Great Bay Bio Announces Official Launch of Its First AI-enabled Bioprocessing Platform, Klone 4.0, Reducing Cell Line Development Time and Cost by Up to 80%

Created on:2020-10-15 14:27

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October 15th,2020 Press Release

 

Great Bay Bio Announces Official Launch of Its  First AI-enabled Bioprocessing Platform, Klone 4.0,  Reducing Cell Line Development Time and Cost by Up to 80%

 

[2020/10/15, Dongguan] On October 15th, 2020, Great Bay Bio (abbrev. GBB) announced the official commercial launch of its self-developed, AI-enabled Klone 4.0 cell line development platform. Per Michael Chen, CEO, "We are very pleased with the successful outcomes of our proof of concept development trials both in-house and with our new customers who had already elected to come on board. We are seeing firsthand how this platform pioneers to deeply integrate our proprietary AI methods with our cell line development techniques to achieve an efficient and high-quality output and believe this can be provided to almost any developer of biological drugs. Our image-based, deep machine-learning process has taken cell line development off the beaten track to solve many of the industry's pain points at this stage of bioprocessing, and we believe this application of AI will continue to drive the biopharma industry into its new era of AI-enabled drug development technologies. We are proud to be one of the new leaders in AI-led innovation for our industry."

 

About Klone 4.0

 

In the world of biological drug development, once a certain protein or antibody is determined to show therapeutic value, the next step is to transfect that molecule to a cell pool and begin the process of cell line development. This is the fundamental beginning of bioprocessing for any new biologic and is, of course, an essential step to bringing these promising cures to the clinic. The industry focus for bioprocessing in recent years has been on faster completion times and higher expressing yields with many dollars spent to achieve this. Now Klone 4.0 accomplishes both in a manner that could potentially disrupt the bioprocessing industry, firstly by reducing development times by up to 80% as AI eliminates many of the laboratory pain points through GBB's proprietary deep machine learning techniques and algorithms and then by locating those cells with the highest expression capability in record time, in fact, approximately four hours. 

Ⅰ: Klone 4.0 Emerges in the Midst of the AI-Revolution in Healthcare Technology

 

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

 

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 not an easy 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 faster and simpler way has become a must-have for biopharmaceutical developers, and in recent years this has been indicated by increased investment in new technologies, more outsourcing, and greater complexity. We believe the deep machine learning advantages of GBB's Klone 4.0 now offers a simpler, faster, and lower-cost solution.

 

When it comes to solving the difficulties in cell line development, methods have varied from period to period. According to ICH guidelines, cell lines for production must be derived from an established and documented single cell. Commonly used single-cell cloning methods include the limited dilution method, flow cytometry single-cell spreading plates, ClonePix™, and the Beacon® Optofluidic System. These methods are not without limitation and are not without a significant cost in terms of time or dollars invested. In 2019 Great Bay Bio turned its attention and resources to AI as an alternative lower-cost solution in sharp contrast to the growing industry trend toward investment in expensive capital equipment.

 

Since AI can perform rapid calculations for large amounts of data, it has shown advantages in many fields. Late in 2018 Kingsley Leung, Chairman of Great Bay Bio, a sophisticated leader in biopharmaceutical development in Hong Kong, sensed that the characteristics of AI dovetailed the needs of cell line development. Together with his newly-recruited CEO, Michael Chen, Ph.D., a successful CMC veteran with 30 years in life science in the US, brought in the necessary resources to make AI-enabled cell line development a reality at Great Bay Bio. Hence, within one year, by the end of 2019, Klone 4.0, a platform that applies AI to cell line development, was born. In 2019 two teams were formed. First was GBB's own CMC bio team, experienced in all the traditional techniques for cell line development in their award-winning, state-of-the-art facility. This team of laboratory professionals understood well the pain points involved with cell line development and were then joined by a newly recruited 8-person AI development team who in a matter of months solved them. The result was surprising. In record time, by merging AI with traditional CMC techniques, monoclonality was achieved in four hours. The normal lab time for this step? Ten weeks. Then, a completed cell line using a commercially available cell pool was also completed in record time, six weeks compared to a normal development time of six to eight months. Any other surprises? Yes, a burst in expression levels like these scientists had never seen, a clear side-benefit to Big Data, rapid AI cell morphology identification, and now, much larger machine-readable cell sample quantities. It was an AI recipe for success in a niche application, but a very important one, cell line development. In 2020, again under Dr. Chen's leadership, Klone 4.0 was then tested, proven, and made commercially available, leading to its official launch in October 2020.

