uBriGene's aseptic fill-finish systems ensure consistent, high-quality output for advanced therapies, minimizing contamination risks, reducing costs, and accelerating production timelines.
uBriGene brings extensive expertise in aseptic fill and finish for advanced therapy medicinal products (ATMPs), including plasmids, AAV, LVV, RNA-LNP, and cell products. As a leading global CDMO for ATMP, we have a strong track record of GMP manufacturing and filling drug substances and products in full compliance with the highest regulatory standards.
Strong fill-finish track records
Flexible systems, (semi-)automated & manual filling
Expertise in ATMP fill-finish processes
Our cutting-edge facilities provide flexible options for fully automated, semi-automated, and manual filling lines, meeting different needs from preclinical, clinical, to commercial stages.
This fully automated line integrates vial feeding, filling, stoppering, and capping. It uses a peristaltic pump for accurate filling, all controlled by a user-friendly HMI interface.
Speed: 1,200-1,500 vials per hour
Fill Volume Range: 0.5-50 mL
Filling Accuracy: ≤ ±1% (for volumes > 2 mL)
This flexible line accommodates various packaging formats (vials, syringes, ampoules) with optional gas-flushing systems and automatic cap screwing. It is ideal for small-scale production and diverse product types.
Speed: 300-500 vials per hour
Fill Volume Range: 0.1-50 mL
Filling Accuracy: ±1% (for 1 mL)
uBriGene also offers automated filling into freezing bags, ideal for cell and virus dispensing. This system ensures high precision while maintaining product stability and reducing labor costs.
Fill Volume Range: 2-150 mL
Intelligent fluid flow control for precise filling
Supports up to 20 bags per cycle
Maintains low temperatures to preserve cell activity
Aseptic fill-finish of ATMP products for clinical use is a complex process that ensures the sterility and efficacy of drug products. Additionally, the filling process must adhere to strict GMP regulatory guidelines.
Adequately trained personnel with experience in aseptic processes
Access to specialized fill-finish equipment
Formulation development capabilities to ensure the stability and efficacy of drug products prior to aseptic filling
In-depth knowledge of aseptic fill-finish regulatory standards
The aseptic filling process ensures the sterility and quality of drug products through a series of carefully controlled steps.
It begins with comprehensive preparation, including personnel training, equipment validation, material testing, and process transfer. Aseptic filling simulation or validation follows to ensure process integrity. If applicable, the drug product undergoes preparation and sterile filtration before being filled into containers.
After filling, the product is inspected, packaged, and stored, followed by rigorous testing and final release to ensure compliance with regulatory standards.
Aseptic fill-finish workflow.
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Aseptic fill-finish, also known as sterile fill-finish, is the process of filling sterile containers such as vials, bags, or syringes with drug substances (DS) or drug products (DP) in a clean room environment. It is a critical step in manufacturing advanced therapies, ensuring the sterility and safety of the final product.
Yes, we specialize in aseptic fill-finish for cell and gene therapy products, including plasmids, AAV, LVV, RNA-LNP, and cell therapy products. This includes the final formulation and filling of CGT materials in a compliant, sterile environment.
uBriGene supports aseptic fill-finish under a GMP framework, with a quality management system and in-house quality testing. The website lists compliance with FDA, EMA, and NMPA requirements; applicable requirements depend on the product and target market.
uBriGene offers aseptic fill-finish options for preclinical, clinical, and commercial-stage programs, with automated, semi-automated, and manual filling systems tailored to product and batch requirements.
Yes. uBriGene offers automated and semi-automated filling lines for different production needs. The automated line operates at 1,200–1,500 vials per hour, with fill volumes of 0.5–50 mL; the semi-automated line operates at 300–500 vials per hour, with fill volumes of 0.1–50 mL.
uBriGene offers fully automated, semi-automated, and manual filling systems, plus an automated sterile bag filling system for cell and virus dispensing. The automated vial line integrates vial feeding, filling, stoppering, and capping; the semi-automated line supports vials, syringes, and ampoules. Our facilities are equipped to handle complex formulations such as RNA-LNP, viral vectors, and cell therapies.
Our aseptic fill-finish process is supported by a comprehensive Quality Management System (QMS). We conduct in-house quality testing throughout the manufacturing process to ensure product safety, potency, and regulatory compliance.
uBriGene supports vials, syringes, ampoules, and freezing bags. Fill-volume ranges are 0.5–50 mL for the automated vial line, 0.1–50 mL for the semi-automated line, and 2–150 mL for the sterile bag filling system.
Sterile filtration removes microorganisms from compatible liquid products using a sterilizing-grade filter, when appropriate for the product. Aseptic fill-finish transfers the sterile product into final containers under controlled conditions to minimize contamination risk. Sterile filtration may precede filling, but it is not suitable for every cell and gene therapy product.
uBriGene supports aseptic filling through controlled cleanroom operations, a GMP quality management system, and in-process quality controls. Equipment and processes must be appropriately qualified or validated, with contamination-control measures established for the product and filling system. Specific controls depend on the product, container format, and manufacturing requirements.
Yes. uBriGene offers an automated sterile bag filling system for cell and virus dispensing, with fill volumes of 2–150 mL and up to 20 bags per cycle. The system supports low-temperature filling to help preserve cell activity during processing.
