In one engineering and technological miracle after another, Bibo Biotech has established itself as a disruptive position in the field of international biopharmaceutical manufacturing.

Bibo P03 factory (Shanghai, Lingang) is the place where the miracle of the world's biopharmaceutical manufacturing engineering was born: the largest single can in the field of biopharmaceutical manufacturing and the world's first ultra-large-scale production line stands here. Matching it is a factory building with a height of 24 meters and a total area of 65,000 square meters; there are more than 120 kilometers of process pipelines, 20 kilometers of clean room air ducts, nearly 500 kilometers of cables and wiring, 11 million parts, hundreds of sets/sets of core equipment, and each single line includes more than 5,000 key process nodes. For such a complex project, Bibo people completed the project delivery (Engineering Completion) in just 18 months. This is undoubtedly an engineering miracle in the world's biomedical field.

The realization of this miracle was accomplished under the guidance of Bibo's original and disruptive PanFlex®-Engineering system. The subversive nature of Bibo's PanFlex®-Engineering is directly reflected in the fact that it breaks the impossible triangle of "quality-time-cost" in the existing international biomedical engineering system and successfully achieves the engineering miracle of "higher quality-1/2 time-1/2 cost". The P03 project was completed with high quality in less than half the time of similar international projects, once again proving the disruptive significance of Bibo's PanFlex®-Engineering system; its influence will surely extend to the entire world's biopharmaceutical manufacturing projects. It can be called a classic case of world engineering projects and has important reference significance for the international engineering field.

After the delivery of the P03 project, Bibo aimed at another technological miracle to assert its position as a world leader in the fourth wave of biopharmaceutical manufacturing: achieving Right on the First Time and Success on the First time for customer project production on a brand-new 30,000-liter production platform.

To achieve the above goals, Bibo needs to face another impossible challenge: technically, a GMP production process that is extremely challenging on a 2,000-liter scale must be successfully scaled up to a 30,000-liter production platform at one time; engineering, this means In a complex system with more than 5,000 key engineering and process nodes, the fault tolerance rate of each node cannot exceed 3.4 parts per million (reliability needs to reach 99.99966%); and all of this must be achieved on a production platform that is put into use for the first time. What’s even more challenging is that the vast majority of Bibo’s front-line employees have no previous experience in large-scale production of more than 10,000 liters. The above-mentioned three extremely challenging factors of "engineering-technology-operation" are superimposed on each other, making "first-time hit, first-time success" an almost impossible task, which requires the Bibo team to face head-on with the spirit of Can-Do; and the world's largest first production line means that Bibo must explore areas that have never been touched before. Facing unprecedented challenges, Bibo people relied on their independent PanFlex®-Operation system, meticulous planning, sincere cooperation, and forge ahead. After more than 120 days of continuous struggle, they once again created a miracle: from the initial T-120 to From the meticulous planning of T-7, to the strict organization of production operations, and the coordinated operation of various departments, starting from the working cell bank (WCB), to the first, second, and third-level seeds, and even the 30,000-liter main reactor, the actual operation process perfectly matched the plan. On March 28, 2024, as the last drop of product was collected, Bibo people achieved a new 30,000-liter process scale-up production on a production platform that was put into operation for the first time. The technical miracle of "first hit, first success"! This technological miracle not only represents the official opening of a new chapter in Bibo's large-scale commercial production of biopharmaceuticals, but also indicates that Bibo's name has been added to the global CDMO large-scale production line club; what is even more predictable is that Bibo's unique ultra-large-scale production line will also have a profound impact on the world's biopharmaceutical production pattern.

The creation of these engineering and technical miracles is inseparable from the full cooperation and close cooperation of Bibo's Boston team and all Bibo employees including the Shanghai Project Management Department, R&D Department, Production Department, Quality Department and Engineering Department. During this process, our engineers and scientists have demonstrated extraordinary professionalism and problem-solving abilities. Their hard work and intellectual contribution are the key to this success. At the same time, the successful implementation of the PanFlex-Operation system represented by T-7 in this process once again proves the extraordinary performance of Bibo's original PanFlex comprehensive system, which is the basis for Bibo to achieve an internationally leading operation system.

After ten years of sharpening a sword, the creation of miracles again and again is undoubtedly the perfect interpretation of the Can-Do spirit of Bibo Biotech that dares to be the first in the world and dares to succeed; it is also the best confirmation of Bibo International's leading engineering and technical strength, operation management capabilities and innovative spirit. These successes mark another outstanding step taken by Bibo in its journey to the top of global biopharmaceutical manufacturing. It is these solid steps to create miracles that have led Bibo to gradually establish itself as a disruptor and leader in the field of international biopharmaceutical manufacturing, and thus continue to lead the fourth wave of global biopharmaceutical manufacturing, making Bibo a biopharmaceutical CDMO that cares about the people, has the willingness and ability to provide "high quality and low price, and guaranteed supply" to the people around the world.