Fill & Finish

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• The Sterile Fill & Finish for Biologics is a crucial step in the manufacturing process, where the utmost precision, sterility, and quality assurance are required to ensure that the drug product reaches patients safely and effectively. With our extensive experience in biologics production and a proven track record of successful projects, Mabion offers comprehensive Fill & Finish services tailored to meet the unique needs of each client. Our fully integrated solutions encompass every aspect of this complex process, from vials sterilization to secondary packaging and serialization.
• At Mabion, we prioritize minimizing risk and ensuring compliance with global regulatory standards, using state-of-the-art equipment and rigorous process validation for Fill & Finish services to guarantee the highest quality standards at every stage. We employ a risk-based approach to validation, ensuring that all critical control points are meticulously monitored and documented. This focus on quality and compliance ensures that your product is manufactured in a way that meets all regulatory expectations and delivers on patient safety and efficacy.
• At Mabion we specialize in the advanced manufacturing of biologics, leveraging extensive expertise alongside cutting-edge technologies. Our outstanding production capabilities span the entire manufacturing process, from cell culture to fill & finish, allowing us to consistently deliver high-quality products.
• One of Mabion’s key strengths lies in the ability to integrate Fill & Finish seamlessly with our full range of biologics manufacturing services. By choosing us as your partner, you benefit from a streamlined, end-to-end process that covers everything from upstream and downstream processing to final product packaging and serialization. This integrated approach reduces handovers, mitigates potential delays, and ensures consistent quality control, all while optimizing timelines and costs. However, we also offer Fill & Finish as a separate, stand-alone service.
• Our Fill & Finish offer covers different types of biologics (proteins, peptides, enzymes, nucleic acids, diluents, placebos) as well as non-biologic small molecule drugs.

Once complete, the Fill & Finish process for your product is validated by our expert team, in compliance with the international regulatory standards.

Our equipment

Mabion’s facility is equipped with cutting-edge technology designed for high throughput and flexibility. We offer a variety of vial sizes and packaging options to meet diverse market needs, realizing that modern era biologics are being administered in progressively smaller doses. Our state-of-the-art inspection systems ensure that every vial is thoroughly examined for defects, particles, and integrity, providing you with confidence in the quality and safety of your product. Additionally, our serialization capabilities are designed to meet the latest global requirements, giving you a competitive edge in an increasingly regulated market.

Our advanced technology ensures that your product is filled, stoppered, and capped with unparalleled accuracy and consistency, safeguarding its therapeutic efficacy and patient safety.

Automatic vial filling line

Mabion’s Sterile Fill & Finish for Biologics services are powered by a sophisticated automatic filling line capable of handling fill volumes ranging from 0.2 to 100 ml, offering unmatched versatility for a variety of biologic products. Whether your project involves small-scale clinical trial batches or large-scale commercial production, our equipment is designed to accommodate your specific requirements with ease. Our filling line is optimized for high throughput and minimal product loss, ensuring that each batch is processed efficiently while maintaining the highest standards of sterility and precision.

• Mabion operates a fully automated aseptic filling line featuring isolator technology, which represents the pinnacle of modern pharmaceutical manufacturing. This advanced technology ensures the production of sterile products in a contamination-free environment. The filling line consists of several key components, including a vial washing machine, a depyrogenation tunnel, a vial filling line, and a vaporized hydrogen peroxide (VHP) generator. The system is designed to accommodate a wide range of vial formats from 2R to 100R, with the ability to achieve various filling capacities, such as processing up to 6,000 vials per hour for 10 mL vials.
• The vial filling line is connected to the VHP generator which performs the bio-decontamination of the isolator interior using hydrogen peroxide. Prior to each VHP cycle, the integrity of the device is verified with a leak test, derisking potential contamination that could compromise the drug product. During aseptic filling, single-use dosing systems and sterile ready-to-use packaging materials (stoppers and caps) are utilized. All materials are introduced or removed from the isolator via rapid transport ports. The filling line is equipped with various sensors that provide 100% control of the vial product weight, detect the presence of stoppers and caps, monitor laminar flow speed and check environmental parameters such as temperature, humidity and pressure inside the machine.

