Shanghai Bailun Biotechnology Co., Ltd.

Email：blbio369@163.com

Tel：021-67867376

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Biotechnology Development and Engineering

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Biotechnology Development and Engineering

Early consultation and process development services

Bailun provides full-cycle process development services for biopharmaceuticals, industrial enzymes and synthetic biology. With quality by design concept and experimental design methodology as the core, we build a predictable and scalable biomanufacturing system. Based on the physical and chemical properties of the target product and commercialization needs, we customize the development framework from expression system selection to production strategy design through systematic risk assessment and technical route planning, clarify the dynamic relationship between key quality attributes and process parameters, and avoid technical blind spots and intellectual property risks. In the cell line development stage, relying on high-throughput screening and gene editing technology, we optimize cell growth performance and product expression stability, and simultaneously develop culture media with clear chemical composition to balance product titer and quality consistency; in upstream process development, we integrate metabolic models and real-time monitoring technologies, accurately control culture conditions and establish scientific rules for cross-scale amplification to ensure process robustness and production adaptability; in the downstream purification stage, through chromatography strategy design and impurity removal model, we optimize product recovery efficiency and purity to meet regulatory compliance requirements. With data-driven as the core, we build digital twin models to achieve forward-looking prediction of process modes, embed production compliance assessment into the entire development process, and work with interdisciplinary technical teams to overcome the trial-and-error costs and cycle bottlenecks of traditional development. Through end-to-end services from feasibility analysis to technology transfer, Bailun helps customers anchor the industrialization path of scientific hypotheses and drive the overall improvement of biomanufacturing efficiency and value with systematic innovation.

05-28

2025

Facility and conceptual layout capability

With "compliance, flexibility, and digitalization" as its core concept, Bailun provides full-process facility planning services from conceptual design to factory implementation for the fields of biopharmaceuticals, advanced therapies, and synthetic biology, deeply integrating process requirements, regulatory frameworks, and operating cost constraints, and systematically optimizing the strategic value of biomanufacturing infrastructure. Based on the concept of quality by design, we deeply combine product characteristics with production processes, simulate clean area zoning strategies, personnel/logistics topology networks, and equipment layout logic, significantly reducing cross-contamination risks and construction costs; for high-risk scenarios such as cell therapy and viral vectors, we design negative pressure isolators and disposable systems to meet special specifications such as ATMP for gene therapy drugs. In order to cope with pipeline iterations and market demand fluctuations, we adopt a "plug-and-play" modular architecture to support rapid switching of multiple products on the same line and flexible expansion of production capacity, and reserve process upgrade interfaces to achieve seamless connection from samples to commercial production; build a digital operation and maintenance base to optimize energy consumption, equipment status monitoring, and production scheduling in real time, reducing downtime risks and operating costs. We help companies avoid heavy asset investment risks by identifying facility bottlenecks early and balancing short-term clinical supply with long-term commercial needs. At the same time, we integrate water circulation and waste heat recovery systems based on LEED certification standards to promote green and sustainable manufacturing. Bailun reshapes biomanufacturing infrastructure with cutting-edge engineering thinking, making plant layout and equipment logic a strategic carrier for corporate technology display and efficiency advantages - here, facilities are not only physical spaces for production, but also the core engine that drives biotechnology from laboratory to industrialization.

05-29

2025

feasibility study

Bailun provides systematic feasibility study services for biopharmaceuticals, industrial enzymes and synthetic biology. Through technology maturity assessment, full life cycle economic modeling and risk prediction three-dimensional model, we build scientific and verifiable industrialization paths for innovative projects. Based on the molecular characteristics and commercialization needs of the target product, we integrate process development experience and market insights, conduct multi-technology route comparison, analyze the accessibility of key quality attributes through data modeling, and simultaneously propose intellectual property avoidance strategies in combination with patent map recognition technology; in the economic dimension, we build a dynamic model covering equipment investment, operating costs and supply chain flexibility, quantify the break-even point under different production capacity scales, simulate the impact of scenarios such as domestic raw material substitution and multi-product co-production on investment return rate, and optimize resource allocation efficiency. In response to potential risks in technology development, production scale-up and regulatory compliance, we systematically output risk priority matrices and hierarchical response plans, and plan process redundancy plans and emergency plans in a forward-looking manner. Through interdisciplinary team collaboration (process engineers, intellectual property experts, supply chain consultants) and data models driven by industry databases, we break through the limitations of traditional empirical decision-making and achieve a strategic upgrade from fuzzy assumptions to quantitative deductions. Bailun identifies the industrialization path with the highest success rate at the beginning of the project, providing executable decision-making guidance for the transition from scientific exploration to commercial success.

05-29

2025

project plan

Bailun provides a full range of project planning services for the development of biopharmaceuticals, industrial enzymes and synthetic biology products, and builds a dynamic management and control system covering technology research and development, process development and industrial transformation. Based on the commercial milestone requirements of the target product, we customize the phased development path from concept verification to large-scale production, and clarify the dynamic mapping relationship between key quality attributes, process parameters and risk control nodes. Relying on experimental design tools, we decompose complex R&D tasks into quantifiable executable sub-modules, and simultaneously integrate resource input and time cost models to achieve transparency of cross-departmental collaboration processes and maximize resource utilization; in response to technical uncertainties, we formulate process redundancy plans and rapid response mechanisms, and ensure that the project does not deviate from the preset goals through milestone review meetings and phased delivery. Establish a full-process document control system from experimental records, data traceability to change management to shorten the technology transfer and audit preparation cycle. Through the AI-driven progress prediction system, dynamically adjust development priorities and resource allocation strategies to respond to market demand fluctuations or regulatory policy changes. Bailun reconstructs the development logic of biomanufacturing - from passive execution to active control, from linear advancement to closed-loop iteration, so that the technological breakthroughs at each stage can be accurately converted into reusable industrial capabilities, creating a high-confidence decision-making chain from laboratory to commercialization for innovators.

05-29

2025

Project Implementation

Bailun provides full-process engineering implementation solutions for the fields of biopharmaceuticals, cell therapy and synthetic biology. With the core concept of "agile delivery, green production, and intelligent management and control", it opens up the industrialization implementation path from process model to commercial production. Based on the core parameters and industrial transformation needs of the process development stage, we use multi-scale dynamic modeling and digital twin technology to build predictable process amplification rules, and combine adaptive control systems and modular production units to achieve precise amplification from laboratory to ton-level fermentation tanks, while reducing energy consumption and material loss. In the design and construction of factories, a low-carbon-oriented green engineering solution is adopted, which can integrate renewable energy power supply systems, closed-loop water circulation networks and waste resource processing modules to meet ESG standards and carbon footprint certification requirements; through intelligent warehousing logistics and edge computing equipment, an end-to-end digital factory is created to ensure that the entire production process meets data integrity and GMP compliance. Through the deep integration of green technology and intelligent systems, Bailun makes each factory a symbiosis of technological innovation and ecological benefits, providing the global bioeconomy with the next generation of infrastructure that combines productivity, sustainability and anti-fragility.

05-29

2025

Shanghai Bailun Biotechnology Co., Ltd.

Liu Xiang Road 6848， Hua Ting Town, Jiading District, Shanghai

Tel：+8615195778508

E-mail：blbio369@163.com

Products Center

Bioreactors and fermenters

Single-use equipment

In-line inspection system

Membrane filtration systems

High-pressure homogenizer

Centrifugation equipment

Drying equipment

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SEO

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