Over 50 Government Officials and Corporate Executives Register for Biomanufacturing Pilot-Scale Training—Why the Surge in Interest?

Pilot-scale platforms are a critical step in the field of biomanufacturing for translating laboratory research outcomes into industrial production. They simulate actual production environments to validate and optimize the feasibility of technologies for large-scale manufacturing.

Some refer to pilot-scale platform validation as the “Valley of Death” in biomanufacturing; only by crossing this “Valley of Death” can large-scale commercial production of products be achieved.

Recently, the Tianjin Institute of Industrial Biotechnology of the Chinese Academy of Sciences, Bloomage Biotech, Dr. Fang, and VCBeat jointly launched a training course titled “Ideas and Solutions for Building Pilot-Scale Platforms in Bio-Manufacturing in 2024.” Leveraging the mature expertise of institutions such as the Tianjin Institute of Industrial Biotechnology of the Chinese Academy of Sciences and Bloomage Biotech, the course aims to help bio-manufacturing enterprises effectively address critical pain points and challenges in a single, comprehensive solution.

Training Name: Training on the Concepts and Plans for Building a Pilot-Scale Platform for Bio-Manufacturing in 2024

Training Time: September 23–24, 2024 (tentative)

Training Venue: Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences

Training Scale: 60-80 attendees (limited venue capacity, first come, first served)

Organizer: Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences; Scientific Development and Advisory Professional Committee of the Chinese Society for Microbiology; Bloomage Biotechnology Corporation Limited

Organizer:Dr. Fang, Beijing Danhuang Technology Co., Ltd. (VCBeat)

It is reported that the training program will last a total of two days, comprising 1.5 days (10 hours) of theoretical study and 0.5 days (2 hours) for visits to pilot-scale platforms.The instructors are experts from the Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences, and the business head of Bloomage Biotech’s Pilot Scale-up Achievement Transformation Center. Combining systematic design thinking with hands-on practical experience, this training is suitable for professionals from institutions and enterprises that are planning, currently building, or have already established pilot-scale platforms.

Since the course materials were released, more than 50 government officials and corporate executives have registered for the event, generating significant interest.

Based on registration data, we found that approximately 53% of institutions are in the “preparing for construction” phase of building pilot-scale platforms for bio-manufacturing. This indicates abundant collaboration opportunities across the industry value chain, such as the supply of bioreactors, testing instruments and equipment, consumables, and bio-based materials, as well as technical services including product refining and purification. Participating in related events not only provides access to professional expertise but also facilitates connections with value chain partners and expands business opportunities. (Sponsorship opportunities are now open; please inquire via the link at the end of this article!)

Partial List of Registered Participants:

The key issues that participants aim to address include:

• Challenges in Scaling from Laboratory Bench-Scale to Industrial Production

• Hardware and Software Requirements for High-Throughput Fermentation Optimization

• Talent Requirements for the Intelligent Biomanufacturing Pilot-Scale Platform

• Service Mechanisms and Management Models for Biomanufacturing Pilot-Scale Platforms

In response, the training course syllabus has also been specifically designed.

Training Topic: Pilot-Scale Platform for Intelligent Biomanufacturing

Lecturer: Researcher Xia Jianye

Training Outline:

Background, Challenges, and Solutions for the Construction of the High-Throughput Fermentation Module in Pilot-Scale Platforms (Part I)

1. Revolutionary Advances Brought by Synthetic Biology Biofoundries and the Bottlenecks in Industrializing Their Outcomes

• The Paradigm Shift in Research Driven by Automated Equipment for High-Throughput Strain Construction

• The Vast Discrepancy Between Standards for High-Throughput Screening of Microbial Strains and Industrial Environments

• Problems and Challenges Caused by Insufficient Fermentation Optimization Throughput

