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 ATMPs, we have a strong track record of GMP manufacturing and filling drug substances and products in full compliance with the highest regulatory standards.
Consult with us for seamless IND submissions, regulatory compliance, and cutting-edge technology in CAR-NK and CAR-T CDMO manufacturing services.
Sit aliquam elit vitae bibendum lectus blandit dictum. Nisi porta elementum sed diam eleifend pellentesque. Quis aenean quam.
Request a Quote
Optional caption section: This caption text can be used under any image or content block as-needed. Use cases are figure legends, citations, image descriptions
Optional caption section: This caption text can be used under any image or content block as-needed. Use cases are figure legends, citations, image descriptions
Strong fill-finish track records
Flexible systems, (semi-)automated & manual filling
Expertise in ATMP fill-finish processes
These advantages not only improve the efficiency and reliability of the manufacturing process but also ensure a more cost-effective production of cells.
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 advantages of membrane matrix in downstream chromatography for plasmid purification include requiring only 30% of the time compared to conventional resin. Therefore, plasmid DNA is manufactured faster and at a much lower cost.
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.
Request a quoteLearn about uBriGene’s advanced therapy CDMO capabilities.
Learn about CAR-T production process & regulatory guidelines.
Unveil the current manufacturing approaches for LVV and its deployment in cell therapies.
Discover our AAV manufacturing capabilities, scalable processes, and testing platform.
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.
As a global leader in ATMP CDMO services, uBriGene operates under a robust GMP framework and complies with FDA, EMA, and other regulatory standards. Our aseptic fill-finish services adhere to the highest regulatory requirements to ensure product safety and quality.
uBriGene has a proven track record of GMP manufacturing and aseptic fill-finish for drug substances and drug products across a range of advanced therapies. Our experience spans from early clinical batches to large-scale commercial production.
Yes, our scalable processes allow us to support both small clinical batches and large-scale commercial production. We offer flexible fill volumes and batch sizes to meet the specific needs of each client.
We use advanced fill-finish technologies in a controlled clean room environment, ensuring sterility and minimizing contamination risks. 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.
To learn more about our aseptic fill-finish services or to discuss your specific project needs, please contact us directly. Our team will work closely with you to provide tailored solutions for your ATMP manufacturing requirements.
Take the next step in your CAR journey. Discuss your project requirements and see how our CAR-NK & CAR-T CDMO services can support your goals.
Sit aliquam elit vitae bibendum lectus blandit dictum. Nisi porta elementum sed diam eleifend pellentesque. Quis aenean quam.
Request a Quote
Optional caption section: This caption text can be used under any image or content block as-needed. Use cases are figure legends, citations, image descriptions
Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
