The UK-based contract manufacturing organisation (CMO) has added Sterility and Bacterial Endotoxin Testing (BET) to its GMP-compliant facility, which will supplement its analytical, stability and microbiological testing capabilities.
Dianne Sharp, managing director at SCM Pharma, said: ‘The launch of these in-house testing services is a major milestone in the firm’s development in that it allows us to fill, test and release sterilised product for our clients all under one roof.’
She added: ‘Not only will this reduce the potential risk of loss, breakage, documentation issues and delays associated with offsite testing but by allocating testing slots straight after sterile filling, our clients are also likely to get their product quicker.’
The sterility testing is performed within a validated grade A environment using a sterility test isolator located in a cleanroom. Using an isolator as opposed to other conventional methods will help reduce the potential for costly delays and lengthy investigations, the company said.
BET is carried out in a designated area of the microbiology laboratory using the Quantitative Turbidimetric Assay technique. Aimed at reducing lead times and minimising risk for client projects, BET is performed using GMP compliant computer software allowing quick generation of COAs and results.
The new testing services are a logical addition to SCM’s Pharma’s aseptic processing and terminal sterilisation capabilities, allowing the company to fill ampoules, vials and syringes.
SCM Pharma specialises in the fill/finish of novel, difficult and dangerous drug products. It has expertise in the filling of highly potent products, radio-labelled compounds and non-live biologicals.
