Full throttle for vaccine filling

Since the outbreak of the pandemic, Optima Pharma has been making great efforts to adapt existing filling systems for vaccine filling and to build new filling systems with isolators as quickly as possible. "Our employees have been extremely challenged and are delivering top performance worldwide," says Juergen Rothbauer, Managing Director of OPTIMA pharma GmbH. One example for a successful collaboration during the pandemic is with Thermo Fisher, headquartered in Waltham, Massachusetts.

The company’s Pharma Services business provides contract development and manufacturing services, which includes sterile fill operations for COVID-19 vaccines and other critical care medications for pharma companies globally. As a strategic partner with the necessary technological know-how, and end to end drug substance and drug product development and manufacturing capabilities, Optima is helping the company increase capacity for vaccine filling at several of its sites as quickly as possible.

In addition to fast project processes, selecting the right primary packaging materials offers great potential for increasing filling capacities. As is the case for filling lines, the global demand for primary packaging materials has risen in response to the COVID-19 pandemic. Global supply chain leaders have identified vials as a supply chain vulnerability for both COVID-19 and non-COVID-19 products  [1].

Recent US Food and Drug Administration guidance highlights this concern and helps to address it by outlining pathways to facilitate vial and stopper changes  [2].  FDA points to Comparability Protocols (CPs) as well-suited for glass vial changes (such as shifts to Corning’s Valor® Glass), as CPs can support vial changes broadly including across multiple products that use the same container (e.g., group supplements, trans-BLAs). In recent guidance, manufacturers are encouraged to contact the FDA to discuss specific cases that might warrant modified post-approval reporting categories and other risk-based approaches.

As not only investment costs, but also operating costs are very relevant for pharmaceutical companies, the estimation of required cleanroom and isolator space proved to be a major consideration during this project. While raising the speed by almost 70 % from 450 vials to 750 vials per minute, space requirements increased by only 25 % without compromising accessibility of the line. The results expected by Corning could be achieved in the in-depth investigations as shown in Figure 4.

Luca Andretta, Sr. Director within the Pharma Services Technical Operations team at Thermo Fisher said this about his observations during technical assessments: “With Corning glass evaluation and trials we have seen improved quality through reduced risks of glass defects usually seen in normal operation due to Corning’s lower coefficient of friction coating, higher yields as a result of reduced AVI rejects, all of which can allow us to operate our fill/finish lines at higher speeds, resulting in improved overall line outputs. In our experience with Corning glass options, we have concluded that substantial operational and quality improvements may be achieved, with minor qualification and regulatory impact,” Andretta explains  [2].