2. High-throughput fermentation optimization is the key hardware system for resolving bottlenecks

• Research Progress and Development Trends at Home and Abroad

• Application of Mature, Commercialized Products

• Development and Existing Deficiencies of Domestic Related Equipment Technology

3. High-Throughput Fermentation Optimization: Key Software Technology for Addressing Bottlenecks

• High-Throughput Experimental Design Methods

• High-Throughput Process Data Analysis Methods

• Applications of Data Science and Artificial Intelligence

Background, Challenges, and Solutions for the Construction of the High-Throughput Fermentation Module of the Pilot-Scale Platform (Part II)

4. Digitalization and Intelligence in the Construction of Pilot-Scale Platforms for Biomanufacturing

• Intelligent Sensing Infrastructure for Biomanufacturing Processes

• Digital Twins and Intelligent Decision-Making in Biomanufacturing Processes

• Possible Pathways for the Intelligentization of Biomanufacturing Processes

5. Talent Requirements for the Construction of Pilot-Scale Platforms in Biomanufacturing

• Demand for Interdisciplinary Talent in Biomanufacturing Processes

• Cultivation of Interdisciplinary Talents in Biomanufacturing Processes

• The Critical Role of Technical Managers in Biomanufacturing Processes

6. Reflections on the Operational Mechanism of Pilot-Scale Platforms in Biomanufacturing

• Construction of Credible Public Technical Service Platforms

• The Mission and Responsibility of Public Technical Service Platforms

• Potential Operating Mechanisms for the Privatization of Pilot-Scale Platforms

Training Topic: Development Concepts and Solutions for a Bio-Manufacturing Application Platform Targeting the Food Sector

Instructor: Professor Xia Xiaole, Senior Engineer

Training Outline:

●1. Background and Challenges in Building a Development Platform for Biomanufacturing Applications in the Food Sector

1.1 Background of Biomanufacturing in the Food Sector

1.2 Significance of Platform Development: Driving the Transformation and Upgrading of the Food Industry

1.3 Challenges in Building Food Biomanufacturing Platforms

●2. Research and Innovation in Platform Technologies for the Development of Biomanufacturing Applications in the Food Sector

2.1 Process Innovations in Food Bio-Manufacturing Platforms

2.2 Nutritional Evaluation of Food Bio-manufacturing Platforms

2.3 Toxicological Studies on Food Bio-Manufacturing Platforms

2.4 Applications of Food Bio-manufacturing Platforms

●3. Intelligent Construction of Biomanufacturing Platforms in the Food Sector

3.1 Hardware Specifications and Configuration for Food Bio-Manufacturing

3.2 Talent Requirements for the Food Biomanufacturing Platform

3.3 Management and Strategic Planning of Food Bio-Manufacturing Platforms

●4. Summary and Outlook

4.1 The Role of Platforms in Driving Technological Innovation in the Food Industry

4.2 Outlook on the Long-Term Impact of Platforms on Sustainable Development in the Food Industry

Training Topic: Overall Approach to the Construction and Operation of Pilot-Scale Production Platforms

Lecturer: Researcher Sun Jibin

Training Outline:

1. Domestic and International Landscape and Development Trends of the Biomanufacturing Industry

2. The Importance of Pilot-Scale Platforms to National, Local, and Corporate Development

3. Positioning and Functions of the Biomanufacturing Pilot-Scale Platform: Process Optimization, Scale-Up Trials, Process Package Development, Application Development, Technology Transfer and Incubation

4. Construction Content and Overall Framework of the Biomanufacturing Pilot-Scale Platform, Including Pilot Fermentation, Downstream Processing, Industry R&D Laboratories, Analytical Testing Laboratories, and Utilities

5. Construction, Operation Models, and Sustainable Development of Pilot-Scale Platforms for Biomanufacturing, Including Funding, Talent, Projects, Management, Services, and Government-Enterprise Relations

Training Topic: Case Studies on Application Development of Bio-manufacturing Related Products

Lecturer: Rong Jinlei, Process Director, Pilot Scale-up and Technology Transfer Center, Bloomage Biotech

