical method development, and manufacturing, GC Cell will introduce its autologous immune cell therapy, Immuncell-LC, to the U.S. market.

BioCentriq’s professional service capabilities have garnered favor from investors.In January 2024, BioCentriq Announced the Completion of a $29.2 Million Series A Financing RoundWith this financing, BioCentriq is poised to further accelerate its innovation capabilities, providing end-to-end solutions for the development and manufacturing of cell and gene therapy (CGT) treatments. The funds will be used to enhance BioCentriq’s production facilities, drive technological innovation, and expand its team of experts, thereby meeting the growing demand for scalable cell therapy solutions.

In addition,In June 2023, BioCentriq and global biotechnology company Cytiva announced that they had received funding from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)., to further accelerate the development and innovation of CGT therapies.

Currently, the cell and gene therapy (CGT) industry has entered a phase of rapid growth. According to statistics from the American Society of Gene & Cell Therapy (ASGCT), as of the third quarter of 2022, there were 2,031 CGT pipelines under development globally, showing a quarter-on-quarter upward trend. The U.S. Food and Drug Administration (FDA) has previously stated that it expects to approve 10–20 CGT therapies annually starting in 2025, injecting significant confidence and expectation into the industry’s development. According to Frost & Sullivan projections, the global market size for CGT therapies is expected to reach $30.54 billion by 2025.

As an increasing number of cell and gene therapy (CGT) treatments gain regulatory approval and enter the commercialization phase, demand for CGT contract development and manufacturing organizations (CDMOs) among innovative pharmaceutical companies will rise accordingly, with the outsourcing trend becoming increasingly prominent. According to Frost & Sullivan analysis, the global CGT CDMO market is projected to grow from $1.72 billion in 2020 to $7.86 billion in 2025, representing a compound annual growth rate (CAGR) of 35.5%.

BioCentriq has long been strategically positioned and deeply committed to this sector. In addition to strengthening independent innovation to consolidate its core capabilities, the company is actively pursuing external collaborations, supported by a new round of financing, to enhance the professionalism and comprehensiveness of its CDMO services.

In January 2024, BioCentriq partnered with Autolomous, a developer of key manufacturing management systems for cell and gene therapy (CGT). BioCentriq will leverage digital technologies such as Autolomous’s autoloMATE platform to accelerate process development and manufacturing activities. Dr. David Smith, Vice President of Development at BioCentriq, stated, “Autolomous’s autoloMATE platform will transform our operations. By streamlining data processing throughout the entire development and manufacturing workflow, we will be able to enhance operational efficiency and flexibility while reducing risks, ultimately delivering therapeutic products to patients more rapidly.”