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, 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 minimizing 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 lyophilization, 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 “Minimizing 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 optimized the filtration process with an impressive reduction in downstream losses to less than 0.1 litre, Cobra’s on-going project will be to further minimize volume losses, enhancing customer product yields, by thorough review of product sampling and validation procedures.

Cobra’s 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 / lyophilization for a wide range of batch sizes from 1 to 200 litres.

Utilizing 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 ml - 3ml) or injected vials (0.5ml - 100ml) while meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.