Training Outline:

●1. Conditions Required for Pilot-Scale Amplification

1.1 Process Stability and Product Stability

1.2 Operating Conditions, Raw and Auxiliary Materials, and Three Wastes Issues

1.3 Process Safety

●2. Common Issues in Pilot-Scale Scale-Up Processes

2.1 Device Compatibility and Tolerance

2.2 Performance Differences of Devices

2.3 Differences in Raw and Auxiliary Materials During Scale-Up

●3. Bloomage Biotech Pilot-Scale Case Study

3.1 Risks in the Pilot-Scale Amplification Process of BL-21 Series Strains

3.2 Process Control During the Scale-up of Escherichia coli

3.3 Process Optimization During Pilot-Scale Up

Training Topic: Construction, Operation, and Application of Bloomage Biotech's Pilot-Scale Platform

Lecturer:Wang Enxu, Assistant to the General Manager of the Pilot Scale-up and Technology Transfer Center at Bloomage Biotech

Training Outline:

●1. Significance and Positioning of Bloomage Biotech’s Pilot-Scale Platform Construction

1.1 Background & Significance of Pilot-Scale Platform Construction

1.2 Positioning of the Pilot-Scale Platform Development

●2. Characteristics and Capabilities of Bloomage Biotech’s Pilot-Scale Platform Construction

2.1 Characteristics of Pilot-Scale Platform Construction

2.2 Hardware Capabilities of the Pilot-Scale Platform

2.3 Software Infrastructure Capabilities of the Pilot-Scale Platform

●3. Service Model and Advantages of Bloomage Biotech’s Pilot-Scale Platform

3.1 Service Model of the Pilot-Scale Platform

3.2 Service Advantages of the Pilot-Scale Platform

3.3 Service Cases of the Pilot-Scale Platform

●4. Future Outlook

Training Topic: Conceptual Framework and Solutions for Building a Biomanufacturing Application Platform for Cosmetics-Grade and Pharmaceutical-Grade Products

Lecturer:Xue Guoxi, Process Director, Pilot Scale-up and Technology Transfer Center, Bloomage Biotech

Training Outline:

●1. Background and Challenges in Building a Development Platform for Biomanufacturing Applications in the Cosmetics and Pharmaceutical Fields

1.1 Background of Biomanufacturing in the Cosmetics and Pharmaceutical Fields

1.2 Significance of Platform Development: Promoting Transformation and Upgrading in the Pharmaceutical Industry

1.3 Challenges in Building Platforms for Cosmetics and Biopharmaceutical Manufacturing

●2. Intelligent Construction Strategies for Biomanufacturing Platforms in the Cosmetics and Pharmaceutical Sectors

2.1 Hardware Specifications and Configuration of the Pilot-Scale Platform

2.2 Pilot-Scale Platform: Architectural Configuration and Talent Requirements

2.3 Matching of Supporting Facilities

●3. Key Points in the Operation of Biomanufacturing Platforms in the Cosmetics and Pharmaceutical Fields

3.1 Quality System Level

3.2 Registration Level

3.3 Confidentiality Aspects

●4. Summary and Outlook

*More training outlines are continuously being updated

● Researcher Xia Jianye, Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences

