Bravo! Klone 4.0 is coming!

Created on:2020-10-15 09:59


October 15th,2020 Press Release

Bravo! Klone 4.0 is coming!


[2020/10/15, Dongguan] Cell line development is the fundamental start of bioprocessing. Pharmaceutical companies around the world boast their own ways and experience of cell line development, while a large amount of labor, material resources as well as costs are needed. Therefore, they are struggling to shackle the tackles in traditional drug development process, namely “high investment, high risk and long period”. Over the years we have seen the extensive application of AI technologies in multiple industries. With AI empowering cell line development, new synergies along the way will be created.


On October 15th, 2020, the Great Bay Bio self-developed AI-enabled Klone 4.0 platform is officially launched. This platform pioneers to deeply integrate cell line development and the AI technology, realizing an efficient and quality output and getting off the beaten track to solve the market pain points. It might drive the industry into a new era!


Ⅰ: Klone 4.0 Platform Emerges in the Revolutionary AI Technology


A good cell line has exact demands for key metrics such as yield (fixed investment and single production cost), quality (efficacy and safety), stability, compatibility (mass production scale-up), compliance (monoclonality and complete experimental documentation of the entire process), etc.


Engels said, “When society has a technological need, it can push science forward more than ten universities can.”. The principle of cell line development is not complicated, i.e., transfecting plasmids into the cell and then incorporating them into the host cell's genome,but constructing a cell line suitable for industrial application is no mean feat. In fact, the probability of obtaining high -yield, high quality cell lines is extremely low, and the process of obtaining them is time-consuming and laborious. Therefore,how to obtain high quality cell lines in a more simple way has become a must-have for biopharmaceutical developers.


When it comes to solving the difficulties in cell line development, methods varied from periods to periods. According to ICH guidelines, cell lines for production must be derived from a single cell. Commonly used single-cell cloning methods including the limited dilution method, flow cytometry single-cell spreading plates, ClonePix, and the expensive Beacon® Optofluidic System.


Since 2017, international pharmaceutical giants began to deploy AI-based R&D strategies to improve the efficiency of new drug development, such as Merck, Novatis, Roche, Pfizer, and Johnson & Johnsone. Based on its AI-empowered patient monitoring system, AbbVie's can better understand its current Phase Ⅱ study in schizophrenia patients, thus increasing its data insights and reducing clinical trials. Furthermore, it also capitalizes on AI to optimize its manufacturing process; AstraZeneca uses AI and machine learning to develop new therapies for chronic kidney disease and idiopathic pulmonary fibrosis to accelerate drug innovation, thereby tracking the nature of diseases such as Parkinson's disease.

Since AI can perform rapid calculations for large amounts of data, it has shown advantages in many fields. Kingsley Leung, Chairman of Great Bay Bio, a sophisticated leader in biopharmaceutical development, sensed that the characteristics of AI dovetail the needs of cell line development. Hence, Klone 4.0, a platform that applies AI to cell line development, was born.


Ⅱ: What Defines K4 Platform is nothing but its Capability of Obtaining Monoclones in just 4 Hours

A good cell line requires highly, and so does a good cell line development platform. Many key factors combined to determine the success of a cell line development platform, including high yield (efficient generation of high-yield cell lines), candidates (rapid access to sufficient amounts of recombinant proteins for manufacturing feasibility studies and in vitro assays), stability, development cycle (speeding up the clinical launch of drugs), and workload (reducing human costs and human error) .

Klone4.0 boasts a cell line development platform developed by Great Bay Bio, which is able to screen hundreds of thousands of cells at a time, obtain cell images, and quickly analyze, locate, and select high-yield cells through AI and precise cell selection technology. Moreover, it is also capable of obtaining high-yield and high-quality cell lines within just four hours, which enables intelligent application of cell line construction.


Automated Imaging Technology: Rapid Acquisition of Cell-Based Attribute Data

A buzzword has it that have the picture, have the truth. There is also a word prevailing in the medical industry, “have the picture, have the AI.” In recent years, all kinds of images such as X-ray, ultrasound, CT, NMR, etc. can be used for clinical judgment through artificial intelligence. In the department of pathology, radiology, dermatology, oncology and other departments that produce and use a large number of images have put “robot” on the agenda. Klone 4.0 platform has applied this technology to the development of cell lines, screening hundreds of thousands of cell images at one time.


