Amgen presents on next-generation bioprocessing technologies at AAPS Pharma 360
On November 6, Dr. Nitin Rathore, Director of Process Development at Amgen, presented Implementation of Next-Generation Technologies in Biomanufacturing at the American Association of Pharmaceutical Scientists (AAPS) Pharma 360 conference in Washington, D.C.
Assessing next-generation filling systems for operational and business needs
Dr. Rathore’s presentation detailed an operational assessment of two next-generation aseptic filling systems, including Vanrx’s SA25 Aseptic Filling Workcell. Both systems are installed at Amgen’s Thousand Oaks, California facility.
The assessment was conducted to determine how the filling systems could help meet business needs in an environment of high-mix, low-volume manufacturing. In this model, Dr. Rathore evaluated the use case for a greater number of product configurations with smaller market volume requirements.
From a business perspective, filling technologies need to be less costly, and enable the company to match production to the forecast with a smaller margin of error. The technologies would support a scale-out model of adding capacity quickly when needed.
From an operational perspective, new aseptic filling technologies need to require less space, have the flexibility for different dosage formats, and changeover and decontaminate quickly. They need to support more rapid technology transfer and minimize required cleaning infrastructure.
Assessment of the SA25 Aseptic Filling Workcell
Dr. Rathore highlighted the elegant design of the SA25 and noted that the development of a gloveless isolator represented a “paradigm shift”. The presentation cited the machine’s capacity at one to two million units annually (for 2R vials), and the machine needed only two operators for filler operation. He singled out the machine’s changeover and decontamination times as significant improvements versus past filling machinery and barrier systems. The SA25 was also called “adaptable” for its ability to fill different dosage formats.
Dr. Rathore’s presentation on the SA25 concluded that the machine was aligned with its process performance requirements, with data shown to support various criteria. Further study is needed at commercial production quantities to determine by how much this robotic filling system lowers the number of interventions in the aseptic filling process.
Since gloveless robotic isolators differ from past filling machinery, it was identified that adoption of the SA25 would require proactive communication with regulators. Vanrx is coordinating this effort through its User Group, with both Vanrx and customers generating and sharing data to support regulatory submissions.
Dr. Rathore also said that optimization was needed on lyophilization cycles for vials that remain in ready-to-use nests in combination with nested press-fit closures. He did note that a viable lyo process was achievable on a lab-scale for the nested closures as they did not pose an undue resistance to vapor flow during lyo cycles. Differences between nest configurations provided by different vial manufacturers did however create differences in heat transfer and cycle times, especially where vials did or did not make direct contact with the lyophilizer’s shelves.
The presentation concluded by linking different filling solutions to business cases. Dr. Rathore said that there are equally valid business cases for conventional high-speed machines focused on a single container and for small-scale flexible fillers like those offered by Vanrx.