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For contract development and manufacturing organizations (CDMOs), strategic decisions are driven by evolving market demands and customer expectations. Flexibility in fill-and-finish operations is therefore a key success factor – especially for emerging companies like August Bio. To support this, Optima is delivering three systems: One for pre-filled syringes and cartridges, one for vial filling, and a third for assembling protective components on pre-filled syringes. The systems are designed with flexibility in mind – delivering performance while enabling adaptability across a wide range of applications.
All CDMOs pursuing fill-finish equipment have one common objective: Flexibility. However, that’s often where the similarities end. The definition of “flexibility” varies widely – even within the fill-finish segment. Optima’s portfolio reflects this diversity. It offers a broad range of system types and configuration options, offering solutions that are typically tailored to the specific needs of each customer.
At first glance, August Bio’s decision to implement a separate line for vials and a separate line for pre-filled syringes and cartridges may appear unconventional. However, both lines are designed for maximum output, making them ideally suited for processing large batch sizes. If syringes are processed, they can then be completed fully automatically on an assembly line for safety components. These components are essential for applications such as self-administration or the protection of healthcare personnel.
For the processing of pre-filled syringes and cartridges, August Bio selected the OPTIMA H6-10. Initially configured for the most common syringe and cartridge formats, the system offers upgrade capabilities that allow for seamless adaptation to volumes ranging from 0.5 to 10 ml and their corresponding container types.
A key feature of the line is the integrated combi filling module, which offers significant flexibility for handling a wide range of liquid pharmaceutical products. This module includes a 10-lane peristaltic pump and 10-lane rotary piston pump system, efficiently integrated within a compact design. Switching between the two filling technologies requires only minimal mechanical adjustment. Once the desired recipe is selected via the HMI, servo-driven components handle most of the process automatically. This offers smooth transitions between different product types, whether dealing with higher viscosities, shear-sensitive active ingredients, or formulations requiring high output. As a result, August Bio is well equipped to ensure high-quality, reliable processing for a diverse range of customer requirements.
The OPTIMA H6-10 fills nested pre-filled syringes row-by-row, achieving a maximum output of up to 36,000 syringes per hour (without IPC). Filling accuracy is continuously monitored using a statistical in-process control (IPC) system. Depending on the selected IPC level, a full row of empty cartridges or syringes is removed from each nest for tare weight measurement. After the filling process, the same row is checked again at a separate weighing station to verify the individual fill weights.
If deviations outside the defined tolerance range are detected, the OPTIMA SIRM inline inspection system enables targeted inter¬vention, either by rejecting individual syringes or, if necessary, the entire nest at the end of the process. The in-process control system plays a key role in optimizing filling accuracy. Should the fill weight at a specific dispensing point begin to trend away from the target, the system recognizes this statistical deviation and automatically adjusts the process parameters to maintain consistent dosing precision.
The OPTIMA H6-10 fills nested pre-filled syringes row-by-row, achieving a maximum output of up to 36,000 syringes per hour (without IPC). Filling accuracy is continuously monitored using a statistical in-process control (IPC) system. Depending on the selected IPC level, a full row of empty cartridges or syringes is removed from each nest for tare weight measurement. After the filling process, the same row is checked again at a separate weighing station to verify the individual fill weights.
If deviations outside the defined tolerance range are detected, the OPTIMA SIRM inline inspection system enables targeted inter¬vention, either by rejecting individual syringes or, if necessary, the entire nest at the end of the process. The in-process control system plays a key role in optimizing filling accuracy. Should the fill weight at a specific dispensing point begin to trend away from the target, the system recognizes this statistical deviation and automatically adjusts the process parameters to maintain consistent dosing precision.
The filling system also features dedicated start-up and empty modes. At the beginning of a batch, each container is individually filled on load cells until the precise target weight is reached. At the end of the batch, the system continues operating in a controlled manner, minimizing the risk of underfilling the syringes or cartridges. This functionality ensures optimal use of the available product volume.
The previously mentioned OPTIMA SIRM inspection module performs a precise check of the stopper position in each pre-filled syringe or cartridge, a critical parameter for self-administration systems. Correct stopper positioning is essential to ensure safe and reliable patient use. Following inspection, the syringes can be transferred to the Optima syringe assembly system, where they are assembled into ready-to-use formats. This will be presented below.
The dedicated vial line includes an OPTIMA VFVM18000 filling machine and the OPTIMA VVM36000 closing machine. Vials are manually unpacked, wet-cleaned in a washing machine, and sterilized in a sterilization tunnel. An integrated ionization unit neutralizes static charges on each vial, eliminating potential interference during subsequent tare weighing and ensuring consistently accurate fill weights. Dosing is performed by a 10-lane control system utilizing a compact yet powerful multi-stack peristaltic pump arrangement. During stoppering, the vials are optionally gassed, followed by crimping, and then automatically stacked into trays for downstream processing.
After the sterilization tunnel the vials are transferred to be individual processed. Next station: De-ionization.
The System offers 3 options: Active rejection of "bad" syringes, active discharge of "good" syringes, and optional transfer for storage of pre-filled syringes
Crimp cap present check.
The line is capable of processing up to 24,000 vials per hour. Each vial undergoes individual fill weight verification as part of a comprehensive 100% in-process control system. This offers immediate detection of underfills, ensuring rigorous quality assurance throughout the production process.
