Reducing Volume Losses During Fill and Finish

The loss of drug product during the filtration and fill process presents a major challenge to pharmaceutical and biologics manufacturers worldwide. For Cobra Biologics, a leading contract manufacturer (CMO) providing aseptic manufacture for all phases of clinical development, limiting the loss of customers’ valuable product is paramount.


To better accommodate high value, small volume filling, for example, with antibody and plasmid APIs, a project was initiated to modify the fill process with the aim of minimising product losses. Careful mapping of the fill process followed by changes in the working procedures and the choice of disposable fluid flow paths, resulted in a more than 10-fold decrease in product waste.


Successful improvement of the process, based on a commercially available system, ensures that a maximum product yield is available for filling and lyophilisation, a factor especially important for small batches of high value drug product.


Cobra will be presenting a poster documenting the findings of this project entitled “Minimising Drug Product Losses in Small Volume Aseptic Filling” at The Universe of Pre-Filled Syringes and Injection Devices PDA conference in Basel, 5–6 November 2013.


Having optimised the filtration process with an impressive reduction in downstream losses to less than 0.1 L, Cobra’s on-going project will be to further minimise volume losses, enhancing customer product yields, by thorough review of product sampling and validation procedures.


Cobra’s state-of-the-art Fill Finish facility was acquired from UniTech Pharma at the end of 2011 and expands an already comprehensive service offering to include sterile drug product production and freeze drying/lyophilisation for a wide range of batch sizes from 1 to 200 L. Utilising fully disposable systems affords Cobra increased flexibility for pre-clinical, clinical and commercial manufacture, and customers’ products can be filled in either single-use syringes (0.5–3 mL) or injected vials (0.5–100 mL) while meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.