Xia Jianye, Research Fellow and Doctoral Supervisor, is a recipient of the Chinese Academy of Sciences (CAS) “Hundred Talents Program” and a Leading Talent in Tianjin. He serves as Vice Chairman of the Special Committee on Biochemical Process Modeling and Control under the Chinese Society for Microbiology, and currently holds the position of Director of the Intelligent Biomanufacturing Pilot Platform at the Tianjin Institute of Industrial Biotechnology, CAS.Dr. Xia received his Ph.D. from East China University of Science and Technology in 2008, studying under Professor Zhang Siliang. He proposed an optimization and scale-up methodology for fermentation processes that integrates reactor flow field dynamics with cellular physiology, which has been successfully applied in numerous biomanufacturing enterprises across China. His accolades include one Second Prize of the National Science and Technology Progress Award, one First Prize of the Shanghai Science and Technology Progress Award, and one Second Prize of the Science and Technology Progress Award from the China National Light Industry Council. He has published more than 30 research papers in prestigious journals such as *Cell*, *Nature Communications*, *Biotechnology and Bioengineering*, and *Trends in Biotechnology*, and holds five authorized patents.In July 2021, Dr. Xia joined the Tianjin Institute of Industrial Biotechnology, CAS, as a full-time researcher. He was responsible for establishing the laboratory platform of the Intelligent Biomanufacturing Center and built a 6,000-square-meter digitalized and intelligent biomanufacturing pilot platform. By innovating the technical service mechanisms of the pilot platform, he facilitated the industrial translation of three synthetic biology products from the laboratory to commercial production.

● Researcher Sun Jibin, Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences

Aug. 2020–Present, Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences, Director of the Center for Systems Biology

Research Areas: Systems biology of industrial microorganisms; multi-omics technologies; synthetic biology technologies; design and development of industrial strains

● Shao-Ping Fu, Senior Engineer (Professorial Level), Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences

Shao-Ping Fu, male, born in 1978, holds a Ph.D. and is a Senior Member of the Chinese Chemical Society. He serves as a Senior Engineer at the Center for Intelligent Bio-manufacturing, Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences (CAS). He received his Ph.D. in Analytical Chemistry from the Dalian Institute of Chemical Physics, Chinese Academy of Sciences, in March 2006. In the same year, he joined the School of Biological and Food Engineering at Dalian Polytechnic University. From 2008 to 2009, he conducted research on the separation and structural identification of complex components of plant natural products at the Universidad de Granada in Spain. In October 2012, he joined the Tianjin Institute of Industrial Biotechnology, CAS, where his primary research focus has been on the separation and purification processes for bio-fermentation products. He has presided over key projects under the Tianjin Municipal Science and Technology Support Program and the National Key R&D Program of China. He was responsible for completing the development of separation and purification processes for more than thirty industrialization projects involving lycopene, inositol, protocatechuic acid, and other compounds, generating significant economic value. His accolades include the Second Prize for Scientific and Technological Progress of Dalian City (2010), the Second Prize for Scientific and Technological Progress of Liaoning Province (2011), selection as one of the “High-Level Talents Introduced to Tianjin (Over 1,000 Individuals in Three Years)” (2012), selection as a Tier II candidate in the Tianjin Binhai New Area “131” Talent Training Project (2013), recognition as a “Key Technical Talent of the Chinese Academy of Sciences” (2019), and appointment to the “Distinguished Research Backbone Position” of the Chinese Academy of Sciences (2022).

● Professor Xia Xiaole, Academic Dean of the College of Food Science and Engineering at Tianjin University of Science and Technology, and Professor at the School of Biotechnology, Jiangnan University

Primary Research Areas:

1. Future Fermented Foods

Based on evolutionary analysis, synthetic biology and computational biology approaches are employed to identify, analyze interactions, and reconstruct the core microbiota of traditional fermented foods, with the aim of addressing issues such as food safety and flavor enhancement in industrial practice.

2. Synthetic Bio-manufacturing of Active Macromolecules

Health-RelatedActivityMacromolecules, such as lipopeptides, hydrolases, and Monacolin K, leverage computational biology and synthetic biology to address challenges in their synthesis, expression, and engineering, with applications in the life and health sectors.

