Nebulabio is a globally integrated Contract Development and Manufacturing Organization (CDMO) providing a unique Industrial-Scale Customization Platform. Our mission is to be the catalyst for innovation, transforming pioneering scientific concepts into commercially viable, high-volume biological products. We move beyond standardized production to offer a truly collaborative and flexible partnership, designing and executing bespoke manufacturing solutions tailored to your molecule's specific needs and market ambitions. With state-of-the-art facilities spanning multiple continents and a deep bench of experts in process sciences, engineering, and regulatory affairs, we provide an end-to-end service from cell line and process development through to commercial-scale cGMP manufacturing and fill-finish. We are dedicated to accelerating your timeline, derisking your scale-up, and ensuring a reliable, cost-effective supply chain for your most critical biologics, vaccines, enzymes, and novel therapeutic modalities.
☞Introduction to the Industrial-Scale Customization Platform
Nebulabio’s Industrial-Scale Customization Platform represents a paradigm shift in biomanufacturing, combining the flexibility and innovation of a development partner with the capacity, rigor, and reliability of a global manufacturing leader. This platform is built on several core pillars:
①Tailored Solution Design: We reject a "one-size-fits-all" approach. Every project initiates with a deep technical dialogue to understand your molecule's characteristics, target profile, and commercial goals. We then design a fit-for-purpose strategy, selecting the optimal host system (microbial, yeast, mammalian, novel systems), expression platform, and purification train.
②Modular and Scalable Infrastructure: Our facilities feature modular production suites and a fleet of bioreactors ranging from pilot (50L - 500L) to large industrial scale (2,000L - 15,000L). This modularity allows us to perfectly match capacity to your product's lifecycle stage—from clinical supply to blockbuster commercial demand—enabling seamless, tech-transfer-free scale-up.
③Integrated End-to-End Services: We offer a fully integrated "concept-to-commercial" pathway under one roof. This includes:
● Strain/Cell Line Development & Banking
● Process Development, Intensification, & Characterization
● cGMP Drug Substance Manufacturing (Upstream & Downstream)
● Analytical Development, Quality Control (QC), and Stability Studies
● Formulation Development, Drug Product Fill/Finish (vials, syringes, cartridges), and Lyophilization
● Comprehensive Regulatory Support & Documentation
④Technology Agnosticism & Innovation: We maintain expertise across a broad technology spectrum—from classic CHO and E. coli platforms to advanced continuous processing, single-use bioreactor trains, and novel expression systems. We leverage data analytics and process modeling (QbD/PAT) to drive efficient development and robust control.
| ☎ +86-15801534258 | ✉ info@nebulabio.cn | Contact Us ☜☜ |
☞Applications of the Industrial-Scale Customization Platform
Our platform serves as the industrial engine for a diverse range of high-value bioproducts:
● Commercial Biologics Manufacturing: Large-scale, ongoing production of monoclonal antibodies, fusion proteins, bispecifics, and other therapeutic proteins for marketed products, including biosimilars and lifecycle management.
● Vaccine Manufacturing: Full-scale production of recombinant protein antigens, virus-like particles (VLPs), and viral vector-based vaccines, supporting global immunization programs.
● Industrial & Specialty Enzymes: Cost-effective, mega-scale fermentation and purification of enzymes for biofuels, agriculture, food & beverage, textiles, and molecular biology research reagents.
● Advanced Therapeutic Modalities: Dedicated development and scalable manufacturing solutions for complex modalities such as antibody-drug conjugates (ADCs), gene therapy vectors (AAV, Lentivirus), and engineered cell therapy components.
● Diagnostic & Life Science Reagents: High-volume production of critical raw materials, including purified antigens, antibodies, and proteins for diagnostic kits, assay platforms, and research use.
☞Large Scale Industrial Production Service Process
Our industrial production process is a gated, phase-appropriate journey designed for quality, consistency, and regulatory compliance.