Vial sterilization

Vial format	2R to 1000R
Capacity	6,000 vials/hr (10 mL)
Rooms	C-A class (local) room
Equipment	Washing machine Depyrogenation tunnel

Mabion provides a versatile vial sterilization service that can accommodate a wide range of vial formats, from 2 ml to 100 ml. This flexibility allows us to support diverse product types, including small-volume injectable biologics, large-volume parenterals, and other complex formulations. Our sterilization processes are optimized to handle different vial sizes and types with precision and care, ensuring that each vial is properly sterilized and ready for the subsequent stages of the Fill & Finish process. Whether you are developing a new biologic therapy or scaling up production for commercial supply, Mabion has the expertise and capacity to meet your specific vial sterilization needs.

• To ensure efficiency and meet the demands of both clinical and commercial manufacturing, Mabion operates a high-capacity sterilization line with the ability to sterilize up to 6,000 vials per hour.
• Mabion’s sterilization services are conducted in a dedicated C-A class (local) cleanroom environment, equipped with cutting-edge technologies to ensure the highest levels of sterility and contamination control. The cleanroom is designed and maintained in accordance with cGMP and international regulatory standards, providing an optimal environment for the preparation and sterilization of vials.
• The depyrogenation tunnel is a key component of our sterilization process, offering a highly controlled environment where vials are exposed to temperatures exceeding 300°C. By employing a depyrogenation tunnel, Mabion ensures that all vials meet the highest standards of sterility and pyrogen-free status, providing you with complete confidence in the safety and quality of your biologic products.

Vial filling

Fill volumes	2 – 100 mL
Capacity	Up to 6,000 vials/hr
Products	Biologics and non-biologics

Mabion’s Sterile Fill & Finish for Biologics services are powered by a sophisticated automatic vile filling line capable of handling fill volumes ranging from 2 to 100 mL, offering unmatched versatility for a variety of biologic products. Whether your project involves small-scale clinical trial batches or large-scale commercial production, our equipment is designed to accommodate your specific requirements with ease. Our vile filling line is optimized for high throughput and minimal product loss, ensuring that each batch is processed efficiently while maintaining the highest standards of sterility and precision.

• Mabion operates a fully automated aseptic vile filling line featuring isolator technology, which represents the pinnacle of modern pharmaceutical manufacturing.
• This advanced technology ensures the production of sterile products in a contamination-free environment. The filling line consists of several key components, including a vial washing machine, a depyrogenation tunnel, a vial filling line, and a VHP generator.
• The system is designed to accommodate a wide range of vial formats (2 mL to 100 mL), with the ability to achieve various filling capacities, such as processing up to 6,000 vials per hour for 10 mL vials.
• The vial filling line is connected to the VHP generator which performs the bio-decontamination of the isolator interior using hydrogen peroxide. Prior to each VHP cycle, the integrity of the device is verified with a leak test to verify its integrity, derisking potential contamination that could compromise the drug product.
• During aseptic filling, single-use dosing systems and sterile ready-to-use packaging materials (stoppers and caps) are utilized. All materials are introduced or removed from the isolator via rapid transport ports.
• The filling line is equipped with various sensors that provide 100% control of the vial product weight, detect the presence of stoppers and caps, monitor laminar flow speed and check environmental parameters such as temperature, humidity and pressure inside the machine.

Packaging and Serialization

Mabion’s offer includes secondary packaging, labelling and serialization of the finished drug product (vials for intravenous use). These comprehensive services are designed to provide maximum protection for your products while enhancing supply chain transparency and security.

Serialization is an essential aspect of modern pharmaceutical manufacturing, particularly for biologics, where patient safety and product traceability are paramount. At Mabion, we provide comprehensive serialization services that comply with global regulatory requirements.

A detailed overview of the packaging parameters is provided in the table below.

Parameters	50 mL	10 mL	2 x 10 mL
Unit package dimension [mm]	49.50 x 54.50 x 80.00	49.50 x 36.00 x 63.00	49.50 x 36.00 x 63.00
Box dimension [mm]	265.00 x 230.00 x 257.00	212.00 x 193.00 x 200.00	212.00 x 193.00 x 200.00
Quantity in one case (box)	60 (60 vials)	60 (60 vials)	60 (120 vials)
Quantity of layers on pallet	4 layers	4 layers	4 layers
Quantity of cases (boxes) on pallet	36 cases (boxes)	80 cases (boxes)	80 cases (boxes)
Quantity of unit packages on pallet	2,160	4,800	4,800
Quantity of vials on a pallet	2,160	4,800	9,600
Time of packaging + T&T Level 4	50 vials/min	50 vials/min	60 vials/min
Dimensions of pallet [cm]	120.00 x 80.00 x 126.00	120.00 x 80.00 x 104.80	120.00 x 80.00 x 104.80
Gross weight of pallet	258 kg	205 kg	378 kg

Product Inspection

Visual inspection	Automatic (inspection line) or manual (qualified personnel) Up to 6,000 vials per hour
Leakage testing	100% leak test on every vial

As part of our comprehensive Fill & Finish services, we offer drug product inspection capabilities designed to detect and eliminate any defects or inconsistencies before your product reaches the patient. All filled, stoppered and capped vials undergo a visual inspection and rigorous leakage testing. With a focus on accuracy, efficiency, and compliance, our advanced inspection systems provide complete assurance that every vial meets the highest industry standards.

