Jenny Ekegren, Cobra Biologics01.29.16
The fill/finish operations for biotherapeutics is a critical, but often overlooked hurdle in the production process for these products, especially for early phase clinical evaluation. From a processing perspective the products are complex and fragile however terminal sterilization is not an option. All products need to be sterilized by point of fill filtration, which from a regulatory perspective is a challenge in itself.
From an operational perspective the products are often highly potent, hugely expensive and complex to produce for early phase studies, plus only very small amounts of material are available. In some cases only 1L of drug substance may have been produced at costs in excess of $500,000. One impact of this is that losses incurred during the filling operation need to be kept to an absolute minimum, not least to ensure that sufficient filled drug product is available to support planned clinical studies.
It is therefore essential that the approach taken by fill/finish facilities to produce the drug product addresses these issues and seeks to reduce process losses to an absolute minimum while retaining regulatory compliance with regard
From an operational perspective the products are often highly potent, hugely expensive and complex to produce for early phase studies, plus only very small amounts of material are available. In some cases only 1L of drug substance may have been produced at costs in excess of $500,000. One impact of this is that losses incurred during the filling operation need to be kept to an absolute minimum, not least to ensure that sufficient filled drug product is available to support planned clinical studies.
It is therefore essential that the approach taken by fill/finish facilities to produce the drug product addresses these issues and seeks to reduce process losses to an absolute minimum while retaining regulatory compliance with regard
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