Digital Localization Technology: Rapid Analysis of Cell Data, Precise positioning of High-yield Cells

What erects at the forefront of machine learning is deep learning, which uses complex hierarchical artificial neural networks. Deep learning is ideally suited for drug discovery because of its unprecedented ability to extract key features from raw unprocessed data or data sets. The Klone 4.0 platform uses machine deep learning to make precise targeting of high-yield cells a reality.


Precise Selection: Ensuring Cell Monoclonality

To shorten the cell line development cycle and reduce labor costs and human errors, the Klone4.0 platform utilizes a self-developed single cell selection machine to automatically select high-yield monoclones.


Ⅲ: Klone 4.0: A new Cost-effective bellwether in Cell Line Industry, Pointing the Way Forward


For a long time, market pain points as “high investment”, “high risk”, and “long lifecycle” are like desert tundra dragging the experimental field of pharmaceutical development. Fortunately, AI provides a new fertile ground for biopharmaceuticals with its high efficiency, intelligence and precision. Klone 4.0 not only gets off the beaten track of the traditional drug development and reduces piles of repetitive labors, but also greatly improves the success rate of screening. Furthermore, it is embedded with edges like “fast, high yield, zero-risk”, among others, ushering the development of cell lines into the era of industrial informatization 4.0.


Values of Klone 4.0


1. Higher Expression

Machine deep learning and AI intelligent prediction make it easier to find cells with high expression.


2. 3-5 times more Cell Line Candidates

This goes beyond industry standards, providing customers with more options and more possibilities.


3. Stability Prediction

In the industry, we pioneer to utilize machine deep learning to predict cell line stability in a short time.


4. Simple and Cost-effective Process

With “time and cost saving” written into its DNA, AI delivered extraordinary fruits in cell line development. And it boasts the potential to set a new milestone for mankind -- lowering the price of drugs. The natural advantage of AI's "time-saving" capabilities is that the results of its application in cell line development are equally surprising, and has the potential to reinvent the milestone for humanity - lowering drug prices.


Ⅳ: Recognized by Domestic and Overseas Markets, Klone4.0 Has a Broad Application Prospect


During the “soft marketing”, Klone4.0 platform has been applied in the market before its official launch, and we have cooperated with more than ten pharmaceutical companies at home and abroad to develop cell lines At present, we have successfully delivered two cell lines required by our customers, and the rest are in the process of smoothly completing the target cell lines required by our customers with high efficiency, which has won their trust and recognition.


Biomedical R&D communities tend to be slower to embrace AI because of the preciseness of experts in this industry. Dr. Michael Chen pointed that, "The combination of artificial intelligence and biomedicine echoes the call the time, and this is exactly where we should invest our efforts. I believe it be will be shining brightly in near future. In this fertile land of AI, we expect more platforms such as Klone 4.0 to burst into bloom and bear fruits.


About Great Bay Bio 

Headquartered in Hong Kong, Great Bay Bio is a high-tech enterprise dedicated to developing biotechnological and biopharmaceutical products based on AI technology. Currently, Great Bay Bio owns several subsidiaries, including Hong Kong Great Bay Biotech Co., Ltd., Dongguan Taili Biotech Co., Ltd., and Guangzhou Taili Biomedical Technology Co., Ltd. We have invested more than RMB 300 million in R&D equipment and successfully established an independent and integrated technology platform for drug development and large-scale preparation.


The platform has been successively recognized as “Patent Fostering Enterprise”, “Patent Pilot Enterprise”, “National High-tech Enterprise”, “Dongguan City New Type R&D”, and “Top Ten Foreign-funded R&D Center of Guangdong Province”, “Guangdong Gene Engineering and Pharmaceutical Engineering Research Center, Guangdong Doctoral Workstation. Since 2006, we have undertaken a number of government projects and received funding from several provincial and national governments, including the “Guangdong-Hong Kong Key Breakthrough Project in Key Areas” and the “National Major New Drug Discovery Project”.



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