• Vials can be inspected either automatically using a dedicated inspection line or manually by qualified personnel. Both visual inspection and leakage testing is carried out on 100% of the filled vials. The fully automated vial inspection line achieves capacities comparable to the filling line, e.g. processing up to 6,000 vials per hour for 10 mL vials.
• By performing a 100% leak test on every vial, we ensure that the container closure is intact and provides the necessary barrier against microbial contamination and environmental exposure. This meticulous approach helps maintain the sterility and stability of your biologic product, safeguarding its efficacy throughout its shelf life.
• We utilize a combined leak and visual inspection line for maximum quality control. This dual-function system allows us to thoroughly inspect each vial for a wide range of potential issues, including container closure integrity, particulate contamination, cosmetic defects, and other critical quality attributes. By integrating these two inspection processes into a single line, we achieve comprehensive quality control, reducing the risk of a defective product reaching the market.

Full in-process and release testing

Comprehensive in-process and release testing is fundamental in ensuring the safety, efficacy, and quality of biologic drug products. As part of our Sterile Fill & Finish for Biologics service package, we offer a complete suite of testing services that are designed to meet stringent regulatory requirements and provide you with confidence that your product is ready for clinical use or commercial launch. Our full panel of in-process and release testing services is tailored to the specific needs of each project, leveraging our advanced analytical capabilities, robust quality systems, and deep expertise in biologics manufacturing.

Release testing of Drug Substance

• Mabion provides thorough release testing of both the drug substance and the final drug product to ensure they meet all required quality specifications before being approved for use. Our testing includes analysis of identity, potency, purity, and safety, as well as physical and chemical properties that are critical to the performance of your biologic. By employing state-of-the-art analytical techniques, such as HPLC, ELISA, mass spectrometry, and capillary electrophoresis, we deliver precise and accurate data that supports regulatory submissions and product release.

Testing of intermediate products and in-process pools as part of the control strategy

• We conduct rigorous testing at critical stages throughout the manufacturing process to ensure consistency, quality, and compliance with predefined specifications. This proactive approach allows us to identify and address any potential issues early in the production process, minimizing risk and enhancing overall product quality.

Raw materials release testing

• We perform extensive raw materials release testing to ensure that all components used in the manufacturing process meet the highest standards of quality and purity.

QP release of Drug Product

• To comply with European regulatory requirements, Mabion provides Qualified Person (QP) release services for drug products. Our QPs have the experience and authority to certify that each batch of drug product has been manufactured in accordance with current Good Manufacturing Practices (cGMP) and meets all regulatory and quality standards. Mabion’s QC unit performs DP release for the US and other markets.
• Our QPs and QC units work closely with our clients to provide guidance throughout the release process, ensuring full compliance with all regulatory obligations and providing our clients the assurance that their product is ready for distribution.

Stability testing (in-process samples, intermediates, drug substance and drug product)

• Stability of our client’s biologic product is essential to determining its shelf life, storage conditions, and packaging requirements. Mabion offers comprehensive stability testing services for in-process samples, intermediates, drug substance, and final drug product. Our stability studies are conducted under ICH guidelines and include both real-time and accelerated conditions to assess the impact of various environmental factors on product quality.

Biosafety testing (Sterility and Bioburden, Mycoplasma, and Endotoxin)

• We perform rigorous biosafety testing, including sterility and bioburden testing, mycoplasma detection, and endotoxin analysis. Our sterility and bioburden testing is designed to detect the presence of viable microorganisms in the drug product, while mycoplasma testing using real-time qPCR identifies any contamination by mycoplasma species that could compromise product safety. Endotoxin analysis, conducted using the Limulus Amebocyte Lysate (LAL) assay, ensures that the levels of bacterial endotoxins are within acceptable limits. These biosafety tests are performed in compliance with international guidelines, ensuring the highest level of product safety and patient protection.

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