for Fill & Finish ADC
DESIGNING A SAFEGUARDED FILL & FINISH ADC FACILITY
In the continued war against cancer our customers may consider to establish an antibody drug conjugate (ADC) fill and finish facility. These facilities can face several challenges that come with handling the highly toxic active pharmaceutical ingredients (API) in ADCs. A miniscule amount of product contamination can put manufacturers at risk. Not only an increased risk for contamination is possible, but also a financial risk, as these highly specialised drugs are substantial investments.
In case of high toxicity of a product, Pharmaplan offers to investigate and design highly sophisticated isolators throughout the entire process of the facility. The vial isolator filling line for liquid and lyophilised products can quickly become the project focal point. Beyond general containment improvements such as disposable single use systems, bags and fluid paths, we can optimise primary and secondary levels of containment after a thorough health, safety and environment risk analysis. To reduce the risk of financial loss, process safety and redundancy where applicable are considered within the equipment design to avoid such incidents in the technically best possible way.
By the design of a highly sophisticated fill & finish facility for antibody drug conjugates we can help our customers tackling both contamination and financial risk.