● Rong Jinlei, Process Director at the Pilot Scale-up and Technology Transfer Center of Bloomage Biotech

Rong Jinlei, Master’s Degree Holder, currently serves as the Process Director at the Pilot Scale Achievement Transformation Center of Bloomage Biotechnology (Tianjin) Co., Ltd. With nearly two decades of professional experience in the development and optimization of microbial fermentation, extraction, and purification processes, he has accumulated extensive expertise in project development and scale-up for active pharmaceutical ingredients (APIs) of small-molecule bioactives, antibiotics, peptides, proteins, and macromolecular polysaccharides. He has achieved outstanding results in industrial fermentation media optimization, fermentation process improvement, and separation and purification optimization. Multiple products led by him have reached industry-leading levels in both cost efficiency and quality. As a key member, he participated in the key technology and industrialization project for glutathione (GSH) API and formulations, which was awarded the First Prize for Provincial Scientific and Technological Progress.

● Wang Enxu, Assistant to the General Manager of the Pilot Scale Achievement Transformation Center at Bloomage Biotech

Wang Enxu, Ph.D. candidate, Senior Engineer (Associate Professor level), and part-time Master’s supervisor at Tianjin University of Science and Technology, currently serves as Assistant General Manager of the Pilot Scale-up and Technology Transfer Center at Bloomage Biotech (Tianjin) Co., Ltd. He possesses comprehensive expertise in end-to-end synthetic biology technologies, with a holistic understanding of process development, scale-up, optimization, and commercial manufacturing of microbial fermentation products. With extensive experience in process development and industrial translation, he is dedicated to providing tailored bioprocessing solutions for clients. To date, he has built an elite team of 150 professionals and established deep collaborations with numerous renowned universities and research institutions, successfully completing pilot scale-up and industrial translation for more than 20 bioactive substances. Furthermore, he has participated in or led multiple large-scale projects, including the construction of a pilot scale-up and technology transfer center with a total investment exceeding RMB 1 billion and covering an area of 30,000 square meters. This project integrates advanced flexible production line designs, capable of simultaneously supporting pilot experiments and small-scale commercial production for six major categories of substances: functional sugars, proteins, peptides, amino acids, nucleotides, and natural active compounds, thereby laying a solid foundation for the company’s future industrialization strategy.

● Xue Guoxi, Process Director of the Pilot Scale Achievement Transformation Center at Bloomage Biotech

Xue Guoxi, Master’s Degree HolderWith 16 years of experience in pharmaceutical R&D at large pharmaceutical companies, Mr. Xue currently serves as the Process Director at the Pilot Scale Achievement Transformation Center of Bloomage Biotechnology (Tianjin) Co., Ltd. He has led and completed one project under the National Science and Technology Support Program (with funding of RMB 100 million), one major science and technology special project of Shandong Province (RMB 15 million), and one scientific and technological plan project funded by the Huayanghe City Finance Bureau (RMB 1.5 million). He holds four authorized patents. He has spearheaded the R&D and scale-up of 16 raw materials for pharmaceutical, food, and cosmetic grades, among which three products generate approximately RMB 500 million in annual profit for the company. He has completed regulatory filing for drug registration for six microbial fermentation projects, undergoing two FDA inspections and six GMP compliance inspections. He was responsible for the design and construction of fermentation and purification workshops with a fermentation capacity of 500 tons, and has successively established and operated six R&D and pilot-scale platforms.