 

Ⅱ: What Defines GBB's K4 Platform? 

 

A good cell line requires high protein expression levels in cells that are highly stable, and only a good cell line development platform can achieve them. These and other key factors combine to determine the success of a cell line development platform, i.e., efficient generation of multiple high-yield cell lines for evaluation, early recognition of viable drug 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 the intelligent application of cell line construction.

 

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

 

 

An old buzzword in exploratory science and diagnostics goes like this, "have the picture, have the truth." A new buzzword prevailing in the medical industry is, "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 departments of pathology, radiology, dermatology, oncology, and others that produce and use a large number of images are now themselves in a digital revolution. GBB's Klone 4.0 platform has applied this same imaging technology to the development of cell lines, screening, and categorizing hundreds of thousands of cell images at one time.

 

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

 

 

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 also uses deep machine 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 error, the Klone4.0 platform utilizes a self-developed, robotic, single-cell selection machine to automatically select high-yield monoclones in a four-hour timeframe, providing customer feedback on Day 1.

 

Ⅲ: Klone 4.0: a New Cost-effective Bellwether in the Bioprocessing Industry; Pointing the Way Forward

 

For a long time, market pain points such as "high investment", "high risk", and "long development time" have been a drag on preclinical biological drug 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 traditional drug development and reduces a ton of repetitive labor, but also greatly improves the success rate of screening. Furthermore, its commercial package comes with competitive edges like "fast, high yield, zero-risk", among others, while it ushers the development of cell lines into the era of industrial informatization 4.0.

 

Values of Klone 4.0

 

1. Higher Expression: Deep machine learning and AI intelligent prediction make it easier to find cells with high expression.

 

2. Up to 12 Based upon September 2020 customer proof-of-concept data. Twenty-five (25) higher-yielding cell lines were derived using Klone 4.0 as compared to two (2) from a traditional cell line development method from the same cell pool. Results may vary.
More Cell Line Candidates: This goes beyond industry standards, providing customers with more options and more possibilities.

 

3. Stability Prediction: In the industry, we have pioneered to utilize deep machine 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 for GBB, and GBB hopes to set a new industry standard and perhaps a new milestone in medicine by – bringing cures to the market faster while lowering patient costs.

 

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

 

During its "soft marketing" period, the Klone4.0 platform has been applied in the market before its official launch, and we are in cooperation with more than ten biopharma companies at home and abroad to develop cell lines. At present, we have successfully delivered two cell lines requested by our customers, and the rest are in the process of either scheduling or preparing cell pools for their target cell lines. Our customer list is a demonstration of their trust and willingness to move to AI-enabled technology for CMC drug development.

 

Although the landscape is rapidly changing,biomedical R&D communities have been slower to embrace AI compared to other industries, particularly in the CMC preclinical phase. This is largely due to the novelty of the application and the limited number of AI experts in the industry. Dr. Michael Chen points out that, "The combination of artificial intelligence and biomedicine echoes the call of the time we are all in, and this is exactly where we at GBB should invest our efforts. I believe AI is bringing our industry into a bright future, removing pain points in development, speeding drug delivery, and lowering drug costs across the board. In this fertile land of AI, we expect to develop more platforms such as Klone 4.0 to burst into bloom and bear fruit. This is the value we see, and after a great start our choice is to continue to lead this effort in our area of the playing field."

 

About Great Bay Bio

Headquartered in Hong Kong, GBB is a high-tech enterprise dedicated to applying artificial intelligence and other cutting-edge technologies to CMC (Chemistry, Manufacturing, Control) for development of biopharmaceuticals and other blue ocean bio-products (such as cell therapy), ultimately solving numerous pain points of CMC development, including high failure rates, long development timeline and high costs. Since the company’s establishment, it has obtained massive data from conventional biologics development in its 3100 m2 CMC facilities in Dongguan, PRC. With over RMB 300M investment, the facilities bolster advance equipment from world-renowned manufacturers. GBB has also successfully brought a number of biologic products to NDA stage, some of which are classified as national class I innovative drugs. Currently, the company has created the intelligent centralized database, where deep learning is being performed to create next generation AI-enabled CMC platforms. To learn more, please visit http://www.greatbay-bio.com.

 

PR Contact: Miss Liu 

Email: yt.liu@greatbay-bio.co

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