①Process Lock & Tech Transfer: The client-transferred or internally developed process is locked, scaled, and meticulously transferred to the commercial manufacturing suite. This includes facility fit assessment, equipment qualification (IQ/OQ), and procedure drafting. ②GMP Material Readiness: A cGMP Master/Working Cell Bank is thawed and released. All raw materials, buffers, and consumables are qualified and released according to GMP standards. ③Upstream Industrial Fermentation/Cell Culture: ● Inoculum Expansion: A multi-step seed train in shake flasks and seed bioreactors generates the production-scale inoculum. ● Production Bioreactor: The inoculum is transferred to a large-scale stainless-steel or single-use production bioreactor. A precisely controlled fed-batch or perfusion process runs for days to weeks, with continuous monitoring of critical parameters (pH, DO, temperature, metabolites). ④Harvest & Primary Recovery: The culture is harvested. For intracellular products, cells are disrupted via homogenization. Clarification using industrial-scale disk-stack centrifuges and depth filters yields a clarified harvest. ⑤Downstream Purification at Scale: ● Capture: The harvest is processed through large-diameter chromatography columns (e.g., Protein A, affinity) in batch or continuous mode. ● Viral Clearance: For mammalian products, dedicated low-pH hold, solvent/detergent, and/or nanofiltration (viral filter) steps are executed. ● Polishing: Sequential chromatography steps (IEX, HIC, Mixed-Mode) on large-scale columns remove impurities. ● Ultrafiltration/Diafiltration (UF/DF): Using industrial-scale TFF skids, the product is concentrated and diafiltered into the final formulation buffer. ⑥Drug Product (DP) Processing: The purified drug substance undergoes sterile filtration, aseptic filling into vials/syringes, and optional lyophilization in automated filling lines. ⑦QC Release & Stability: The finished DP undergoes full QC testing (potency, purity, sterility, particulates, endotoxin). Batch release is granted, and stability studies are initiated. |
☞Large Scale Industrial Service Technology Resources
Our platform is powered by world-class infrastructure and technological capabilities:
①Manufacturing Assets: Multiple, segregated cGMP production suites housing large-scale stainless steel and single-use bioreactors (up to 15,000L), automated chromatography skids (ÄKTA ready), and high-speed fill-finish lines with isolator technology.
②Core Technology Platforms:
● Microbial Fermentation: High-density E. coli and yeast fermentation platforms.
● Mammalian Cell Culture: High-titer CHO and HEK293 platforms, including fed-batch and perfusion processes.
● Advanced Purification: Expertise in multi-column chromatography, continuous downstream processing, and novel separation technologies.
● Analytical & Characterization: Fully equipped labs for SEC/UPLC, CE-SDS, LC-MS, glycan analysis, PCR, and a full suite of potency assays (cell-based, ELISA, SPR).
③Quality & Compliance Systems: A comprehensive Quality Management System (QMS) aligned with global cGMP standards (FDA, EMA, PMDA), including electronic batch records (EBR), LIMS, and validated computer systems.
④Supply Chain & Logistics: Integrated warehousing, cold-chain management, and global distribution capabilities to deliver your product anywhere in the world.
☞Nebulabio Service Process
Our collaborative engagement model is designed for strategic partnership and project success.
Process Steps Description:
● Strategic Partnership & Proposal: We engage in a high-level strategic discussion to understand your long-term goals. A detailed business proposal and project charter outlining scope, governance, and financials are established.
● Technical Development & Process Characterization: Our process development teams optimize and characterize the manufacturing process, defining the design space and control strategy.
● Capillary Alignment & Tech Transfer: Joint teams from both companies align on every technical and operational detail. A formal, document-driven tech transfer ensures flawless knowledge translation to the commercial site.
● Capital & Campaign Planning: We plan and schedule the commercial campaign, ensuring all raw materials, facility time, and personnel resources are secured. Capital projects for specific equipment are executed if needed.
● GMP Campaign Execution: The commercial batch is manufactured under strict cGMP with full documentation. Regular governance meetings ensure transparency and rapid issue resolution.
● Quality Release & Logistics: The batch is reviewed and released by Quality Assurance. Our logistics team manages cold-chain shipping and delivery to your designated global locations.
● Lifecycle Management & Continued Supply: We transition to a supply partnership, managing ongoing production campaigns, process monitoring, and continuous improvement to ensure a decade of reliable supply.
☞Your Strategic Partner for Industrial Biomanufacturing
Choose Nebulabio Industrial-Scale Customization Platform to access a unique blend of scientific agility, proven manufacturing excellence, and true partnership. We are committed to being an extension of your team, providing the strategic vision and operational power to bring your biologic innovations to patients and markets worldwide.
Contact Nebulabio’s business development team to begin a strategic dialogue about your commercial-scale needs.
For more information, please contact us at info@nebulabio.cn or +86-15801534258.
