SHANGHAI,Sept. 2,2024 -- Frost & Sullivan released a report,titled "BiBo Pharma: A Global CDMO Leading in Advanced Biopharmaceutical Manufacturing Technologies". The report explores a global CDMO leading the "The Fourth Revolutionary Wave of Biologics Manufacturing" and pioneering the next generation of CDMO models.

The global biomanufacturing capacity gap and budget constraints have ignited the "The Fourth Revolutionary Waveof Biologics Manufacturing",with production sites expanding towards million-liter scales. In this context,Contract Development and Manufacturing Organizations (CDMOs) have become key players in global biomanufacturing. In 2023,BiBo Pharma,founded in Boston,USA,introduced a new generation of ultra-large production platforms,marking a new era in biomanufacturing. BiBo Pharma is breaking capacity barriers and reducing antibody drug production costs from the international average of hundreds of dollars to just $10 per gram,offering disruptive solutions to global biopharmaceutical companies.

Part I: BiBo Pharma 1.0 : Reflecting on the Past - Originating in Boston,and Navigating through the Global CDMO development Journey

In the increasingly competitiveCDMO industry,BiBo Pharma continues to advance. This success is due not only to their precise grasp of market opportunities but also to their breakthroughs in core biopharmaceutical industrialization technologies. Sailing from Boston,BiBo Pharma has been committed to the commercial production of biologics since its inception. The company independently designed and manufactured the ultra-large stainless steel bioreactors and pioneers a new generation of production models. In 2023,BiBo Pharma successfully completed the construction of a 30,000L single-tank ultra-large-production line,and in March 2024,it successfully commenced operations.

BiBo Pharma developed a comprehensive technology platform for microbial fermentation,mammalian cell culture,gene therapy,and antibody-drug conjugates (ADC). This platform offers one-stop services from DNA to IND/BLA and large-scale commercial production. To date,BiBo Pharma has offered CDMO services for more than 130 large molecule projects. Their operations adhere to international quality and management standards,solidifying BiBo Pharma's position on the global CDMO stage after a decade of dedicated effort,and pioneering the next generation of CDMO models.

Part II: BiBo Pharma 2.0: Current Focus - Upgrading Strategies and Expanding Capabilities

//30,000L Capacity Advantage and Global First Delivery Advantage as an Industry Pioneer//

Major globalCDMOs are expanding their large-scale commercial production capacities by focusing on the construction of large-scale stainless steel bioreactors. The future direction involves advancing from the current 15,000L reactors to fourth-generation ultra-large-scale production technologies.

BiBo Pharma is the first and only CDMO to deliver a new generation of ultra-large stainless steel bioreactors with a maximum working volume of 30,000L per tank. This is an engineering scale-up of over 2.5 times compared to the current 15,000L (total volume) standard in large-scale biopharmaceutical production. BiBo Pharma leverages economies of scale and cost-sharing to offer a potential solution to reduce costs on the basis of ensuring independently designed core equipment and a controllable supply chain.

PanFlex®-Engineering: Breaking Through the "Quality-Cost-Efficiency" Triangle

The conventional factory construction process adopts an engineering design model that proceeds from the top level down to the lower levels.PanFlex®-Engineering employs a "Process is King" strategy,using standardized units to reverse-engineer a complete factory. As a result,PanFlex®-Engineering system transcends the impossibletriangle of "quality-cost-efficiency." Remarkably,it took less than 18 months to deliver a 30,000L ultra-large production platform,roughly half the time and cost of similar projects worldwide. In addition,the 30,000L platform passed quality audits from the U.S.,EU,and Chinese clients. Leveraging its PanFlex®-Operation system,Bibo Pharma achieved a "Right on First Time" in March 2024 when the platform was put into operation with a 100% success rate in subsequent production.

Grand-CHO Platform: A "Three-in-one" Approach to Innovation

A "Three-in-One" approach to innovation——Grand-CHO Platform involves advances in cell line development,process research,and production technology for ultra-large-scale platforms.

Grand-CHO platform improves cell line expression and stability,optimizes commercial production processes of different scales,and offers other benefits. The second-generation Epic-CHO cell line achieves a high expression level of 10 g/L at the mini-pool stage and offers more than double the stability of leading international cell lines,laying a solid foundation for large-scale production.

Grand-CHO technology enables high-density and large-scale cell storage,while seamlessly integrating a 3,000L N-1 perfusion process and a 30,000L intensified Fed-batch production process. Compared to traditional methods,Grand-CHO technology reduces production cycle time by 30%,doubles the yield per fermentation volume,and cuts restart time for 30,000L projects from 60 days to 30 days. Grand-CHO technology,integrated with the 30,000L ultra-large-scale production line,is fundamentally transforming the overall production efficiency of biopharmaceuticals.

Pulse Continuous Manufacturing (PCM)

The combination of BiBo Pharma's PanFlex®-Engineering and Grand-CHO technology has led to a groundbreaking production model —Pulse Continuous Manufacturing (PCM). PCM releases a single high-volume batch upstream,such as 60,000 liters per pulse (60kL/P). It then processes multiple downstream batches continuously based on each unit's operation time. PCM significantly improves production efficiency,boosting overall line efficiency by 50% to 300%. PCM's success is driven by the interconnected equipment enabled by PanFlex®-Engineering.Additionally,BiBo's P03 plant has implemented an automated process control system (PAS) that enables full digital integration across the facility,making the execution of the PCM model more efficient and seamless.

Technology Integration Drives Reduction of Antibody Drug Production Cost to $10 per Gram

The primary initiative to solve the constraints of production costs,is the international breakthrough of the first-ever 30,000L single-tank ultra-large-scale production line. Integrating PanFlex®-Engineering,Grand-CHO technology,and a pulse continuous production mode,BiBo Pharma reduce antibody drug production cost from hundreds of dollars to $10 per gram.

An Engineering and Technical Service Provider

BiBo Pharma has launched the pioneering "Blue Whale Program," a financial risk-free manufacturing solution powered by the PanFlex® system. This program offers tailored production line construction services to global clients,which reduces the construction costs and timelines by 50%. This allows clients to postpone capital expenditure decisions from Phase I/II to Phase III of clinical trials,giving them more time to make informed investment choices. Additionally,the program provides a risk reduction feature: fees paid by clients are refundable regardless of whether the product succeeds in the market. This effectively offers additional insurance for commercialization and mitigates risks in the R&D and production phases.

Part III: BiBo Pharma 3.0: Shaping the Future - Establishing Comprehensive Technology Industry Advantages and Leading the Next Chapter

BiBo Pharma establishes an intensive production model,which underpins the company a diversified,full-technology platform offering one-stop CDMO services. With its Boston R&D center and global production capabilities,BiBo Pharma delivers high-quality services adhering to international standards. BiBo Pharma utilizes its unparalleled industry advantages to empower the global biopharmaceutical companies by reshaping the cost structure of biologics.

Additionally,the "Blue Whale Program" expands BiBo Pharma's established engineering solutions,reaching more clients with commercial production needs. Frost & Sullivan expects that these capabilities and advantages will position BiBo Pharma as the best solution for global pharmaceutical companies in the future.

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