*More instructor profiles are being continuously updated

The Intelligent Bio-Manufacturing Center is one of the six platform laboratories established under the National Center for Technological Innovation in Synthetic Biology. It serves as a pilot-scale bio-manufacturing platform that provides technical services and conducts key R&D activities essential for the industrialization of synthetic biology innovations, including strain performance validation, pilot process development and verification, trial production of samples ranging from kilograms to hundreds of kilograms, and scale-up of bio-manufacturing processes.Officially approved and established in September 2021, the Center has invested RMB 130 million in equipment and infrastructure, constructing 6,000 square meters of new laboratory space. Its facilities encompass a full chain of equipment for bio-process development, optimization, and scale-up, including high-throughput strain performance validation, high-throughput media optimization, high-throughput fermentation process optimization, and digitalized, intelligent pilot production lines.Focusing on intelligent manufacturing technologies for industrial biological processes, the Center develops key technologies such as strain validation, media optimization, process scale-up, and intelligent bio-manufacturing process packages. It drives the technological upgrade of traditional fermentation industries toward automation and intelligence, comprehensively supporting the efficient industrial translation of synthetic biology achievements. By significantly reducing the time and cost associated with transferring high-performance strains from laboratory development to industrial production, the Center provides intelligent manufacturing process packages ready for industrial-scale production.Since its establishment, the Center has actively explored new technical service models. It has introduced a novel pilot-scale service mechanism focused on ensuring the safety of core strains and innovatively proposed three customized and personalized service models: “Shared Kitchen,” “Shared Chef,” and “Contract Development.” To date, it has served more than 20 domestic bio-manufacturing enterprises, successfully facilitating the transition of three bio-manufacturing products from laboratory research to industrial production, achieving remarkable results.

Bloomage Biotechnology (688363.SH), established in 2000, is a globally renowned biotechnology and biomaterials company. Driven by synthetic biology technologies, the company is committed to continuously improving quality of life and extending lifespan, delivering healthy, beautiful, and joyful life experiences to humanity. Upholding its corporate mission of “Keeping Every Life Vibrant,” the company primarily focuses on the development and industrial application of bioactive substances that contribute to human health, including functional sugars, proteins, peptides, amino acids, nucleotides, and natural active compounds. As the world’s largest enterprise engaged in the research and development, production, and sales of hyaluronic acid, Bloomage Biotechnology ranks first globally in the industrialization of hyaluronic acid.

Ph.D. in Economics from Zhejiang University; Original Author of the WeChat Official Account “Dr. Fang”

Managing Director at Titanium Capital, overseeing government and corporate ecosystem partnerships, with a focus on synthetic biology, healthcare, and industrial internet.

During my tenure at the High-Tech Division of the Xiamen Municipal Development and Reform Commission, I was responsible for “mass entrepreneurship and innovation” initiatives, including the planning of startup parks, the drafting and promotion of entrepreneurial policies, and the implementation of policies for high-level talent. Previously, I served in the Strategy Division of the Xiamen Development Research Center, where I led research projects on the Belt and Road Initiative and regional economic trends. I also contributed to the editing of internal reference reports at the Zhejiang Provincial Policy Research Institute, with more than ten reports receiving written instructions from senior leaders, including the then Party Secretary of Zhejiang Province.

He also serves as a Distinguished Researcher at the Industry Research Center of Fudan University Zhangjiang Institute, a Member of the Expert Advisory Committee at the Xiamen Guoxin Credit Big Data Innovation Research Institute, and a Consultant for multiple startup enterprises.

Technology projects involving investment, financing, or advisory services have secured over RMB 10 billion in funding, including Anchnet, HEC Pharm, Crown Bioscience, Lifetech Pharmaceutical, Yunyin Technology, and U-Loveit.

Areas of Expertise: Regional development planning, policy consultation and project applications, business plan writing, coaching for startup roadshows, restructuring of corporate operations and finances, and facilitation of investment and financing matchmaking.

VCBeatFounded in 2014, it is a company that leverages data as its foundation, research as its core, and brand media as its connector to facilitate the precise aggregation of industrial resources and help industry changemakers achieve rapid growth.Innovative Industry Service Agency. Egg Yolk Tech focuses on the life and health sector, providing services such as brand communication, research consulting, data monitoring, and resource/project matchmaking to enterprises, scientists, government industrial parks, investment institutions, and other entities within the industry chain. Since its establishment, Egg Yolk Tech has secured investments from multiple renowned firms, including Legend Capital, BV Baidu Ventures, Honghui Capital, Changling Capital, Yifang Group, and Weilai Capital, achieving a valuation of several hundred million RMB. Under the Egg Yolk Tech umbrellaVCBeat, innovation and investment in China's healthcare and medical industryOne of the well-known media outlets.