Choose Eurofins’ new state-of-the-art aseptic sterile fill/finish for clinical supplies

by Joe Page, Ph. D., President, Eurofins Advantar Laboratories Inc.

Industry changes, such as shorter timelines and increased product complexity, can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns.

Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 trials at its San Diego, CA, laboratory.

Using state-of-the-art isolator and robotic technology provided by the Vanrx Microcell vial filler, this facility can produce small batches (up to 3000 vials) of sterile GMP or GLP products (biologics, large and small molecules) for clinical or toxicology studies. Clients can provide bulk drug products for sterile filtration and filling, or Eurofins Advantar can perform compounding, sterile filtration, and filling.

The Microcell Vial Filler is a fully integrated isolator that fills vials with precise fill volumes and automatically caps and weighs vials in rapid cycles. This gloveless, closed-isolator is Part 11 compliant, and its robotic operation is designed to reduce human error, time, and contamination. Key features of this fill-finish isolator include: a vapor phase hydrogen peroxide (VPHP) decontamination cycle; use of depyrogenated, sterile, ready-to-use vials (sizes 2, 4, 6, 8, 10, 15, 20, 25, 30 and 50 mL); snap cap lids that replace traditional metal crimps lowering the potential for particulate matter contamination; ability to fill variable volumes (0.2 to 50 mL); in-process weight checks; single use fill lines; and needles that allow for rapid switching between product types.

This system is ideally suited for high value products with minimum product hold up in the low-volume fill line and right-sized surge bags; non-destructive weight checks conserve vials. In addition to eliminating cross-contamination, single-use bulk bags, fill lines, and fill needles enable rapid switching (within one day) between filling different variants within a product platform, or across product lines. The system is adaptable to BSL2 filling for gene therapy and biologic products needing additional isolation not provided by traditional filling lines. Cyclic olefin copolymer (COC or COP) vials may be used in the system to improve clients’ products availability by limiting binding to the vial walls. These precisely manufactured vials improve the container closer integrity, and the copolymer prevents breakages even at low storage temperatures (-80°C).

In addition to sterile filling, the San Diego site offers a range of services to support the design and production of clinical supplies. Experienced formulation scientists can perform preformulation, formulation, and excipient screening experiments to determine an optimal formulation. Concentration and buffer exchange for biologics can be developed and optimized on a UF/DF system. Filter selection and sterile filtration development can be performed. Final formulations are prepared according to an approved batch record, and sterile filtration occurs in an ISO5 hood using single-use, pre-sterile, closed filtration systems that utilize Readymate^® aseptic connectors. Analytical methods can be developed and validated to enable GMP release and stability studies for the filled vials. With a full offering of mapped, ICH compliant stability chambers (-80°C, -40°C, -20°C, 2 to 8°C, 25°C /60% RH, 30 °C/65% RH, and 40°C/75% RH) samples can be held at Eurofins Advantar for the duration of your stability study. Eurofins’ FDA inspected laboratory can hold and test GMP supplies, and its QA department can approve clients’ supplies for clinical use. Depending on the final use, Eurofins has an SOP driven clinical packaging operation that is available to clients who may need their vials labelled, blinded, or assembled into kits. These vials are held under designated conditions and shipped with validated shippers to the clinical sites. Learn more about Eurofins’ agility to support sterile fill/finish manufacturing of small batches, including personalized medicines at www.eurofins.com/biopharmaservices/product-testing/services/sterile-fillfinish-manufacturing/