A dedicated start-up mode maximizes the use of available pharmaceutical product by filling vials directly on the load cell until the system verifies stable operation. This eliminates the typical rejection of underfilled vials that often occur at the beginning of a batch. Similarly, during the end-of-batch phase, vials continue to be filled on the load cell, allowing production to proceed safely until the last drop of product is used. Any underfilled vial at the batch’s conclusion is accurately identified and rejected. This approach ensures efficient production throughout all batch phases, combining high output with optimal product utilization.
The line is capable of processing up to 24,000 vials per hour. Each vial undergoes individual fill weight verification as part of a comprehensive 100% in-process control system. This offers immediate detection of underfills, ensuring rigorous quality assurance throughout the production process.
A dedicated start-up mode maximizes the use of available pharmaceutical product by filling vials directly on the load cell until the system verifies stable operation. This eliminates the typical rejection of underfilled vials that often occur at the beginning of a batch. Similarly, during the end-of-batch phase, vials continue to be filled on the load cell, allowing production to proceed safely until the last drop of product is used. Any underfilled vial at the batch’s conclusion is accurately identified and rejected. This approach ensures efficient production throughout all batch phases, combining high output with optimal product utilization.
Flexibility is clearly demonstrated in the wide range of vial formats August Bio can process, spanning sizes from 2R to 100H. Minimizing format changeover times is a key objective, supported by features such as pneumatic locking devices on the sorting bowls. Most format adjustments are initiated via the HMI and executed automatically by the system. With these optimized processes, two to three operators can complete a format change within approximately 30 minutes, ensuring high operational efficiency.
Flexibility is clearly demonstrated in the wide range of vial formats August Bio can process, spanning sizes from 2R to 100H. Minimizing format changeover times is a key objective, supported by features such as pneumatic locking devices on the sorting bowls. Most format adjustments are initiated via the HMI and executed automatically by the system. With these optimized processes, two to three operators can complete a format change within approximately 30 minutes, ensuring high operational efficiency.
The OPTIMA SH110 syringe assembly line is the third system Optima has delivered to August Bio as part of an integrated solution. Nested, filled syringes are first removed from their nests via a pick-and-place system and processed individually. Plunger rods are then attached and pressed in, followed by labeling and printing. Subsequent stations handle the multi-step assembly of safety devices and finger flanges. After comprehensive quality and functional checks, a six-axis robot carefully picks and places the inspected syringes into plastic trays. Designed for flexibility, the compact SH110 accommodates syringe diameters up to 30 mm and heights up to 150 mm. Ultimately, all three systems will be integrated under a centralized Optima SCADA system.
Optima successfully completed the iFATs for both fill-and-finish lines in February, each within one week. The two lines, one for vials and one for syringes and cartridges, were ready for shipment to the USA at the end of March.
Even before shipment of the lines, Optima visited August Bio’s facilities in Nashville, TN, to develop a comprehensive move-in strategy. A distinctive aspect of this project is that the operating building was specifically designed to house the three existing lines and potentially additional ones in the future. Despite these favorable conditions, thorough and structured preparation remains essential to ensure a rapid and seamless commissioning process on site. As of June 2025, installation of both lines was nearly complete, followed by their commissioning. Completion is expected by October/November 2025. The Factory Acceptance Test (FAT) for the syringe assembly machine was scheduled for the end of July 2025.
The three Optima systems at August Bio will be connected to a higher-level SCADA System
Final: Safety components are assembled, pre-filled syringes are labeled, printed and automatically stored in trays
Once a growing startup, August Bio has rapidly evolved into a recognized leader in the CDMO industry, delivering large-scale pharmaceutical solutions. Michael Scribner, Chief Operating Officer, and Jason Hartman, Vice President of Engineering and Facilities, share the reasons behind August Bio’s decision to select three Optima systems: First, Optima’s turnkey solution was a decisive factor in their investment decision. Additionally, Jason Hartman highlights the extensive in-house testing conducted during the iFAT phase, which allows for a highly targeted and comparatively shorter commissioning period at August Bio’s facility.
Establishing a reputation as a reliable, high-quality partner within the pharmaceutical industry is equally important. This commitment is reinforced by collaborating with trusted partners for fill-finish hardware. “We earn customer trust not only through our strategy but also through Optima’s strong reputation as a trusted industry leader,” says Michael Scribner. Jason Hartman adds that he is confident Optima will support August Bio’s upcoming growth journey with cooperative and transparent collaboration throughout all phases.
The integrated combi filling module offers flexibility for a wide range of product characteristics.
August Bio aims to meet both its own and its customers’ needs comprehensively, providing end-to-end solutions. This commitment to flexibility encompasses several aspects: Accommodating different container types, offering diverse filling systems tailored to various drug formulations, and delivering performance capacities that support any batch size. “Our customers should be able to scale their business with us,” says Michael Scribner. He adds, “As a CDMO, we must be agile and capable of quickly adapting to evolving market demands.”
Jason Hartman further highlights additional factors that influenced August Bio’s decision to select Optima’s solutions: The strong commitment to innovation demonstrated by Optima’s engineering team, and the operational efficiency of the system design. Equally important were the advanced operating and maintenance software and the digital tools provided for troubleshooting support. The proximity of the Optima Center of Excellence in North Carolina, just a few hours from August Bio’s Nashville facility, offers valuable training and spare parts services. “All of these factors, along with other benefits, provide us with the best possible foundation to successfully grow our business with the three systems,” Hartman concludes.
